Registration Dossier

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Secondary source peer reviewed literature data. Limited information is available, however the study was conducted in accordance with OCED guidelines.

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Deviations:
not specified
GLP compliance:
not specified
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name: 2-(1-Methylpropyl)-4,6-dinitrophenol
CAS: 88-85-7
Purity: 96.9%

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain: Hoe:NMRkf (SPF71)
- Weight at study initiation: 24 to 38 g

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
- Vehicle(s)/solvent(s) used: 2% starch slurry
- Concentration of test material in vehicle: 2%
Details on exposure:
no data
Duration of treatment / exposure:
The bone marrow was processed 24, 48 and 72 hours after dosing.
Frequency of treatment:
no data
Post exposure period:
no data
Doses / concentrations
Remarks:
Doses / Concentrations:
10, 25 and 40 mg/kg body weight
Basis:
no data
No. of animals per sex per dose:
5 males & 5 females
Control animals:
yes
Positive control(s):
Cyclophosphamide
- Doses / concentrations: 50 mg kg body weight

Examinations

Tissues and cell types examined:
- polychromatic to normochromatic erythrocytes
- micronuclei
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:
not specified
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
There was no increase in the occurrence of micronuclei compared with the negative controls. The ratio of polychromatic to normochromatic erythrocytes was unaffected.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
The substance was not mutagenic in this study.
Executive summary:

A review article published in 1997 by BG Chemie states that in a micronucleus test (in accordance with OECD guideline No. 474), 5 male and 5 female NMRI mice (strain Hoe: NMRkf (SPF71); weight 24 to 38 g) were given the test substance (technical product, 96.9% pure) orally in a 2% starch slurry at doses of 0 (negative controls), 10, 25 and 40 mg/kg body weight, Positive controls were treated with 50 mg cyclophosphamide/kg body weight. The bone marrow was processed 24, 48 and 72 hours after dosing. There was no increase in the occurrence of micronuclei compared with the negative controls. The ratio of polychromatic to normochromatic erythrocytes was unaffected. Thus the substance was not mutagenic in this study.