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Toxicological information

Specific investigations: other studies

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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:
1988
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

Constituent 1
Chemical structure
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

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