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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Specific investigations: other studies

Currently viewing:

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:
1988
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

Constituent 1
Chemical structure
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.

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.