Registration Dossier
Registration Dossier
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EC number: 238-339-3 | CAS number: 14367-46-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data is from peer reviewed journals
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- MAK Value Documentation in German language, 2001
- Author:
- The MAK Collection for Occupational Health and Safety
- Year:
- 2 001
- Bibliographic source:
- The MAK Collection for Occupational Health and Safety, 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- A study was conducted to evaluate the eye irritation potential of the test chemical according to OECD guideline 405 in rabbits
- GLP compliance:
- not specified
Test material
- Reference substance name:
- p-anisidine
- EC Number:
- 203-254-2
- EC Name:
- p-anisidine
- Cas Number:
- 104-94-9
- Molecular formula:
- C7H9NO
- IUPAC Name:
- p-Anisidine
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): p-anisidine
- IUPAC Name: 4-methoxyaniline
- Molecular Formula: C7H9NO
- Molecular Weight: 123.15 g/mol
- Substance type: Organic
- Physical state: Solid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Not reported
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- Not reported
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 24 hours
- Number of animals or in vitro replicates:
- Not reported
- Details on study design:
- Not reported
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24 h
- Reversibility:
- other: Without irreversible effects
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- Signs of irritation was observed, without irreversible effects
- Other effects:
- Not reported
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- In a study by OECD Guideline 405, the test chemical after 24 hours of exposure was irritating to the rabbit eye without irreversible effects.
- Executive summary:
A study was conducted to evaluate the eye irritation potential of the test chemical according to OECD guideline 405 in rabbits
The test chemical was applied to rabbit eyes and after 24 hours of dosing effects were observed.
The test chemical after 24 hours of exposure was irritating to the rabbit eye without irreversible effects.
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