Registration Dossier
Registration Dossier
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EC number: 221-338-7 | CAS number: 3069-40-7
Endpoint summary
Administrative data
Description of key information
In the key skin irritation study conducted according to OECD Test Guideline 404 but not in compliance with GLP (ASTA Pharma AG, 1987a) trimethoxy(octyl)silane was irritating to the skin of rabbits under occluded conditions. There were no systemic effects.
In the key eye irritation study conducted according to OECD Test Guideline 405 but not in compliance with GLP (ASTA Pharma AG, 1987b) trimethoxy(octyl)silane was not irritating to the eyes of rabbits. There were no systemic effects.
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:
- 13.07.1987 to 27.07.1987
- 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:
- no
- Species:
- rabbit
- Strain:
- other: white Russian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: ASTA Pharma AG, D-4800 Bielefeld 14
- Age at study initiation: 9-11 months
- Weight at study initiation: 2.2-2.45 kg
- Housing: Stainless steel cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): 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: 13.07.1987 to 27.07.1987 - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- Four hours
- Observation period:
- 14 days (observation times: 1, 24, 48 and 72 hours, then once daily
- Number of animals:
- Three
- Details on study design:
- TEST SITE
- Area of exposure: Dorsal skin
- % coverage: No data
- Type of wrap if used: Occlusive (linen cloth which adhered to a synthetic film glue, bandage wrapped several times around the trunk.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not mentioned, so assumed no washing
SCORING SYSTEM: Draize - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 4.9
- Max. score:
- 8
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- Erythema occurred in all three animals immediately after removal of the patches. The erythema was moderate to severe, but had disappeared by day 10 of observation. Edema also occurred immediately after the end of exposure; slight in one animal and moderate in two animals. The findings had disappeared by day 9. From the middle of the first observation week all animals showed eschar formation, which had not completely peeled off in two animals until the end of the observation period.
- Other effects:
- The general condition of the animals was not affected by the treatment.
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- In a skin irritation study conducted according to OECD Test Guideline 404 but not in compliance with GLP (reliability score 2) trimethoxyoctylsilane was irritating to the skin of rabbits. There were no systemic effects.
Reference
Table 1 summary of skin irritation results
| Skin reaction | Hours after end of exposure | Draize score | ||
| Animal 1 | Animal 2 | Animal 3 | ||
| Erythema and eschar formation | 1 | 1 | 1 | 2 |
| 24 | 3 | 2 | 3 | |
| 48 | 3 | 2 | 3 | |
| 72 | 3 | 3 | 3 | |
| Edema Formation | 1 | 2 | 2 | 2 |
| 24 | 3 | 2 | 3 | |
| 48 | 3 | 2 | 3 | |
| 72 | 3 | 2 | 3 | |
Mean value fotr erythema/eschar: 2.42
Mean value for edema: 2.5
Irritation index: 4.9
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:
- key study
- Study period:
- 14.07.1987 to 17.07.1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: white Russian (albino)
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: ASTA Pharma AG, D-4800 Bielefeld 14
- Age at study initiation: 5-6 months
- Weight at study initiation: 2.4 to 2.6 kg
- Housing: Individually in stainless steel cages
- Diet (e.g. ad libitum): Not stated, but assumed to be ad libitum
- Water (e.g. ad libitum): 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: 14.07.1987 to 17.07.1987 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- No rinsing
- Observation period (in vivo):
- Three days (1. 24. 48, 72 hours)
- Number of animals or in vitro replicates:
- Three (one male, two females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
SCORING SYSTEM: Draize scale
TOOL USED TO ASSESS SCORE: Cliptrix pencil light - Irritation parameter:
- other: Irritation index
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 4
- Max. score:
- 80
- Reversibility:
- fully reversible
- 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:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- 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:
- Cornea and iris did not show any findings. The conjunctiva reacted with hyperemia (grade 1) in one animal and in two animals diffuse crimson or beefy discolouration (grade 2 or 3) was observed. In addition, slight swelling (grade 1) or swelling with partial eversion of lids (grade 2) occurred. Swelling had completely disappeared at 24 hours and redness 48 or 96 hours after substance treatment. Discharge with moistening of considerable parts around the eye, was recorded in two animals only at observation time of one hour.
- Other effects:
- There were no systemic effects, and the general condition of the animals was undisturbed.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an eye irritation study conducted according to OECD Test Guideline 405 but not in compliance with GLP (reliability score 2) trimethoxyoctylsilane was not irritating to the eyes of rabbits. There were no systemic effects.
Reference
| Effect | Hours after exposure | Animal irritation scores | ||
| 1 | 2 | 3 | ||
| Corneal opacity | 1 | 0 | 0 | 0 |
| 24 | 0 | 0 | 0 | |
| 48 | 0 | 0 | 0 | |
| 72 | 0 | 0 | 0 | |
| Iritis | 1 | 0 | 0 | 0 |
| 24 | 0 | 0 | 0 | |
| 48 | 0 | 0 | 0 | |
| 72 | 0 | 0 | 0 | |
| Conjunctival redness | 1 | 1 | 2 | 3 |
| 24 | 1 | 1 | 2 | |
| 48 | 0 | 0 | 2 | |
| 72 | 0 | 0 | 0 | |
| Conjunctival chemosis | 1 | 1 | 2 | 2 |
| 24 | 0 | 0 | 0 | |
| 48 | 0 | 0 | 0 | |
| 72 | 0 | 0 | 0 | |
| Conjunctival discharge | 1 | 0 | 3 | 3 |
| 24 | 0 | 0 | 0 | |
| 48 | 0 | 0 | 0 | |
| 72 | 0 | 0 | 0 | |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In a skin irritation study conducted according to OECD Test Guideline 404 but not in compliance with GLP (reliability score 2) trimethoxy(octyl)silane was irritating to the skin of rabbits.
Erythema occurred in all three animals immediately after removal of the patches. The erythema was moderate to severe, but had disappeared by day 10 of observation. Edema also occurred immediately after the end of exposure; slight in one animal and moderate in two animals. The findings had disappeared by day 9. From the middle of the first observation week all animals showed eschar formation, which had not completely peeled off in two animals until the end of the observation period. The general condition of the animals was not affected by the treatment (ASTA Pharma AG, 1987a).
In an eye irritation study conducted according to OECD Test Guideline 405 but not in compliance with GLP (reliability score 2) trimethoxy(octyl)silane was not irritating to the eyes of rabbits. Cornea and iris did not show any findings. The conjunctiva reacted with hyperemia (grade 1) in one animal and in two animals diffuse crimson or beefy discolouration (grade 2 or 3) was observed. In addition, slight swelling (grade 1) or swelling with partial eversion of lids (grade 2) occurred. Swelling had completely disappeared at 24 hours and redness 48 or 96 hours after substance treatment. Discharge with moistening of considerable parts around the eye, was recorded in two animals only at observation time of one hour. There were no systemic effects, and the general condition of the animals was undisturbed (ASTA Pharma AG, 1987b).
Justification for classification or non-classification
Based on the available data, trimethoxy(octyl)silane is not classified for eye irritation according to Regulation (EC) No 1272/2008. Regarding skin irritation, the substance is classified as 'Cat 2: irritant', with the hazard statement 'H315: Causes skin irritation' according to Regulation (EC) No 1272/2008.
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