Registration Dossier
Registration Dossier
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EC number: 701-410-9 | CAS number: -
Endpoint summary
Administrative data
Description of key information
There are no skin and eye irritation data for the registered substance, trimethoxy(methyl)silane and its reaction products with 3-aminopropyltriethoxysilane and [3-(2,3-epoxypropoxy)propyl]trimethoxysilane (EC 701 -410 -9). Therefore, data for its constituents have been used for these endpoints.
Block A
Trimethoxy(methyl)silane (CAS 1185-55-3)
In the in vivo skin irritation study with trimethoxy(methyl)silane, conducted according to OECD Test Guideline 404 and in compliance with GLP, the substance was concluded to be not irritating to rabbit skin (Hazleton France, 1992).
In the in vivo eye irritation study with trimethoxy(methyl)silane, conducted according to OECD Test Guideline 405 and in compliance with GLP, the test substance was concluded to be not irritating to rabbit eyes (Hoechst, 1991).
Triethoxy(methyl)silane (CAS 2031-67-6)
In the in vivo skin irritation study with triethoxy(methyl)silane, conducted according to OECD Test Guideline 404 and in compliance with GLP, the test substance was concluded to be not irritating to rabbit skin (Hazleton France, 1992c).
In the in vivo eye irritation study with triethoxy(methyl)silane, conducted according to a protocol similar to OECD Test Guideline 405 and in compliance with GLP, the test substance was concluded to be not irritating to rabbit eyes (Bushy Run Research Center, 1991).
Block B
3-Aminopropyl(triethoxy)silane (CAS 919-30-2)
In the in vivo skin irritation study with 3-aminopropyl(triethoxy)silane, conducted according to a protocol similar to OECD Test Guideline 404 but without information on GLP compliance, the test substance was concluded to be corrosive to rabbit skin (Bushy Run Research Center, 1990).
In the in vivo eye irritation study with 3-aminopropyl(triethoxy)silane, conducted according to a protocol similar to OECD Test Guideline 405 and in compliance with GLP, the test substance was concluded to irreversible eye damage (Bushy Run Research Center, 1989).
3-(Trimethoxysilyl)propylamine (CAS 13822-56-5)
In the in vivo skin irritation study with 3-(trimethoxysilyl)propylamine, conducted according to OECD Test Guideline 404 and in compliance with GLP, the test substance was concluded to be irritating to rabbit skin (WIL Research Laboratories, 2003).
Trimethoxy(methyl)silane and its reaction products with [3-(2,3-epoxypropoxy)propyl]trimethoxysilane and 3-(trimethoxysilyl)propylamine (EC No. 701 -408 -8)
In the key skin irritation study, conducted according to OECD Test Guideline 404 and in compliance with GLP, the test material trimethoxy(methyl)silane and its reaction products with [3-(2,3-epoxypropoxy)propyl]trimethoxysilane and 3-(trimethoxysilyl)propylamine (EC 701 -408 -8) was reported to be not irritating to skin (Dow Corning Corporation, 1990c).
In the key eye irritation study, conducted according to OECD Test Guideline 405 and in compliance with GLP, the test material, trimethoxy(methyl)silane and its reaction products with [3-(2,3-epoxypropoxy)propyl]trimethoxysilane and 3-(trimethoxysilyl)propylamine, was reported to be irritating to eyes (Dow Corning Corporation, 1990d).
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 16/09/1991 - 17/02/1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River France
- Age at study initiation: adult
- Weight at study initiation: 2.5 +/- 0.2kg
- Housing: individually housed in polystyrene cages with perforated flooring
- Diet: standard rabbit diet, 150g/animal/day
- Water: ad libitum
- Acclimation period: minimum 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 30 to 70%
- Photoperiod (hrs dark / hrs light): 12/12
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml - Duration of treatment / exposure:
- 4 hours
- Observation period:
- The cutaneous examinations were performed for eythema and oedema according to a numerical scale, 1, 24, 48 and 72 hours after removal of the bandage. Observation in the case of a corrosive action of the test article may be studied by observation of the animals up to 14 days.
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: on the back or one of the flanks
- Type of wrap if used: semi occlusive patch
REMOVAL OF TEST SUBSTANCE
- Washing (if done): excess test article which has not penetrated will be wiped away with a gauze pad moistened with distilled water (or a non irritant solvent).
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to OECD - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Not irritating.
- Other effects:
- None reported.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the in vivo skin irritation study with trimethoxy(methyl)silane, conducted according to OECD Test Guideline 404 and in compliance with GLP, the substance was concluded to be not irritating to rabbit skin.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 16.09.1991 to 17.02.1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: New Zealand hybrid albino
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Bancel, St Rambert D'Albon, FRANCE
- Age at study initiation: "adult"
- Weight at study initiation: 2.5 +/-0.2 kg
- Housing: 1/cage; polystyrene cage with perforated flooring
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: at least 1 wk
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-3
- Humidity (%): 30-70
- Air changes (per hr): no details given
- Photoperiod (hrs dark / hrs light): 12 h/12 h
IN-LIFE DATES: no details given - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL
- Concentration: neat - Duration of treatment / exposure:
- 4 h
- Observation period:
- 1, 24, 48, 72 h. No further observation required.
- Number of animals:
- Six males
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
- % coverage: not stated
- Type of wrap if used: 8 layer gauze pad, covered with perforated tape on crimped gauze bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): protocol states that excess test material should be wiped away with gauze moistened with distilled water if necessary. It is not clear if this was the case.
- Time after start of exposure: 4 h
SCORING SYSTEM: as given in OECD 404 - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- See Table 1.
- Other effects:
- None reported.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the in vivo skin irritation study with triethoxy(methyl)silane, conducted according to OECD Test Guideline 404 and in compliance with GLP, the test substance was concluded to be not irritating to rabbit skin.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- See below
- Principles of method if other than guideline:
- No guideline is specified. This study approximates in many respects to OECD Test Guideline 404 including observations for 14 days. The neat material (0.5 ml) was held in occlusive contact for 1 h or 3 min with the shaved skin of 6 rabbits. Insufficient details are given on the purity of the test substance, animals used, test site and animal housing conditions.
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no details given
- Age at study initiation: no details given
- Weight at study initiation: no details given
- Housing: no details given
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: no details given
ENVIRONMENTAL CONDITIONS
no details given
IN-LIFE DATES: no details given - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 ml
- Concentration: neat - Duration of treatment / exposure:
- 1 h
3 min - Observation period:
- 14 days
- Number of animals:
- 6 (for each exposure time)
Two animals in the 1-min test were terminated after day 10 for reasons of space. - Details on study design:
- TEST SITE
- Area of exposure: not stated
- % coverage: not stated
- Type of wrap if used: gauze covered with loosely held occlusive wrap
REMOVAL OF TEST SUBSTANCE
- Washing: excess removed after exposure
- Time after start of exposure: 1 h; 3 min
SCORING SYSTEM: Draize - Irritation parameter:
- erythema score
- Remarks:
- 1 h contact
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- 1 h contact
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- 1 h contact
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- 1 h contact
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2.66
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- 1 h contact
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- 1 h contact
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- 1 h contact
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- 1 h contact
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- 1 h contact
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- 1 h contact
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- 1 h contact
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- 1 h contact
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- 3 min contact
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- 3 min contact
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- 3 min contact
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- 3 min contact
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- 3 min contact
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- 3 min contact
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- 3 min contact
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- 3 min contact
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- 3 min contact
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- 3 min contact
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- 3 min contact
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- 3 min contact
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- 1-Hour occlusive contact caused well-defined to moderate erythema and slight to moderate oedema in all 6 animals, which was still present at day 3 observation but not at day 7. Necrosis that was full thickness in 2/6 and superficial in 2/6 was evident until observation at day 10, but absent at day 14. Ecchymosis (a hemorrhagic area) was apparent in 4/6 within 2 hours but absent by day 2. Scabbing, desquamation or alopecia were still present in all 4 of the remaining animals at termination on day 14. See table 1.
Exposure for 3 minutes caused slight to well-defined erythema and very slight to slight oedema in 6/6 rabbits that remained in some animals until day 3 but was not evident on day 7. The only other effect reported was desquamation present in 6/6 animals at the final day 7 observation. See table 2. - Other effects:
- None reported.
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Conclusions:
- In the in vivo skin irritation study with 3-aminopropyl(triethoxy)silane, conducted according to a protocol similar to OECD Test Guideline 404 but without information on GLP compliance, the test substance was concluded to be corrosive to rabbit skin.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- from 20 Jan 2003 to 3 Feb 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- observations only to 7 days, when effects still evident
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Covance Research Products Inc., Denver, PA, USA
- Age at study initiation: "young adult"
- Weight at study initiation: 3.018-3.171 kg
- Housing: 1/suspended wire mesh cage
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.5-19
- Humidity (%): 43.6-48.0. (The summary indicates the maximum humidity was 49.3%, the data provided do not appear to support this.)
- Photoperiod (hrs dark / hrs light): 12 h/12 h
IN-LIFE DATES: From: 2003-01-20 To: 2003-02-03 (14 days - although observational data are only given for 7 days) - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 ml
- Concentration: neat - Duration of treatment / exposure:
- 3 min
1 h
4 h - Observation period:
- 3-min: immediately and 1 (or 24) h
1-h: immediately and 24, 48, 72 h, and days 4 and 7
4-h: 1, 24, 48, 72 h, and days 4 and 7 - Number of animals:
- 1 rabbit: 3-min, 1 h, 4 h
2 futher rabbits: 4 h - Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- % coverage: not stated
- Type of wrap if used: 2-ply gauze secured with Micropore tape, overwrapped with gauze binder secured with Dermiform tape.
REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 3 min, 1 h, 4 h
SCORING SYSTEM: Draize, 1965. Mean of 1, 24, 48, 72 h - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- 4-Hour exposure caused erythema and oedema (grade 1 or 2) in up to three animals; erythema persisted to the final observation at 7 days. See tables 1-3.
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- In the in vivo skin irritation study with 3-(trimethoxysilyl)propylamine, conducted according to OECD Test Guideline 404 and in compliance with GLP, the test substance was concluded to be irritating to rabbit skin based on persistance of irritation reactions.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 7 August 1990 to 10 August 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: not specified
- Stability under test conditions: not specified
- Solubility and stability of the test substance in the solvent/vehicle: The test item was applied undiluted.
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test item was applied undiluted.
- Preliminary purification step: none
- Final dilution of a dissolved solid, stock liquid or gel: not applicable
- Final preparation of a solid: not applicable - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazelton, Kalamazoo, Michigan
- Age at study initiation: young, no further information given
- Weight at study initiation: 2.27 - 2.33 kg
- Housing: All rabbits were housed individually in clean, stainless steel cages
- Diet (e.g. ad libitum): Purina Lab Rabbit Chow, ad libitum
- Water (e.g. ad libitum): fresh water, as libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled, but range not specified
- Humidity (%): controlled, but range not specified
- Air changes (per hr): controlled, but range not specified
- Photoperiod (hrs dark / hrs light): controlled, but range not specified - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): not applicable
VEHICLE: Not used
NEGATIVE CONTROL: Not used
POSITIVE CONTROL: Not used - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 4
- Details on study design:
- TEST SITE
- Area of exposure: dorsal area
- % coverage: approximately 6 cm², percentage not specified
- Type of wrap if used: porous gauze dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with tap water
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
at 1, 24, 48 and 72 hours
SCORING SYSTEM:
- Method of calculation: Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No effects on body weight gain, food consumption or behaviour were observed in any of the test animals. No skin irritation was observed in any of the test animals.
- Other effects:
- - Other adverse local effects: no effects
- Other adverse systemic effects: no effects - Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the skin irritation study, conducted according to OECD Test Guideline 404 and in compliance with GLP, the test material trimethoxy(methyl)silane and its reaction products with [3-(2,3-epoxypropoxy)propyl]trimethoxysilane and 3-(trimethoxysilyl)propylamine was reported to not be irritating to skin.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Scientifique des Dombes, France
- Age at study initiation: 10-11 weeks
- Weight at study initiation: 2.4-2.6 kg
- Housing: individually in stainless steel cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 'Under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study. '
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): 10-14
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 4 hours
- Observation period:
- The skin reactions were assessed at ca. 1, 24, 48 and 72 hours as well as 7, 10 and 14 days after the removal of the gauze patch and test item.
- Number of animals:
- 1 male, 2 females
- Details on study design:
- TEST SITE
- Area of exposure: left flank
- coverage: 10 x 10 cm
- Type of wrap if used: surgical gauze patch, covered with semi-occlusive dressing which was then wrapped around the abdomen and anchored with tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours
SCORING SYSTEM: The skin reaction was assessed according to te numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992 (based on teh Draize score system) - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Application of the test item to healthy intact rabbit skin resulted in a primary irritation index of 1.33. Local signs (mean values from 24 to 72 hours) consisted of grade 1.22 erythema and grade 0.11 oedema. Very slight to well defined erythema was observed in all animals 1 hour after treatment and persisted in two animals up to the 48 hour reading and in the other animal up to the 72 hour reading. Very slight swelling at the test site was noted in one female 1 hour after the treatment and in the other female 24 hours after treatment. Slight scaling of the skin at the test site was evident in the male at the 72 hour reading. In addition, the skin of this animal was noted to be dry and inelastic from 24 to 72 hours after treatment. Slight to moderate scaling at the test site was also noted in both the females from 7 to 10 days or from 72 hours to 10 days after treatment. The skin of these two female animals was similarly noted to be dry and inelastic from 48 to 72 hours or from 24 to 72 hours after treatment. All skin reactions had cleared within 14 days of treatment. No staining by the test item of the treated skin was observed. No irreversible alterations of the treated skin were observed nor were corrosive effects evident on the skin.
- Other effects:
- No clinical signs or systemic toxicity were observed in the animals during the study and no mortality occurred.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the in vivo skin irritation study with N-ethyl-3-trimethoxysilyl-2-methyl-propanamine, conducted according to OECD Test Guideline 404 and in compliance with GLP, the test substance was concluded to be not irritating to rabbit skin.
Referenceopen allclose all
Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Erythema |
Edema |
Max. score: 4 |
Max. score: 4 |
|
60 min |
1/0/1/1/1/1 |
0/0/0/0/0/0 |
24 h |
0/0/0/1/1/0 |
0/0/0/0/0/0 |
48 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
72 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
Average 24h, 48h, 72h |
0.1 |
0 |
Reversibility* |
c |
- |
time for reversion |
48 h |
- |
* Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Irritant/corrosive response data (mean for 6 animals) at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Erythema & eschar (mean of 6) |
Edema (mean of 6) |
Other effects (number of animals with each effect shown) |
Max. score: 4 |
Max. score: 4 |
||
2 h |
1.5 |
1.0 |
- |
24 h |
1.7 |
1.2 |
- |
48 h |
1.5 |
0.7 |
1D |
72 h |
1.2 |
0.2 |
1D |
Day 7 |
0.0 |
0.0 |
6D |
Mean 24, 48, 72 h |
1.5 |
0.7 |
- |
Reversibility* |
nc |
||
Average time (unit) for |
Not fully reversed within 7 days |
||
* Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
N+ = full thickness necrosis
N = superficial necrosis
D = desquamation
E = ecchymosis
S = scab formation
A = alopecia
Table 1: Irritant/corrosive response data for each animal after exposure for 3 minutes, at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Erythema |
Edema |
Max. score: 4 |
Max. score: 4 |
|
Immediately after exposure |
0 |
0 |
1 h* |
0 |
0 |
Reversibility* |
n/a |
n/a |
* the text describes a second observation at 1 h, the tabulated data describes the second observation at 24 h.
** Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Table 2: Irritant/corrosive response data for each animal after exposure for 1 hour, at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Erythema |
Edema |
Max. score: 4 |
Max. score: 4 |
|
Immediately after exposure |
0 |
0 |
24 h |
1 |
0 |
48 h |
1 |
0 |
72 h |
2a |
1 |
4 days |
1 |
1 |
7 days |
0b |
0 |
Reversibility* |
c |
n/a |
Average time (unit) for reversion |
7 days |
|
* Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
a erythema spreading outside dosed site to
b = desquamation
Table 3: Irritant/corrosive response data for each animal after exposure for 4 hour, at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Erythema |
Edema |
Max. score: 4 |
Max. score: 4 |
|
60 min |
0/1/0 |
0/0/0 |
24 h |
1/2/1 |
0/2/1 |
48 h |
1/2/1 |
0/1/0 |
72 h |
2a/2/1 |
1/1/1 |
4 days |
2/1b/1 |
1/1/1 |
7 days |
0b/1b/1b |
0/0/0 |
Average 24 h, 48 h, 72 h (EU criteria) |
1.3/2/1 |
0.3/1.3/0.7 |
Average 1 h, 24 h, 48 h, 72 h (as given in report); PII=1.8 |
1.2 |
0.6 |
Reversibility* |
unclear |
c |
Average time (unit) for reversion |
No data at 14 days |
Day 7 |
* Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
a erythema spreading outside dosed site to
b = desquamation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 08.10.1991 to 18.10.1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: 3-5 months
- Weight at study initiation: 3.1 - 3.9 kg
- Housing:
- Diet: Altromin 2123 ad libitum
- Water: deionised tap water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3 °C
- Humidity (%): 55 +/- 20%
- Photoperiod (hrs dark / hrs light): 12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 ml
- Concentration: Neat - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: fluorescein (0.01% ) - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Mild to moderate conjunctival redness and discharge were observed in all test animals 1 hour post-instillation. Mild chemosis was also observed at this time point. All effects were fully resolved by the 24-hour observation.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the in vivo eye irritation study with trimethoxy(methyl)silane, conducted according to OECD Test Guideline 405 and in compliance with GLP, the test substance was concluded to be not irritating to rabbit eyes.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- limited details on housing, test animals and test substance identity reported
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: No data
- Housing: No data
- Diet : Commerical diet was available ad libitum
- Water : Municipal water was available ad libitum
- Acclimation period: No data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data
IN-LIFE DATES: From: To: No data - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL (neat) - Duration of treatment / exposure:
- Single exposure, without washing. Potential duration of study 14 days - appears to have been terminated at 3 days, probably because no irritation was observed by this time point.
- Observation period (in vivo):
- Examined: 1, 6, 24, 48 and 72 h.
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing : no washing reported
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: fluorescein stain, no other details given - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Minor transient eye irritation. See table 1.
- Other effects:
- None reported.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the in vivo eye irritation study with triethoxy(methyl)silane, conducted according to a protocol similar to OECD Test Guideline 405 and in compliance with GLP, the test substance was concluded to be not irritating to rabbit eyes.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- not specified
- Remarks:
- SIAR (2003) notes that this laboratory was GLP certified at the date of this study
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: no details given
- Age at study initiation: : no details given
- Weight at study initiation: no details given
- Housing: no details given
- Diet: standard diet ad libitum
- Water : drinking water ad libitum
- Acclimation period: no details
ENVIRONMENTAL CONDITIONS
no details given
IN-LIFE DATES: no details given - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye usually serves as the control
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 ml, 0.005 ml
The dose is instilled into the lower conjunctival sac of one eye per animal. - Duration of treatment / exposure:
- The eyelids are held together for one second. Eyes unwashed.
- Observation period (in vivo):
- Observation to 21 days in some cases
- Number of animals or in vitro replicates:
- 6 (3/sex)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: unwashed
The eyes were scored at one and five hours, and at 1, 2, 3, 7 and 14 days after dosing.
SCORING SYSTEM: after Draize, 1959
TOOL USED TO ASSESS SCORE: fluorescein (for 1-day reading) - Irritation parameter:
- cornea opacity score
- Remarks:
- 0.1 ml
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Remarks:
- 0.1 ml
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Remarks:
- 0.1 ml
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Remarks:
- 0.1 ml
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Remarks:
- 0.1 ml
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 3.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Remarks:
- 0.1 ml
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- 0.1 ml
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- 0.1 ml
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- 0.1 ml
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- 0.1 ml
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- 0.1 ml
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- 0.1 ml
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- 0.1 ml
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- 0.1 ml
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- 0.1 ml
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- 0.1 ml
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- 0.1 ml
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- 0.1 ml
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- 0.1 ml
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- 0.1 ml
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- 0.1 ml
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- 0.1 ml
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- 0.1 ml
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- 0.1 ml
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Remarks:
- 0.005 ml
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Remarks:
- 0.005 ml
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Remarks:
- 0.005 ml
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Remarks:
- 0.005 ml
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Remarks:
- 0.005 ml
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Remarks:
- 0.005 ml
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- 0.005 ml
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- 0.005 ml
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- 0.005 ml
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- 0.005 ml
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- 0.005 ml
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- 0.005 ml
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- 0.005 ml
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- 0.005 ml
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- 0.005 ml
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- 0.005 ml
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- 0.005 ml
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- 0.005 ml
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- 0.005 ml
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- 0.005 ml
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- 0.005 ml
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- 0.005 ml
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- 0.005 ml
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- 0.005 ml
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- 0.1 ml: severe corneal injury, iritis, severe conjuctival irritation and necrosis of the conjunctivae within 1 h. Because of the severe, possibly irreversible, irritation at 7 days all animals were sacrificed. See table 1.
0.005 ml: minor to severe corneal injury with necrosis of the conjunctivae within 1 h. Two of six had recovered at 7 days and only 2 showed clear effects at 14 and 21 days. See table 2. - Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- In the in vivo eye irritation study with 3-aminopropyl(triethoxy)silane, conducted according to a protocol similar to OECD Test Guideline 405 and in compliance with GLP, the test substance was concluded to irreversible eye damage.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2 August 1990 to 01 October 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: not specified
- Stability under test conditions: not specified
- Solubility and stability of the test substance in the solvent/vehicle: The test item was applied undiluted.
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test item was applied undiluted.
- Preliminary purification step: none
- Final dilution of a dissolved solid, stock liquid or gel: not applicable
- Final preparation of a solid: not applicable - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hazelton, Kalamazoo, Michigan
- Age at study initiation: young, no further information given
- Weight at study initiation: 2.27 - 2.33 kg
- Housing: All rabbits were housed individually in clean, stainless steel cages
- Diet: Purina Lab Rabbit Chow, ad libitum
- Water: fresh water, as libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled, but range not specified
- Humidity (%): controlled, but range not specified
- Air changes (per hr): controlled, but range not specified
- Photoperiod (hrs dark / hrs light): controlled, but range not specified - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): not applicable
VEHICLE: not used - Duration of treatment / exposure:
- single instillation
- Observation period (in vivo):
- up to 14 days
- Number of animals or in vitro replicates:
- two groups of three animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no washing done for group one and washing done for group two 30 seconds after instillation.
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: Fluorescein - Irritation parameter:
- cornea opacity score
- Remarks:
- unwashed eye
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Remarks:
- unwashed eye
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Remarks:
- unwashed eye
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- unwashed eye
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- unwashed eye
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- unwashed eye
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- unwashed eye
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- unwashed eye
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- unwashed eye
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- unwashed eye
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- unwashed eye
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Remarks:
- washed eye
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Remarks:
- washed eye
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Remarks:
- washed eye
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- washed eye
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- washed eye
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- washed eye
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- washed eye
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- washed eye
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- washed eye
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- washed eye
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- washed eye
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- washed eye
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No effects were observed in body weight gain or food consumption of the rabbits. Eye irritation was noted in group one animals with unwashed eyes after instillation. No eye irritation was noted in group two animals with washed eyes following treatment (30 seconds after instillation).
Group 1 (unwashed):
Slight to moderate swelling and iritis and slight damage to cornea were noted at 24, 48 and 72 hours. All eyes appeared normal by day 14 of observation period.
Group 2 (washed after 30 seconds):
Slight to severe pain after instillation of the test material. At 1 and 24 hours, slight to moderate conjunctival redness with swelling in all rabbits and slight corneal injury was observed in one animal at 24 hours. At 48 hours observation, slight redness with swelling was seen in 2/3 rabbits and one animal still showed slight corneal injury and slight iritis. All treated eyes appeared normal by day 7 of the observation period. - Other effects:
- Not specified
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- In the eye irritation study, conducted according to OECD Test Guideline 405 and in compliance with GLP, the test material, trimethoxy(methyl)silane and its reaction products with [3-(2,3-epoxypropoxy)propyl]trimethoxysilane and 3-(trimethoxysilyl)propylamine, was reported to be irritating to eyes.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevages Scientifique Dombes, France
- Age at study initiation: 10-11 weeks
- Weight at study initiation: 2.3-2.4 kg
- Housing: individually in stainless steel cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 'under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): 10-14
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- Single instillation.
- Observation period (in vivo):
- Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours, as well as 7, 10, 14, 17 and 21 days after test item application.
- Number of animals or in vitro replicates:
- 1 male, 2 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 48 hours
SCORING SYSTEM: The ocular reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992 (based on Draize scoring system).
TOOL USED TO ASSESS SCORE: diagnostic-lamp - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 72 hours
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 10 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 17 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 17 days
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- A slight to marked opacity, affecting up to the whole area of the cornea at most readings, was evident in the male throughout the observation period and was still present on day 21. A slight corneal opacity, affecting approximately one quarter or less of the cornea, was observed in one female from the 72-hour to the 17-day reading. The other female showed a moderate to marked opacity, affecting up to the whole cornea at every reading, from 1 hour to 10 days after treatment. the cornea of this animal was opaque from 14 to 21 days after treatment. In addition, sub-corneal bleeding was observed in the male 17 days after treatment and in one female from 7 to 17 days after treatment.
The light reflex in the iris was delayed/reduced in the male at the 1 hour, 10 day, 14 day, 17 day and 21 day readings and was absent at the 72 hour and 7 day readings. The light reflex in one female was absent at all readings from 1 hour to 10 days after treatment. On test days 14 to 21 the iris of this animal was not discernible through the opacity. No abnormal findings were observed in the iris of the female at any reading.
Moderate to marked reddening of the conjunctivae was observed in the male throughout the observation period and moderate reddening was still evident on day 21. Slight reddedning was noted in one female from 1 hour to 7 days after treatment and slight to moderate reddening was evident in the other female from 1 hour to 14 days after treatment.
Moderate to marked swelling (with partial eversion of lids or with half closed to closed lids) was observed in the male from 1 hour to 17 days after treatment and slight swelling was still present on day 21. Slight swelling was noted in the one female from the 1 hour to the 7 day reading and slight to marked swelling was noted in the other female from the 1 hour to the 14 day reading.
The sclera could not be assessed in the male from 1 hour to 10 days after treatment or in one female from 1 to 72 hours after treatment due to swelling of the conjunctivae. Moderate reddening was observed in the male at the 14 day reading and slight to moderate reddening persisted up to termination on day 21. Slight to marked reddening of the sclera was evident in one female from 7 to 21 days after treatment. No abnormal findings were noted in the sclera of the other female at any reading.
At the 1 hour reading all animals were noted to have discharge with moistening of the lids and hair, and considerable area around the eye. Discharge, of various severity, continued to be observed in the male up to the day 17 reading, in one female up to the 24 hour reading and in the other female up to the 72 hour reading. No staining of the treated eyes by the test item was observed. - Other effects:
- No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- In the in vivo eye irritation study with N-ethyl-3-trimethoxysilyl-2-methyl-propanamine, conducted according to OECD Test Guideline 405 and in compliance with GLP, the test substance was concluded to be causing irreversible eye damage rabbit eyes.
Referenceopen allclose all
Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
60 min |
0/0/0/0/0/0 |
1/1/0/0/0/0 |
1/1/1/1/1/1 |
1/0/0/0/0/0 |
24 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
1/0/0/0/0/0 |
0/0/0/0/0/0 |
48 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
72 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
Average 24h, 48h, 72h |
0 |
0 |
0.06 |
0 |
Reversibility*) |
n/a |
c |
c |
c |
Average time for reversion |
n/a |
24 h |
48 h |
24 h |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Discharge was reported in 2/6 at the 1- and 6-h observations.
Table 1: Irritant/corrosive response data, mean for 6 animals, dose 0.1 ml
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Discharge |
||
Opacity Max. score: 4 |
Area involved Max. score 4 |
Congestion/swelling Max. score: 2 |
Redness Max. score: 3 |
Chemosis Max. score: 4 |
Discharge Max. score: 3 |
||
1 h |
2.7 |
3.3 |
*1 |
2.0 |
1.7 |
3.0 |
|
4 h |
2.8 |
2.7 |
*1 |
2.0 |
2.0 |
2.0 |
|
24 h |
2.5 |
2.2 |
1.0 |
2.2 |
1.7 |
3.0 |
|
48 h |
2.8 |
2.2 |
1.0 |
2.3 |
1.5 |
2.8 |
|
72 h |
3.0 |
2.5 |
*1 |
2.3 |
1.7 |
2.7 |
|
7 days |
3.7 |
3.7 |
* |
1.5 |
1.2 |
1.7 |
|
Mean for 24, 48, 72 h |
2.8 |
* |
2.3 |
1.6 |
|||
Reversibility |
Considered possibly irreversible |
||||||
* scoring not possible for 1 or more animals, mean for the remainder is given
Table 2: Irritant/corrosive response data, mean for 6 animals, dose 0.005 ml (data from selected time intervals are presented here)
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Discharge |
|
Opacity Max. score: 4 |
Area involved Max. score 4 |
Congestion/swelling Max. score: 2 |
Redness Max. score: 3 |
Chemosis Max. score: 4 |
Discharge Max. score: 3 |
|
1 h |
1.7 |
2.2 |
1.0 |
2.0 |
1.3 |
2.7 |
24 h |
1.5 |
2.0 |
1.0 |
2.0 |
1.0 |
2.3 |
48 h |
1.5 |
2.2 |
1.0 |
2.0 |
1.0 |
2.0 |
72 h |
1.0 |
1.8 |
1.0 |
1.5 |
0.7 |
1.2 |
7 days |
1.2 |
1.7 |
0.5 |
0.7 |
0 |
0.7 |
21 days |
0.6 |
0.6 |
0 |
0 |
0 |
0 |
Reversibility |
Not fully reversible within 21 days |
|||||
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
There are no skin and eye irritation data for the registered substance, trimethoxy(methyl)silane and its reaction products with 3-aminopropyltriethoxysilane and [3-(2,3-epoxypropoxy)propyl]trimethoxysilane. Therefore, data for its constituents have been used for these endpoints.
To support the overall hazard conclusion for the skin and eye irritation endpoints, evidence is also taken from the in vivo skin sensitisation study in guinea pigs for the registered substance, which concludes the test material to be a skin sensitiser. A preliminary dose-range finding study was conducted prior to the main skin sensitisation test, which confirms the irritancy potential of the substance.
A solubility test was performed to define the maximum concentration which was technically applicable to the animals. Solubility was found for the vehicle acetone 99.8%, extra dry, at a concentration of 75%. During the dose-range finding study, two animals were treated topically on one flank with the undiluted test item. Two animals per concentration were treated topically with 75%, 50%, 25% and 12.5% of the test item dissolved in acetone. One animal per concentration was treated topically with 6.25%, 3.125%, 3.1% and 1.5% of the test item dissolved in acetone. Neat test substance was determined to be the highest dose that induced some irritation without systemic effects and was used in the three topical induction phases. During the preliminary phase, grade 1 erythema (no oedema) was observed up to 48 hours, but not at 72 hours after application. During the induction phases 18/20, 20/20 and 20/20 animals had erythema (no oedema) up to 48 hours in induction phase 1, 2 and 3, respectively. During the third induction phase 3 of the 20 animals had erythema that worsened to grade 2 by 48 hours. The erythema observed in all other animals was grade 1. Grade 1 was described as 'discrete or patchy erythema' and grade 2 as 'moderate and confluent erythema'. None of the animals had grade 3 erythema (intense erythema and swelling).
Skin and eye irritation data are available for a number of the constituents of the registered substance, and it is therefore possible to determine the appropriate classification of the substance based on the rules for mixtures specified in Regulation (EC) No 1272/2008.
The available data are summarised in the table below, and then discussed in more detail.
Table 1 Summary of skin and eye irritation data for the constituents of the registered substance
Block |
Chemical Name |
CAS Number |
Skin irritation/corrosion |
Eye irritation/damage |
A |
Trimethoxy(methyl)silane |
1185-55-3 |
Not irritating |
Not irritating |
A |
Triethoxy(methyl)silane |
2031-67-6 |
Not irritating |
Not irritating |
B |
3-aminopropyl(triethoxy)silane |
919-30-2 |
Corrosive (Cat 1B) |
Eye damage (Cat 1) |
B |
3-aminopropyl(trimethoxy)silane |
13822-56-5 |
Irritating (Cat 2) |
No data; predicted to be Cat. 1 based on read-across from 919-30-2 |
EC 701 -408 -8 |
Trimethoxy(methyl)silane and its reaction products with [3-(2,3-epoxypropoxy)propyl]trimethoxysilane and 3-(trimethoxysilyl)propylamine |
None (EC No. 945-567-3) |
Not irritating |
Eye irritant (Cat 2) |
HP for D |
N-ethyl-3-trimethoxysilyl-2-methyl-propanamine |
227085-51-0 |
Not irritating |
Eye damage (Cat 1) |
Block A
Trimethoxy(methyl)silane (CAS 1185-55-3)
In the in vivo skin irritation study with trimethoxy(methyl)silane, conducted according to OECD Test Guideline 404 and in compliance with GLP, the substance was concluded to be not irritating to rabbit skin (Hazleton France, 1992). In the study 0.5 ml of undiluted test material was applied onto the shaved skin of 6 rabbits for 4 hours under semi-occlusive dressing. Following application, skin reactions were evaluated at 1, 24, 48 and 72 hours. Only 2 out of 6 animals had minimal erythema score of 0.33 at 24, 48 and 72 hours. All the other animals had score of 0 at 24, 48 and 72 hours for erythema and oedema.
In the in vivo eye irritation study with trimethoxy(methyl)silane, conducted according to OECD Test Guideline 405 and in compliance with GLP, the test substance was concluded to be not irritating to rabbit eyes (Hoechst, 1991). In the study 0.1 ml of undiluted test material was instilled into the eyes of 3 rabbits. Following instillation, eye reactions were evaluated for up to 72 hours. All the animals had score 0 at 24, 48 and 72 hours for cornea opacity, iris, conjunctivae and chemosis.
The substance is a part of Block A. It also shares a common silanol hydrolysis product, methylsilanetriol, with the second Block A consituent triethoxy(methyl)silane (CAS 2031-67-6).
Triethoxy(methyl)silane (CAS 2031-67-6)
In the in vivo skin irritation study with triethoxy(methyl)silane, conducted according to OECD Test Guideline 404 and in compliance with GLP, the test substance was concluded to be not irritating to rabbit skin (Hazleton France, 1992c). In the study 0.5 ml of undiluted test material was applied onto the shaved skin of 6 rabbits under semi-occlusive dressing for 4 hours. Following application, skin reactions were evaluated at 1, 24, 48 and 72 hours. Only 2 out of 6 animals had a erythema score of 0.33 at 24, 48 and 72 hours; the skin appeared normal within 48 hours. All the other animals had erythema and oedema score 0 at 24, 48 and 72 hours.
In the in vivo eye irritation study with triethoxy(methyl)silane, conducted according to a protocol similar to OECD Test Guideline 405 and in compliance with GLP, the test substance was concluded to be not irritating to rabbit eyes (Bushy Run Research Center, 1991). In the study 0.1 ml of undiluted test material was instilled into the eyes of 6 rabbits. Following instillation, eye reactions were evaluated for up to 72 hours. Only one animal had a conjunctiva score of 0.33. All the other animals had score 0 at 24, 48 and 72 hours for cornea opacity, iris, conjunctivae and chemosis.
The substance is a part of Block A. It also shares a common silanol hydrolysis product, methylsilanetriol, with the first Block A constituent trimethoxy(methyl)silane (CAS 1185-55-3).
Block B
3-Aminopropyl(triethoxy)silane (CAS 919-30-2)
In the in vivo skin irritation study with 3-aminopropyl(triethoxy)silane, conducted according to a protocol similar to OECD Test Guideline 404 but without information on GLP compliance, the test substance was concluded to be corrosive to rabbit skin (Bushy Run Research Center, 1990). In the study 0.5 ml of undiluted test material was applied onto the shaved skin of 6 rabbits under occlusive dressing for 3 minutes or 1 hour. Following application, skin reactions were evaluated for up to 14 days. 1-Hour occlusive contact caused well-defined to moderate erythema and slight to moderate oedema in all 6 animals, which was still present at day 3 observation but not at day 7. Necrosis that was full thickness in 2/6 and superficial in 2/6 was evident until observation at day 10, but absent at day 14. Ecchymosis (a haemorrhagic area) was apparent in 4/6 within 2 hours but absent by day 2. Scabbing, desquamation or alopecia were still present in all 4 of the remaining animals at termination on day 14.
Exposure for 3 minutes caused slight to well-defined erythema and very slight to slight oedema in 6/6 rabbits that remained in some animals until day 3 but was not evident on day 7. The only other effect reported was desquamation present in 6/6 animals at the final day 7 observation.
In the in vivo eye irritation study with 3-aminopropyl(triethoxy)silane, conducted according to a protocol similar to OECD Test Guideline 405 and in compliance with GLP, the test substance was concluded to irreversible eye damage (Bushy Run Research Center, 1989). In the study 0.1 and 0.0005 ml of undiluted test material was instilled into the eyes of 3 male and 3 female rabbits. Following application, the eyelids are held together for one second and eye reactions were scored at one and five hours, and at 1, 2, 3, 7 and 14 days after dosing. At 0.1 ml there was severe corneal injury, iritis, severe conjunctival irritation and necrosis of the conjunctivae within 1 hour. Because of the severe, possibly irreversible, irritation at 7 days all animals were sacrificed. At 0.005 ml there was minor to severe corneal injury with necrosis of the conjunctivae within 1 hour. Two of six animals had recovered at 7 days and only 2 showed clear effects at 14 and 21 days.
The substance is a minor constituent of the registered substance, part of Block B. It also shares a common silanol hydrolysis product, 3-aminopropylsilanetriol, with the other Block B constituent 3-(trimethoxysilyl)propylamine (CAS 13822-56-5).
3-(Trimethoxysilyl)propylamine (CAS 13822-56-5)
In the in vivo skin irritation study with 3-(trimethoxysilyl)propylamine, conducted according to OECD Test Guideline 404 and in compliance with GLP, the test substance was concluded to be irritating to rabbit skin (WIL Research Laboratories, 2003). In the study 0.5 ml of undiluted test material was applied onto the shaved skin of 1 rabbit for 3 minutes, 1 hour or 4 hours and on additional 2 rabbits for 4 hours under semi-occlusive dressing. Following the 3-minute application, the skin reactions were assessed are at 1 and 24 hours; following 1-hour and 4-hour applications, the skin reactions were assessed at 24, 48, 72 hours, and days 4 and 7. No skin reactions were observed after 3-minute exposure period. Erythema score 1.33 and oedema score 0.33 at 24, 48 and 72 hours were observed in the animal exposed to the test material for 1 hour. All skin reactions disappeared by day 7. 4-Hour exposure caused erythema and oedema (grade 1 or 2) in up to three animals. The erythema persisted to the final observation at 7 days.
The substance is a minor constituent of the registered substance, part of Block B. It also shares a common silanol hydrolysis product, 3-aminopropylsilanetriol, with the other Block B constituent 3-aminopropyl(triethoxy)silane (CAS 919-30-2).
Trimethoxy(methyl)silane and its reaction products with [3-(2,3-epoxypropoxy)propyl]trimethoxysilane and 3-(trimethoxysilyl)propylamine (EC No. 701 -408 -8)
In the key skin irritation study, conducted according to OECD Test Guideline 404 and in compliance with GLP, the test material trimethoxy(methyl)silane and its reaction products with [3-(2,3-epoxypropoxy)propyl]trimethoxysilane and 3-(trimethoxysilyl)propylamine was reported to be not irritating to skin (Dow Corning Corporation, 1990c). Following a single 4-hour application of 0.5 ml of undiluted test item onto the previously clipped dorsal area of 4 rabbits, no signs of erythema or oedema were noted in any of the test animals. Furthermore, no effects were observed on body weight gain, food consumption or behaviour in any of the test animals.
In the key eye irritation study, conducted according to OECD Test Guideline 405 and in compliance with GLP, the test material, trimethoxy(methyl)silane and its reaction products with [3-(2,3-epoxypropoxy)propyl]trimethoxysilane and 3-(trimethoxysilyl)propylamine, was reported to be irritating to eyes (Dow Corning Corporation, 1990d). Following a single instillation of 0.1 ml undiluted test item into the right eye of two groups of three rabbits, no effects were observed in body weight gain or food consumption of the rabbits. When the eyes were washed 30 seconds after instillation, no eye irritation occurred. Although, animals experienced slight to severe pain after instillation of the test material. In the animals with unwashed eyes following instillation, slight to moderate swelling, iritis and slight damage to cornea were noted at 24, 48 and 72 hours. All eyes appeared normal by day 14 of the observation period. At 1 and 24 hours, slight to moderate conjunctival redness with swelling in all rabbits and slight corneal injury was observed in one animal at 24 hours. At 48 hours observation, slight redness with swelling was seen in 2/3 rabbits and one animal still showed slight corneal injury and slight iritis. All treated eyes appeared normal by day 7 of the observation period.
This source substance is the methoxy analogue of the registered methoxy/ethoxy substance (target). Skin and eye irritation studies for this analogue are included to cover Blocks C to G, and unspecified minor constituents, for which there are no irritation data. The only difference between the target and source substances is one of the three starting materials. The source substance has a starting material, 3-aminopropyl(trimethoxy) silane [237-511-5, 13822-56-5] and the target has the starting material that is the triethoxy analogue, 3-aminopropyl(triethoxy)silane [213-048-4, 919-30-2]. Therefore, the target substance has additional ethoxy constituents. However, whether ethoxy or methoxy, the target and source substance constituents hydrolyse to the same respective silanol hydrolysis products. The only difference is the non-silicon hydrolysis product; the target releases methanol and ethanol, whereas the source substance releases methanol only. The small molecule alkoxysilanes of Block A, Block B and those of Block U1 have similar physicochemical properties as the starting materials. Together they constitute about 60-70% of the substance. Blocks C-G and U2 constitute approximately 20-30% of the substances. These are oligomers formed by combination of the monomer starting materials.
Block D
N-ethyl-3-trimethoxysilyl-2-methyl-propanamine
In the in vivo skin irritation study with N-ethyl-3-trimethoxysilyl-2-methyl-propanamine, conducted according to OECD Test Guideline 404 and in compliance with GLP, the test substance was concluded to be not irritating to rabbit skin (RCC, 2001c). In the study 0.5 ml of undiluted test material was applied onto the shaved skin of 3 rabbits for 4 hours under semi-occlusive dressing. Following application, the skin reactions were assessed at 1, 24, 48 and 72 hours as well as 7, 10 and 14 days. Application of the test item resulted in a primary irritation index of 1.33. Local signs (mean values from 24 to 72 hours) consisted of grade 1.22 erythema and grade 0.11 oedema. Very slight to well-defined erythema was observed in all animals at 1 hour after treatment and persisted in two animals up to the 48-hour reading and in the other animal up to the 72-hour reading. Very slight swelling at the test site was noted in one female at 1 hour after the treatment and in the other female at 24 hours after treatment. Slight scaling of the skin at the test site was evident in the male at the 72-hour reading. In addition, the skin of this animal was noted to be dry and inelastic from 24 to 72 hours after treatment. Slight to moderate scaling at the test site was also noted in both the females from 7 to 10 days or from 72 hours to 10 days after treatment. The skin of these two female animals was similarly noted to be dry and inelastic from 48 to 72 hours or from 24 to 72 hours after treatment. All skin reactions had cleared within 14 days of treatment. No staining by the test item of the treated skin was observed. No irreversible alterations of the treated skin were observed nor were corrosive effects evident on the skin.
In the in vivo eye irritation study with N-ethyl-3-trimethoxysilyl-2-methyl-propanamine, conducted according to OECD Test Guideline 405 and in compliance with GLP, the test substance was concluded to be causing irreversible eye damage rabbit eyes (RCC, 2001d). In the study 0.1 ml of undiluted test material was instilled into the eyes of 3 rabbits (1 male and 2 females). Following instillation, the eye reactions were assessed at 1, 24, 48 and 72 hours, as well as 7, 10, 14, 17 and 21 days. A slight to marked opacity, affecting up to the whole area of the cornea at most readings, was evident in the male throughout the observation period and was still present on day 21. A slight corneal opacity, affecting approximately one quarter or less of the cornea, was observed in one female from the 72-hour to the 17-day reading. The other female showed a moderate to marked opacity, affecting up to the whole cornea at every reading, from 1 hour to 10 days after treatment. the cornea of this animal was opaque from 14 to 21 days after treatment. In addition, sub-corneal bleeding was observed in the male 17 days after treatment and in one female from 7 to 17 days after treatment.
Data on this substance are relevant as its silanol hydrolysis product is an analogue of the hydrolysis product of constituents trisilyl(alkylamine), octa(ethoxy/methoxy)-methyl- in Block D. Therefore, data on this substance are included as supporting data for completeness.
Conclusions for skin and eye irritation/corrosion
The overwhelming evidence from in vivo eye irritation studies with aminofunctional alkoxysilanes (PFA, 2013v) is that these substances cause serious eye damage, warranting classification for eye damage Category 1. In contrast, none of the (methoxy/ethoxy)methylsilanes requires classification for eye irritation.
Likewise none of the (methoxy/ethoxy)methylsilanes requires classification for skin irritation. There is no clear trend for the aminofunctional alkoxysilanes where results vary from not irritant to corrosive, but the majority of substances in this group are skin irritating Category 2. As a worst-case, it can therefore reasonably be assumed that the trisilanes and cyclo-trisilanes containing amine groups are irritating to skin. The available guideline skin sensitisation test on the registered substance supports classification as a skin irritant.
Justification for classification or non-classification
- Constituents present at ≥1% should be taken into account
- A corrosive ingredient present at <1% can still contribute to classification
- A weighting factor of 10 should be applied for corrosive substances which are not present at sufficiently high concentrations to lead to classification of the mixture as Cat 1, but may still contribute to classification as Cat 2
The rules for classification of mixtures specified in Regulation (EC) No 1272/2008 indicate that for skin irritation/corrosion:
According to Table 3.2.3 of the Regulation, the relevant equation for the registered substance, trimethoxy(methyl)silane and its reaction products with 3-aminopropyltriethoxysilane and [3-(2,3-epoxypropoxy)propyl]trimethoxysilane is:
%(10 x Skin Corr 1A, 1B or 1C) + %Skin Irrit. 2 ≥10% → Skin Irrit. 2
The relevant constituents to be taken into account for the overall classification of the registered substance are Constituents D (concentration range 5-20 %), C (concentration range 5-20 %) and B (concentration range 0-10 %) of which all are known or predicted to be skin irritating Cat 2, with the exception of 3-aminopropyl(triethoxy)silane which is skin corrosive Cat. 1B. Based on the total concentration range of Constituents B, C and D, the registered substance requires classification for skin irritation Cat 2.
All of the amine-containing constituents, Constituents D (concentration range 5-20 %), C (concentration range 5-20 %) and B (concentration range 0-10 %), are known or predicted to be eye damaging Cat. 1. Therefore, based on their concentration ranges, the registered substance also requires classification for irreversible eye damage Cat 1 according to Table 3.3.3 of Regulation (EC) No 1272/2008.
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