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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Guideline:
other: Annex V (Micronucleus)
GLP compliance:
yes
Type of assay:
other: micronucleus assay

Test material

Constituent 1
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.