Registration Dossier
Registration Dossier
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EC number: 238-883-1 | CAS number: 14814-09-6
Endpoint summary
Administrative data
Description of key information
No reliable skin or eye irritation data are available for 3-(triethoxysilyl)propanethiol (CAS No. 14814-09-6, EC No. 238-883-1). Data are therefore read-across from the structural analogue 3-(trimethoxysilyl)propane-1-thiol (CAS 4420-74-0, EC No. 224-588-5).
In the key skin irritation study conducted in a manner equivalent or similar to OECD Test Guideline 404 (BRRC, 1990, GLP not specified, reliability score 2), the read-across substance 3-(trimethoxysilyl)propane-1-thiol was not irritating to the skin of New Zealand white rabbits.
In the key eye irritation study conducted in a manner equivalent or similar to OECD Test Guideline 405 (BRRC, 1990, GLP not specified, reliability score 2), the read-across substance 3-(trimethoxysilyl)propane-1-thiol was not irritating to the skin of New Zealand white rabbits.
See RAAF read-across justification in Section 13 (CSR Annex 4).
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:
- key study
- Study period:
- 1990/05/01
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- detailed summary report
- Justification for type of information:
- Read across based on close structural similarity between 3-(triethoxysilyl)propanethiol and the read-across substance 3-(trimethoxysilyl)propane-1-thiol, only difference being a triethoxy versus a trimethoxy group
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Not specified
- Age at study initiation: Not specified
- Weight at study initiation: 2-3 kg
- Housing: Not specified
- Diet: Commercial diet, ad libitum
- Water: Municipal water, ad libitum
- Acclimation period: Not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not specified
- Humidity (%): Not specified
- Air changes (per hr): Not specified
- Photoperiod (hrs dark / hrs light): Not specified - Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Remarks:
- intact skin
- 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:
- 14 days
- Number of animals:
- 3M, 3F
- Details on study design:
- TEST SITE
- Area of exposure: Not specified
- % coverage: Not specified
- Type of wrap if used: Occlusive, impervious sheeting
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Excess test item removed
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize - 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:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- 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:
- No erythema or oedema was observed in any animal at any time point.
- Other effects:
- None reported
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the key skin irritation study conducted in a manner equivalent or similar to OECD Test Guideline 404 (GLP not specified, reliability score 2), read-across substance 3-(trimethoxysilyl)propanethiol was not irritating to the skin of New Zealand white rabbits.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- detailed summary report
- Justification for type of information:
- Read across based on close structural similarity between 3-(triethoxysilyl)propanethiol and the read-across substance 3-(trimethoxysilyl)propane-1-thiol, only difference being a triethoxy versus a trimethoxy group
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Not specified
- Age at study initiation: Not specified
- Weight at study initiation: Not specified
- Housing: Not specified
- Diet): Commericial diet, ad libitum
- Water: Municipal water, ad libitum
- Acclimation period: Not specified
ENVIRONMENTAL CONDITIONS
- Not specified - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- Not clearly specified, eyelids held together for 1 second, scoring at 1, 4, 24, 48, 72 hours, and at 7 days
- Observation period (in vivo):
- Not clearly specified, scoring at 1, 4, 24, 48, 72 hours, and at 7 days
- Number of animals or in vitro replicates:
- 3M, 3F
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
SCORING SYSTEM
- Similar to OECD test guideline 405
TOOL USED TO ASSESS SCORE:
- Fluorescein staining used to determine corneal injury - 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 hours
- 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:
- positive 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:
- No corneal injury, iritis, or chemosis was observed in any of the eyes. Within one hour of application, minor transient conjunctival irritation (redness) was observed in 5/6 animals. All eyes were normal within 48 hours.
- Other effects:
- None reported.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the key eye irritation study conducted in a manner equivalent or similar to OECD Test Guideline 405 (GLP not specified, reliability score 2), read-across substance 3-(trimethoxysilyl)propanethiol was not irritating to the eyes of New Zealand white rabbits.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The key skin and eye irritation data are read across from the structural analogue 3-(trimethoxysilyl)propane-1-thiol, with supporting (reliability score 4) data available for 3-(triethoxysilyl)propanethiol.
In the key skin irritation study conducted in a manner equivalent or similar to OECD Test Guideline 404 (BRRC, 1990, GLP not specified, reliability score 2), undiluted 3-(trimethoxysilyl)propane-1-thiol) was applied at 0.5 ml to the intact (clipped) skin of six New Zealand white rabbits (three each sex) for 4 hours under an occlusive dressing. The dressings and excess material were then removed, and the skin reactions scored at 5, 24, 48, and 72 hours and at 7 days after application. None of the rabbits had any signs of skin irritation (all individual mean 24/48/72-hour erythema and edema scores were 0), and no other clinical signs of toxicity were observed. Under conditions of the study, the read-across substance 3-(trimethoxysilyl)propane-1-thiol) was not irritating to the skin of New Zealand white rabbits.
In the key eye irritation study conducted in a manner equivalent or similar to OECD Test Guideline 405 (BRRC, 1990, GLP not specified, reliability score 2), undiluted 3-(trimethoxysilyl)propane-1-thiol) was applied at 0.1 ml to the eyes of six New Zealand white rabbits (three each sex), with scoring at 1, 4, 24, 48, and 72 hours and at 7 days after application. No corneal injury, iritis, or chemosis was observed in any of the eyes. Within one hour minor transient conjunctival irritation (redness) was observed in 5/6 animals. However, except for one animal (mean 24/48/72-hour conjunctivae score of 0.33, normal within 48 hours), all individual mean 24/48/72-hour scores for this endpoint were 0. No other effects were reported. Under conditions of the study, the read-across substance 3-(trimethoxysilyl)propane-1-thiol) was not irritating to the eyes of New Zealand white rabbits.
In addition, two supporting non-guideline / non-GLP studies for skin and eye irritation are available for 3-(triethoxysilyl)propanethiol (Carnegie-Mellon Institute of Research, 1976). Grade 4 of 10 skin irritation and Grade 1 of 10 eye irritation was observed. However, the reliability of these studies is considered not assignable (reliability score 4) due insufficient documentation.
There are no specific studies of respiratory tract irritation. However, no irritation was reported in the acute inhalation study in rats (Carnegie-Mellon Institute of Research, 1976, reliability score 4).
Justification for classification or non-classification
Based on the lack of effects in the available data, as read across from the structurally analogous 3-(trimethoxysilyl)propane-1-thiol, no classification of 3-(triethoxysilyl)propanethiol is required for skin or eye irritation according to Regulation (EC) No. 1272/2008.
There are no data that indicate classification of 3-(triethoxysilyl)propanethiol as a respiratory irritant is required according to Regulation (EC) No. 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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