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Registration Dossier
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EC number: 252-161-3 | CAS number: 34708-08-2
Endpoint summary
Administrative data
Description of key information
The key study for the skin irritation was performed according to OECD Test Guideline 404 but not in compliance with GLP (Asta-Werke AG, 1987a, reliability score 2). Triethoxy(3-thiocyanatopropyl)silane (CAS No. 34708-08-2, EC No. 252-161-3) had very slight irritant effects to the skin of rabbits, below the EU threshold for classification.
The key eye irritation study was conducted according to OECD Test Guideline 405 but not in compliance with GLP and found triethoxy(3-thiocyanatopropyl)silane to be a non-irritant when applied undiluted to the eyes of rabbits (Asta-Werke AG, 1987b, reliability score 2).
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:
- 13 January 1987 to 19 January 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- occlusive application (semi-occlusive recommended), temperature of 22 ± 2 °C (20 ± 3 °C recommended)
- Qualifier:
- according to guideline
- Guideline:
- other: 84/449/EEC
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: White Russian (Albino)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: ASTA-Werke AG, D-4800 Bielefeld 14
- Age at study initiation: 5 to 8 months
- Weight at study initiation: 2.20 to 2.45 kg
- Housing: singly in stainless tell cages type ASTA
- Diet: standard diet ad libitum
- Water: ad libitum
- Acclimation period: at least one day
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 13 January 1987 To: 30 January 1987 - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: one test patch and one untreated control patch was applied to the dorsal area of each animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- ~6 days (observation times: 1, 24, 48 and 72 hours after patch removal, and 6 days after application)
- Number of animals:
- 3M
- Details on study design:
- TEST SITE
- Area of exposure: 6.25 cm2
- % coverage: Not specified
- Type of wrap if used: Linen cloth secured by synthetic film glue, with an occlusive bandage wrapped around the trunk
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: no data
SCORING SYSTEM: Draize method (see "Any other information on materials and methods incl. tables") - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- no 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: 6 days
- 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 hours
- 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
- Irritant / corrosive response data:
- Two animals displayed erythema immediately after patch removal. One animal developed erythema 24 hours after patch removal. In all cases, erythema was grade one, except at 24 hours in one of the animals displaying an immediate reaction, when grade 2 erythema was observed. In each case, erythema was still visible at 72 hours, however, not at five days after patch removal.
Grade 1 oedema was seen in one animal 24 hours after patch removal. This was no longer visible 48 hours after patch removal. - Other effects:
- There was no evidence of systemic toxicity or mortality throughout the study.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a study conducted according to OECD Test Guideline 404 but not incompliance with GLP (reliability score 2), 0.5 mL of triethoxy(3-cyanatopropyl)silane was slightly irritating (by Draize criteria) to the skin of male rabbits when applied under occlusion for 4 hours. Mean individual 24/48/72-hour erythema scores were 1 to 1.3 (fully reversible within 6 days), with corresponding mean oedema scores of 0 to 0.33 (either no individual findings or, in one animal, fully reversible within 48 hours).
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
- Study period:
- 20 January 1987 to 29 January 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- temperature of 22 ± 2 °C (20 ± 3 °C recommended).
- Qualifier:
- according to guideline
- Guideline:
- other: 84/449/EEC
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: White Russian (Albino)
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: ASTA-Werke AG, D-4800 Bielefeld 14
- Age at study initiation: 6 to 7 months
- Weight at study initiation: 2.40 to 2.85 g
- Housing: singly in stainless steel cages type ASTA
- Diet: standard diet ad libitum
- Water: ad libitum
- Acclimation period: at least one day
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 20 January 1987 To: 23 January 1987 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: one eye of each animal left untreated
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- Applied on day 1
- Observation period (in vivo):
- 3 days (at 1, 24, 48 and 72 hours after application)
- Number of animals or in vitro replicates:
- 1M, 2F
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Draize system (see "Any other information on materials and methods incl. tables")
TOOL USED TO ASSESS SCORE: Cliptrix pencil light - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Remarks:
- sum of evaluation scores for three eye sections - mean over all timepoints
- Score:
- 2
- Max. score:
- 110
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: See "Any other information on materials and methods incl. tables" for information on derivation
- 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
- Remarks:
- redness
- 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
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- 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:
- No observable effects on the cornea or iris were observed.
Hyperaemia or redness (grade 1 or 2) was seen in the conjunctiva at 1 and 24 h after application. This was resolved within two days of application.
Slight swelling (grade 1) or swelling with partial eversion of lids (grade 2) each occurred in one animal within one hour of treatment and resolved within 24 hours.
Slight discharge was noted in one animal within one hour of application only. - Other effects:
- There were no overt signs of systemic toxicity or mortality over the duration of the study.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a study conducted according to OECD Test Guideline 405 but not in compliance with GLP (reliability score 2), triethoxy(3-thiocyanatopropyl)silane was non-irritating when 0.1 mL applied undiluted to the eyes of rabbits (one male, two females), with observations up to 72 hours. The mean individual 24/48/72-hour scores were 0 for the cornea, iris, and chemosis (all individual timepoint scores at 24-72 hours were 0). For conjunctival redness, the mean individual 24/48/72-hour scores were 0-0.66, and fully resolved in the two affected animals within 48 hours.
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 irritation study was conducted according to OECD Test Guideline 404 but not in compliance with GLP (Asta-Werke AG, 1987a, reliability score 2). The test material (0.5 mL) was noted to be slightly irritating to male rabbit skin following occlusive application for 4 hours. For the three rabbits, mean individual 24/48/72-hour erythema scores were 1 to 1.3 (fully reversible within 6 days), with corresponding mean oedema scores of 0 to 0.33 (either no individual findings or, in one animal, fully reversible within 48 hours). There were no signs of systemic toxicity or mortality throughout the study.
The key study for eye irritation of triethoxy(3-thiocyanatopropyl)silane was conducted according to OECD Test Guideline 405 but not in compliance with GLP (Asta-Werke AG, 1987b, reliability score 2). The test substance was non-irritating when 0.1 mL was applied undiluted to the eyes of rabbits (one male, two females), with observations up to 72 hours. The mean individual 24/48/72-hour scores were 0 for the cornea, iris, and chemosis (all individual timepoint scores at 24-72 hours were 0). For conjunctival redness, the mean individual 24/48/72-hour scores were 0-0.66, and fully resolved in the two affected animals within 48 hours. There were no overt signs of systemic toxicity or mortality throughout the course of the study.
There is no indication of corrosivity in any of the available studies.
Justification for classification or non-classification
Based on the available information, no classification is required for skin or eye irritation in accordance with Regulation (EC) No. 1272/2008.
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