Registration Dossier
Registration Dossier
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EC number: 200-901-0 | CAS number: 75-78-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Dichloro(dimethyl)silane
- EC Number:
- 200-901-0
- EC Name:
- Dichloro(dimethyl)silane
- Cas Number:
- 75-78-5
- Molecular formula:
- C2H6Cl2Si
- IUPAC Name:
- dichlorodimethylsilane
- Details on test material:
- - Name of test material (as cited in study report): dimethyldichlorsilan
- Physical state: liquid
No further details available
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, UK
- Age at study initiation: No data (needs translation)
- Weight at study initiation: 3.7 kg
- Housing: No data
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: No data (needs translation)
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: November 1984
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:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: Flanks
- % coverage: No data (6 x 6cm)
- Type of wrap if used: Semiocclusive
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with water
- Time after start of exposure: four hours
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: skin induration and pale yellow or light-red bordered skin at the application site was observed at 24 and 48 hours; at 72 hours necrosis of the whole application site was observed.
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: skin induration and pale yellow or light-red bordered skin at the application site was observed at 24 and 48 hours; at 72 hours necrosis of the whole application site was observed.
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: skin induration and pale yellow or light-red bordered skin at the application site was observed at 24, 48 and 72 hours; day 4 necrosis of the whole application site was observed.
- Irritant / corrosive response data:
- Eschar formation observed.
- Other effects:
- Signs of corrosion were observed from 1 hour to 14 days.
Any other information on results incl. tables
Corrosion was reported rather than scores being given.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- In a well conducted skin irritation study (reliability score 2) comparable to OECD 404, but not to GLP, dichlorodimethylsilane was corrosive to rabbit skin.
- Executive summary:
In a well conducted skin irritation study (reliability score 2) comparable to OECD 404, but not to GLP, 0.5 ml undiluted dichlorodimethylsilane was applied to the shaved flanks of six New Zealand white rabbits under a semi-occlusive dressing for four hours. The application site was then washed with water, and the site assessed for signs of irritation for 14 days. Eschar formation was noted, as a result of the corrosive activity of the test substance.
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