Registration Dossier
Registration Dossier
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EC number: 204-442-7 | CAS number: 121-00-6
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:
- Data is from peer reviewed journal.
Data source
Reference
- Reference Type:
- publication
- Title:
- Final Report on the Safety Assessment of test substance
- Author:
- Cosmetic Ingredient Review Panel
- Year:
- 1 984
- Bibliographic source:
- International Journal of Toxicology, 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- An eye irritation study was condcuted to determine the adverse effects caused by the chemical six albino New Zealand rabbits.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2-tert-butyl-4-methoxyphenol
- EC Number:
- 204-442-7
- EC Name:
- 2-tert-butyl-4-methoxyphenol
- Cas Number:
- 121-00-6
- Molecular formula:
- C11H16O2
- IUPAC Name:
- 2-tert-butyl-4-methoxyphenol
- Test material form:
- solid: bulk
- Details on test material:
- - Name of test material: tert-butyl-4-methoxyphenol
- Common name: Phenol, (1,1-dimethylethyl)-4-methoxy-
- Molecular formula: C11H16O2
- Molecular weight: 180.2454 g/mol
- Smiles notation: COc1ccc(O)c(c1)C(C)(C)C
- InChI=1S/C11H16O2/c1-11(2,3)9-7-8(13-4)5-6-10(9)12/h5-7,12H,1-4H3
- Substance type: Organic
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- albino
Test system
- Vehicle:
- not specified
- Controls:
- yes
- Amount / concentration applied:
- 0.1ml
- Duration of treatment / exposure:
- 48 hours
- Observation period (in vivo):
- 24 and 48 hours
- Details on study design:
- Not specified
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24
- Score:
- 2
- Max. score:
- 110
- Reversibility:
- not specified
- Remarks on result:
- other: minimal or mild eye irritation in rabbits.
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 48
- Score:
- 0
- Max. score:
- 110
- Reversibility:
- not specified
- Irritant / corrosive response data:
- Minimal irritation was observed in treated rabbits.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- The test chemical was considered to be mildly irritating to the skin of treated albino rabbits.
- Executive summary:
The eye-irritating ability of a face powder containing 0.2 percent test chemical was studied in six albino New Zealand rabbits. The test material was instilled into one eye of each animal in a single 0.1 ml dose; the untreated eye of each rabbit served as control.
Average eye irritation scores 24 and 48 hours following exposure to the face powder were 2 and 0, respectively (the maximum possible score per observation was 110).
The author concluded the test chemical as minimal irritating to the eye of treated albino rabbits.
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