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
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
