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Registration Dossier
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EC number: 236-828-6 | CAS number: 13501-76-3
Toxicological information
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30.09.1996 to 15.10.1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
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)
- Remarks:
- Ministerium für Umwelt, Raumordnung und Landwirtschaft des Landes Nordrhein-Westfalen
Test material
- Reference substance name:
- (3-chloropropyl)diethoxymethylsilane
- EC Number:
- 236-828-6
- EC Name:
- (3-chloropropyl)diethoxymethylsilane
- Cas Number:
- 13501-76-3
- Molecular formula:
- C8H19ClO2Si
- IUPAC Name:
- (3-chloropropyl)(diethoxymethyl)silane; (3-chloropropyl)diethoxymethylsilane; (4-chloro-1,1-diethoxybutyl)silane
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: small white Russian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: MØllegaard Breeding/Research Centre Ltd
- Age at study initiation: 'adult'
- Weight at study initiation: 2.2-2.7 kg
- Housing: Individual in stainless steel cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±3
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 30.09.1996 To: 15.10. 1996
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- 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:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: Dorsal trunk
- % coverage: No data
- Type of wrap if used: Semi-occlusive
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, with warm 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:
- other: mean over 24, 48 and 72 h
- Score:
- 2.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritant / corrosive response data:
- 30-60 minutes after removal of the dressings two rabbits had grade 2 erythema and edema, and one had grade 1 erythema and edema. After 24 and 48 hours the irritation had worsened so that the erythma was grade 2 and 3 and the edema was grade 2 and 4. The irritation then gradually reversed until there were no signs of erythema and edema on Day 10.
- Other effects:
- Yellow skin discolouration in animal 1 after 24 and 48 hours was observed. Dry or flaky skin in all animals after about a week was also observed. There were signs of irritation beyond the exposure area in animal 1 at 24, 48 and 72 hours. There was no scarring in any of the animals. There were no signs of irritation by Day 14.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In a skin irritation study conducted according to OECD 404 and to GLP, (3-chloropropyl)diethoxymethylsilane was irritating to the skin of small white Russian rabbits.
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