Registration Dossier

Administrative data

Endpoint:
in vivo mammalian germ cell study: gene mutation
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
publication
Title:
Final Report on the Safety Assessment of 2-Nitro-p-Phenylenediamine and 4-Nitro-o-Phenylenediamine
Author:
COSMETIC INGREDIENT REVIEW
Year:
1985
Bibliographic source:
JOURNAL OF THE AMERICAN COLLEGE OF TOXICOLOGY, Volume 4, Number 3, 1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Micronucleus Test in Rats
GLP compliance:
no
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of test material : 2 nitro p phenylenediamine (2NPPD)Substance type: OrganicPhysical state: Solid

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
No data

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
0.5 percent (w/v) gum tragacanthConcentration of test material in vehicle: 2000 mg/kg
Details on exposure:
No data
Duration of treatment / exposure:
48 hours and 6 hours observation
Frequency of treatment:
Twice
Post exposure period:
6 hours
Doses / concentrations
Remarks:
Doses / Concentrations:2000mg/kgBasis:no data
No. of animals per sex per dose:
5 rats/sex
Control animals:
not specified
Positive control(s):
no data

Examinations

Tissues and cell types examined:
bone marrow smears were examined.
Details of tissue and slide preparation:
no data
Evaluation criteria:
no data
Statistics:
no data

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
yes
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
RESULTS OF DEFINITIVE STUDYTypes of structural aberrations for significant dose levels (for Cytogenetic or SCE assay): No dataInduction of micronuclei (for Micronucleus assay): 2NPPD did not produce micronucleated polychromatic erythrocytes in ratsRatio of PCE/NCE (for Micronucleus assay): No dataAppropriateness of dose levels and route: No dataStatistical evaluation: No data

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negativeTwo doses of 2000 mg/kg 2NPPD in 0.5 percent (w/v) gum tragacanth given 24 hours apart were administered orally to groups of 5 male and 5 female rats. The rats were killed 6 hours after the second dose, and bone marrow smears were examined. 2NPPD did not produce micronucleated polychromatic erythrocytes in rats
Executive summary:

Two doses of2000mg/kg2NPPD in 0.5 percent (w/v) gum tragacanth given 24 hours apart was administered orally to groups of 5 male and 5 female rats. The rats were killed 6 hours after the second dose, and bone marrow smears were examined.

2NPPD resulted in the production of orange urine. Agitation, convulsions, and lethargy were observed in animals.

2NPPD did notproduce micronucleated polychromatic erythrocytes in rats.