Registration Dossier
Registration Dossier
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EC number: 202-430-6 | CAS number: 95-54-5
Specific investigations: other studies
Administrative data
- Endpoint:
- cytotoxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
- Remarks:
- Non-guideline study. Limited information on methods.
Data source
Reference
- Reference Type:
- publication
- Title:
- In vitro study of the cross-sensitivity of hair dye using hapten-specific lymphocytes
- Author:
- Shigematsu T, Ozawa N, Nakayama H
- Year:
- 1 988
- Bibliographic source:
- Contact Dermatis 19:30-35
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- GLP compliance:
- not specified
- Type of method:
- in vitro
Test material
- Reference substance name:
- o-phenylenediamine
- EC Number:
- 202-430-6
- EC Name:
- o-phenylenediamine
- Cas Number:
- 95-54-5
- Molecular formula:
- C6H8N2
- IUPAC Name:
- benzene-1,2-diamine
- Details on test material:
- Provided by Wako Pure Chemical Industries.
Constituent 1
Test animals
- Species:
- guinea pig
- Strain:
- other: Inbred strain JY-1
- Sex:
- male/female
Administration / exposure
- Details on study design:
- The epidermal cell suspension required were prepared by the Kitano and Okada method (Kitano and Okada, 1983).
Epidermal cells were cultured in Falcon plastic dishes for 24 hours. The test compound was then added at a concentration of 1 to 50 ppm/ml, followed by a 48 hour incubation. The cells were stained by the Giemsa method.
Cytotoxicity of the target cells was measured by the tryptan blue assay.
Results and discussion
- Details on results:
- At 1, 2, 5, 10 ppm there was complete survival of adherent cells (no difference from control.) At 20 ppm, the number of adherent cells was shown to be decreased by 10% to 20% compared with control. It is suggested that this assay is an excellent in vitro model of contact hypersensitivity.
Applicant's summary and conclusion
- Conclusions:
- At 1, 2, 5, 10 ppm there was complete survival of adherent cells (no difference from control.) At 20 ppm, the number of adherent cells was shown to be decreased by 10% to 20% compared with control.
- Executive summary:
At 1, 2, 5, 10 ppm there was complete survival of adherent cells (no difference from control.) At 20 ppm, the number of adherent cells was shown to be decreased by 10% to 20% compared with control.
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