Registration Dossier
Registration Dossier
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EC number: 236-828-6 | CAS number: 13501-76-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06.01.1997 to 10.01.1997
- 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 405 (Acute Eye 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 / tissue source
- Species:
- rabbit
- Strain:
- other: small white russian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: MØllegaard breeding & Research Centre Ltd
- Age at study initiation: No data
- Weight at study initiation: 2.3-2.5 kg
- Housing: Individual stainless steel
- 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: 06.01.1997 To 10.01.1997
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Duration of treatment / exposure:
- Single exposure
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eyes were flushed after treatment with fluorescein.
- Time after start of exposure: 24 hours
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: hand-slit lamp, fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No effects on the cornea
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: No effects on the iris
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No chemosis observed
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- Within one hour of instillation there was some redness and edema of the conjunctiva. By 24 and 48 hours after instillation there was some redness, but no edema. At 72 hours there were no signs of irritation remaining.
- Other effects:
- None reported.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In an eye irritation study conducted according to OECD 405 and to GLP, (3-chloropropyl)diethoxymethylsilane was only very slightly and transiently irritating to the eyes of small white Russian rabbits and therefore was not classified as an eye irritant.
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