Registration Dossier
Registration Dossier
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EC number: 202-431-1 | CAS number: 95-55-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- publication
- Title:
- Two-stage bottom-up tiered approach combining several alternatives for identification of eye irritation potential of chemicals including insoluble or volatile substances
- Author:
- Hayashi et al
- Year:
- 2 012
- Bibliographic source:
- Toxicology in Vitro 26 (2012) 1199–1208
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Deviations:
- yes
- Remarks:
- The exposure time is 90 minutes instead of 30 minutes
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2-aminophenol
- EC Number:
- 202-431-1
- EC Name:
- 2-aminophenol
- Cas Number:
- 95-55-6
- Molecular formula:
- C6H7NO
- IUPAC Name:
- 2-aminophenol
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- purchased from Sigma Aldrich Co. (St. Louis, MO, USA)
Test animals / tissue source
- Species:
- other: EpiOcular OCL-200
- Details on test animals or tissues and environmental conditions:
- purchased from MatTek Corporation (Ashland, MA, USA)
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 50 mg/tissue
- Duration of treatment / exposure:
- 90 minutes
- Duration of post- treatment incubation (in vitro):
- 18h
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- After treatment, tissues were rinsed by dipping, swirling and decanting three times with DPBS
Viability was determined by the MTT assay.
A viability of less than 60% identifies a substance as an eye irritant.
The publication lists results of in-vitro assays for 56 substances of known in-vivo eye irritant potential. Individual OD scores and control incubations are not provided.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Remarks:
- % viability
- Run / experiment:
- mean
- Value:
- 72.6
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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