Registration Dossier
Registration Dossier
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EC number: 203-251-6 | CAS number: 104-91-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Historical animal data is provided in a review of nitro-phenols.
The testing listed was performed in 1977
Animal data suggest classification as Skin Irrit 2
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Concise International Chemical Assessment Document 20
- Author:
- World Health Organisation
- Year:
- 2 000
- Bibliographic source:
- International Programme on Chemical Safety, Concise International Chemical Assessment Document 20
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 4-nitrophenol
- EC Number:
- 202-811-7
- EC Name:
- 4-nitrophenol
- Cas Number:
- 100-02-7
- Molecular formula:
- C6H5NO3
- IUPAC Name:
- 4-Nitrophenol
- Test material form:
- solid: crystalline
Constituent 1
- Specific details on test material used for the study:
- Not specified in the review
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- Two tests are reported; one was applied as 10% in water and one neat
- Duration of treatment / exposure:
- Assumed 24 hours
- Observation period (in vivo):
- At least 72 hours
- Number of animals or in vitro replicates:
- Not specified in the review
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- animal: mean score
- Time point:
- 24/48/72 h
- Score:
- 6
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Few details specified in the review, but conclusion was irritating and not causing eye damage
- Other effects:
- Not specified in the review
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Classified in Annex VI of CLP as Eye Dam 1
No evidence has been found to support this classification
Two studies are cited in the review with one causing no irritation to rabbits when applied dilute, but moderate irritation when applied undiluted
The scoring system used is unclear, but the conclusion is that on the basis of the data presented, the substance is irritating to eyes
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