Registration Dossier

Administrative data

Endpoint:
carcinogenicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
significant methodological deficiencies

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984

Materials and methods

Test guideline
Qualifier:
no guideline followed
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
red powder
Specific details on test material used for the study:
tested in a complex mixture

Test animals

Species:
mouse

Administration / exposure

Route of administration:
dermal
Duration of treatment / exposure:
20 months

Results and discussion

Effect levels

Remarks on result:
other: no indication of causing skin or other tumours.

Applicant's summary and conclusion

Conclusions:
The study revealed no indication that Hydroxyethyl-2-nitro-p-toluidine, tested as part of non-oxidative hair dye formulation, might cause skin or other tumours in mice if dermally applied up to 20 months.