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Registration Dossier
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EC number: 242-056-0 | CAS number: 18171-19-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 04.03.2002 to 30.07.2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (3-chloropropyl)dimethoxymethylsilane
- EC Number:
- 242-056-0
- EC Name:
- (3-chloropropyl)dimethoxymethylsilane
- Cas Number:
- 18171-19-2
- Molecular formula:
- C6H15ClO2Si
- IUPAC Name:
- (3-chloropropyl)dimethoxymethylsilane
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Laboratory of Pharmacology and Toxicology KG
- Age at study initiation: 6-6.5 months
- Weight at study initiation: 2.4 kg
- Housing: Singly in restrainers to prevent a body turn
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 20
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±3
- Humidity (%): 55± 15
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 09.04.2002 To: 20.04.2002
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
- Observation period:
- 72 hours
- Number of animals:
- Three
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2
- % coverage: No data
- Type of wrap if used: gauze patch held in place with a semi-occlusive dressing.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washing was not required.
SCORING SYSTEM: Draize and according to OECD TG 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- 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
- Max. score:
- 4
- 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:
- Grade 1 erythema was observed in one animal from 60 minutes to 24 hours after patch removal. There were no changes in the other two animals at any time point.
- Other effects:
- No other effects observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a skin irritation study, conducted according to OECD test guideline 404 and in compliance with GLP (reliability score 1), 3-chloropropyl(dimethoxy)methylsilane was not irritating to the skin of Himalayan rabbits. There were no systemic effects.
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