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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
carcinogenicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1984

Materials and methods

Principles of method if other than guideline:
The carcinogenicity of an oxidative hair dye formulation containing 0.01 of Picramic Acid was evaluated using random-bred Swiss-Webster mice (6 weeks old).
The experimental group and the two untreated control groups each contained 60 male and 60 female mice.
GLP compliance:
not specified

Test material

1
Chemical structure
Reference substance name:
2-amino-4,6-dinitrophenol
EC Number:
202-544-6
EC Name:
2-amino-4,6-dinitrophenol
Cas Number:
96-91-3
Molecular formula:
C6H5N3O5
IUPAC Name:
2-amino-4,6-dinitrophenol

Test animals

Species:
mouse
Strain:
Swiss Webster
Sex:
male/female
Details on test animals or test system and environmental conditions:
60 male and 60 female mice

Administration / exposure

Route of administration:
dermal
Details on exposure:
The dye was mixed with an equal volume of 6.0% H,O, and applied (0.05 mliapplication) once per week for a period of 20 months. Applications were made via a calibrated syringe to an area of skin, clipped free of hair, in the interscapular region.
Duration of treatment / exposure:
20 months
Doses / concentrations
Dose / conc.:
0.01 other: %

Results and discussion

Any other information on results incl. tables

Results from analyses of the blood and urine indicated no treatment-related effects. Pulmonary adenomas, hepatic hemangiomas,

and malignant lymphomas were observed in experimental and control groups.

Statistical analyses, chi-square, and Fisher exact tests, of the incidence of hepatic hemangiomas, pulmonary adenomas, and malignant lymphomas indicated no significant differences between experimental and control groups.

Applicant's summary and conclusion

Conclusions:
Results from analyses of the blood and urine indicated no treatment-related effects. Pulmonary adenomas, hepatic hemangiomas,
and malignant lymphomas were observed in experimental and control groups.
Statistical analyses, chi-square, and Fisher exact tests, of the incidence of hepatic hemangiomas, pulmonary adenomas, and malignant lymphomas indicated no significant differences between experimental and control groups.
Executive summary:

The carcinogenicity of an oxidative hair dye formulation containing 0.01 % of Picramic Acid was evaluated using random-bred Swiss-Webster mice during 20 months.

The experimental group and the two untreated control groups each contained 60 male and 60 female mice.

Results from analyses of the blood and urine indicated no treatment-related effects. Pulmonary adenomas, hepatic hemangiomas,

and malignant lymphomas were observed in experimental and control groups.

Statistical analyses, chi-square, and Fisher exact tests, of the incidence of hepatic hemangiomas, pulmonary adenomas, and malignant lymphomas indicated no significant differences between experimental and control groups.