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Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Remarks:
This study is included in a NONS registration and therefore has been evaluated by a relevant competent authority and is considered to be reliable.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Annex V (Micronucleus)
GLP compliance:
yes
Type of assay:
other: micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
Corn oil
Details on exposure:
The dose of the test substance was judged to be the maximum attainable.
Duration of treatment / exposure:
Male: 5000 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 5000 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Male: 5000 mg/kg; No. of animals: 5; Sacrifice time: 72 hours
Female: 5000 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 5000 mg/kg; No. of animals: 5; Sacrifice times: 48 hours
Female: 5000 mg/kg; No. of animals: 5; Sacrifice times: 72 hours
Frequency of treatment:
Not specified
Post exposure period:
Not specified
Doses / concentrations
Dose / conc.:
5 000 mg/kg bw/day (nominal)
No. of animals per sex per dose:
15 male and 15 females
Control animals:
not specified
Positive control(s):
Cyclophosphamide

Examinations

Tissues and cell types examined:
Not specified
Evaluation criteria:
Micronucleus formation

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
no effects
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
No increase in micronucleus formation was observed. The positive control substance cyclophosphamide led to an increase in the incidence of micronuclei.
Toxicity: yes. Doses producing toxicity: Mitotic index: 5000 mg/kg; In a preliminary experiment 2 males and 2 females were treated with 5000 mg/kg of the test substance and exhibited a reduction in spontaneous activity.

Applicant's summary and conclusion

Conclusions:
The in vivo genetic toxicity of the test item was assessed in a micronucleus assay. The result was negative for the test item.
Executive summary:

The in vivo genetic toxicity of the test item was assessed in a micronucleus assay. The result was negative for the test item.

In vivo genetic toxicity was assessed in a micronucleus assay following a standard guideline. 15 male and female mice were exposed at a concentration of 5000 mg/kg, with 5 of each sex being sacrificed after 24, 48 and 72 hours. The study was negative, as no increase in micronucleus formation was observed.

In a preliminary experiment, 2 males and 2 females were treated with 5000 mg/kg of the test substance and exhibited a reduction in spontaneous activity.

The study is a GLP compliant, guideline experimental study and is acceptable with restrictions for assessment.