Registration Dossier
Registration Dossier
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EC number: 203-584-7 | CAS number: 108-45-2
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 and results. No purity information on test compound.
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 Dermatitis, 19:30-35
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The cytotoxicity of the test compound was assessed using an in vitro assay with guinea pig epidermal cells
- GLP compliance:
- not specified
- Type of method:
- in vitro
Test material
- Reference substance name:
- m-phenylenediamine
- EC Number:
- 203-584-7
- EC Name:
- m-phenylenediamine
- Cas Number:
- 108-45-2
- Molecular formula:
- C6H8N2
- IUPAC Name:
- m-phenylenediamine
- 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
- Details on test animals or test system and environmental conditions:
- Guinea pigs were bred at the Institute of Shizuko Experimental Animals, Japan.
Weight: 300-400 g
Diet: Pellet diet
Administration / exposure
- Details on exposure:
- In vitro Cytotoxicity Experiment
Epidermal cells isolated from guinea pigs were cultured in Falcon plastic dishes for 24 hours. Each chemical was then added at a concentration of 1 to 50 ppm/ml for 48 hrs incubation. The cells were stained by the Giemsa method. - Analytical verification of doses or concentrations:
- not specified
Results and discussion
- Details on results:
- In vitro:
1, 2, 5 and 10 ppm-Complete survival of adherent cells (no difference from control).
20 ppm-The number of adherent cells was shown to be decreased by between 10% and 20% compared with control.
Applicant's summary and conclusion
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