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Registration Dossier
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EC number: 200-900-5 | CAS number: 75-77-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to an appropriate OECD test guideline. It was not compliant with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Chlorotrimethylsilane
- EC Number:
- 200-900-5
- EC Name:
- Chlorotrimethylsilane
- Cas Number:
- 75-77-4
- Molecular formula:
- C3H9ClSi
- IUPAC Name:
- chloro(trimethyl)silane
- Details on test material:
- No data
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hacking and Churchill Ltd.
- Age at study initiation: No data
- Weight at study initiation: 3.4-3.8 kg
- Housing: No data
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: No data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 40-60
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES:No data
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- 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:
- Up to 14 days where necessary.
- Number of animals:
- Three males
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: No data
- Type of wrap if used: NEEDS PROPER TRANSLATION
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with water
- Time after start of exposure: four hours
SCORING SYSTEM: Draize and OECD test guideline
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: up to 14 days
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: Not assessable due to necrosis.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: up to 7 days
- Reversibility:
- not reversible
- Remarks on result:
- other: Not assessable due to necrosis. Animal died on Day 10.
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: up to day 7
- Max. score:
- 0
- Remarks on result:
- other: No reaction observed
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: up to Day 14
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: Not assessable on Day 14 due to necrosis
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: up to Day 7
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- other: Animal died on Day 10
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: up to Day 7
- Max. score:
- 0
- Remarks on result:
- other: No reaction observed
- Irritant / corrosive response data:
- One of the animals did not have any skin reactions. Volatilisation or hydrolysis of product must be considered. A PROPER TRANSLATION IS REQUIRED.
- Other effects:
- One animal died after 10 days.
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In a well conducted skin irritation study (reliability score 2) conducted according to OECD test guideline 404 (GLP status not known) trimethylchlorosilane was corrosive to the skin of rabbits.
- Executive summary:
In a well conducted OECD 404 study, New Zealand white rabbits were exposed to 0.5 ml trimethylchlorosilane for four hours At the end of the exposure period excess test substance was washed off the skin with water. Skin reaction were then observed for up to 14 days. One animal died on Day 10, but had severe skin reactions, including corrosion, up to this point. One of the remaining animals had oedema, erythema and necrosis up to Day 14, although the reaction was often difficult to score due to the severity of the necrosis. The third animal did not have any reaction to the test substance, but this was considered to be an artefact, possibly due to evaporation of the test substance. Therefore trimethylsilane was considered to be corrosive to the skin of rabbits in this study.
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