Registration Dossier
Registration Dossier
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EC number: 224-221-9 | CAS number: 4253-34-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03.10.1989 to 17.01.1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Methylsilanetriyl triacetate
- EC Number:
- 224-221-9
- EC Name:
- Methylsilanetriyl triacetate
- Cas Number:
- 4253-34-3
- Molecular formula:
- C7H12O6Si
- IUPAC Name:
- methylsilanetriyl triacetate
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 to 2.6 kg
- Housing: Individually in polystyrene cages
- Diet (e.g. ad libitum): 150 g/animal/day
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 8 days before treatment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20± 3
- Humidity (%): 30-70
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 03.10.1989 To: 17.10.1989
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:
- Four hours
- Observation period:
- 14 days
- Number of animals:
- Three
- Details on study design:
- TEST SITE
- Area of exposure: Flanks
- % coverage: No data
- Type of wrap if used: Semi-occlusive
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No done
SCORING SYSTEM: Equivalent to Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Grade 4 erythema was observed on Day 14 for animal No. 1. Burns developed by 72 hours and remained on Day 14.
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Grade 2 edema was observed for animal No 1, which was fully reversible within 14 days.
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Burns developed immediately, and were replaced by eschar by Day 14 for animal No 2.
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Grade 1 edema was observed for animal No 2, which was fully reversible within 72 hours.
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Burns developed immediately, and were replaced by eschar by Day 14 for animal No 3.
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Grade 2.33 edema was observed for animal No 3, which was fully reversible within 14 days.
- Irritant / corrosive response data:
- Severe erythema (Grade 4) still apparent at 14 day observation, with necrosis. Max Grade 3 oedema, resolved by Day 14.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1C (corrosive) based on GHS criteria
- Conclusions:
- In a skin irritation/corrosion study conducted according to OECD TG 404 and in compliance with GLP (reliability score 1) methylsilanetriyl triacetate was corrosive to the skin of rabbits. Severe erythema (Grade 4) was still apparent at the 14 day observation point, with necrosis. Maximum Grade 3 oedema was resolved by Day 14 in all animals.
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