Registration Dossier
Registration Dossier
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EC number: 236-112-3 | CAS number: 13170-23-5
Toxicological information
Skin irritation / corrosion
Currently viewing:
Administrative data
- Endpoint:
- skin irritation: in vivo
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05.08.1988 to 14.12.1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Three minute exposure, but this is acceptable in light of the severity of the findings. No test substance purity.
- GLP compliance:
- yes
Test material
- Reference substance name:
- triacetoxy(ethyl)silane
- IUPAC Name:
- triacetoxy(ethyl)silane
Constituent 1
Test animals
- 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: 2.4-2.7 kg
- Housing: Individual in polystyrene cages
- Diet (e.g. ad libitum): 150 g per animal per day
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least seven days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5-23
- Humidity (%): 38-75
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 07.09.1989 To: 21.09.1989
Test system
- Type of coverage:
- semiocclusive
- 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:
- 3 minutes
- Observation period:
- 14 days
- Number of animals:
- Six males
- Details on study design:
- TEST SITE
- Area of exposure: Back and flanks
- % coverage: No data
- Type of wrap if used: Semi-occlusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Equivalent to Draize.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.6
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: Some burning noticed from 24 hours. Grade 4 erythema by Day 7 and still apparent on Day 14. Burning and dryness on Day 14.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: By Day 14 there was no erythema, but there was dryness and desquamation. Burns observed.
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: By Day 14 there was still grade 4 erythema, burns, dryness and desquamation. Burns observed.
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: On Day 14 there was desquamation and dryness.
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: On Day 14 there was Grade 1 erythema, burns, desquamation and dryness. Burns observed.
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: On Day 14 there was Grade 1 erythema, dryness and desquamation. Burns observed.
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days.
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days.
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours.
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days.
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days.
- Irritant / corrosive response data:
- Grade 2 erythema and edema were observed in all animals within the first hour after dressing removal. The overall reactions peaked between 24 and 48 hours after dressing removal. By 72 hours the edema began to reverse in all of the animals. However, erythema persisted for longer, such that two of the animals still had Grade 4 erythema on Day 14. Burns of varying sizes (as a proportion of the initial test area) were observed in five of the six exposed animals.
- Other effects:
- None
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Conclusions:
- In a non-guideline study that was comparable to OECD 404 and in compliance with GLP, triacetoxyethylsilane was corrosive to the skin of rabbits. In this study the skin was exposed under semi-occlusive conditions for three minutes. Although this exposure period does not comply with current guidelines, it was long enough to show the corrosive nature of the test substance and the study is therefore considered to be reliable (reliability score 1; reliability score 2 as read-across study). Grade 2 erythema and edema were observed in all animals within the first hour after dressing removal. The overall reactions peaked between 24 and 48 hours after dressing removal. By 72 hours the edema began to reverse in all of the animals. However, erythema persisted for longer, such that two of the animals still had Grade 4 erythema on Day 14. Burns of varying sizes (as a proportion of the test site) were observed in five of the six exposed animals.
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