Registration Dossier

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
72 h
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study

Data source

Reference
Reference Type:
other: Provided by ECHA
Title:
Unnamed
Year:
1999

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
GLP compliance:
yes
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No data, but ECHA think it's identical with our substance.

Test animals

Species:
mouse
Strain:
ICR
Sex:
male/female
Details on test animals and environmental conditions:
no data

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
Corn oil
Details on exposure:
No data
Duration of treatment / exposure:
Male: 0 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 1250 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 2500 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 5000 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 0 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Male: 1250 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Male: 2500 mg/kg; No. of animaIs: 5; Sacrifice time: 48 hours
Male: 5000 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Male: 0 mg/kg; No. of animals: 5; Sacrifice !ime: 72 hours
Male: 1250 mg/kg; No. of animals: 5; Sacrifice time: 72 hours
Male: 2500 mg/kg; No. of animals: 5; Sacrifice time: 72 hours
Male: 5000 mg/kg; No. of animals: 5; Sacrifice time: 72 hours
Female: 0 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 1250 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 2500 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 5000 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 0 mg/kg; No. of animals: 5; Sacrifice times: 48 hours
Female: 1250 mg/kg; No. of animals: 5; Sacrifice times: 48 hours
Female: 2500 mg/kg; No. of animals: 5; Sacrifice times: 48 hours
Female: 5000 mg/kg; No. of animals: 5; Sacrifice times: 48 hours
Female: 0 mg/kg; No. of animals: 5; Sacrifice times: 72 hours
Female: 1250 mg/kg; No. of animals: 5; Sacrifice times: 72 hours
Female: 2500 mg/kg; No. of animals: 5; Sacrifice times: 72 hours
Female: 5000 mg/kg; No. of animals: 5; Sacrifice times: 72 hours
Frequency of treatment:
No data
Post exposure period:
No data
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
0 mg/kg
Basis:
no data
Remarks:
Doses / Concentrations:
1250 mg/kg
Basis:
no data
Remarks:
Doses / Concentrations:
2500 mg/kg
Basis:
no data
Remarks:
Doses / Concentrations:
5000 mg/kg
Basis:
no data
No. of animals per sex per dose:
5
Control animals:
yes, concurrent vehicle
Positive control(s):
No data

Examinations

Tissues and cell types examined:
Doses producing toxicity:
From a preliminary test, a maximum dose level of 5000 mg/kg was selected.
No animals died during the study. Clinical signs included lethargy which was observed in all animals at all dose levels on the days following dosing.

Slight reductions (up to 13%) in the ration of polychromatic erthrocytes to total erythrocytes were observed, these were within hislorical conlrol ranges.
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
Remarks:
No significant increases in the frequency of micronuclealed immalure erythrocytes were observed in groups of mice treated with the test substance.
Toxicity:
no effects
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative