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Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Type of information:
other: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
2003
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Justification for type of information:
Justification for Read Across is given in Section 13 of IUCLID

Data source

Reference
Reference Type:
secondary source
Title:
n-Butanol (CAS No. 71-36-3)
Author:
ECETOC
Year:
2003
Bibliographic source:
ECETOC JACC No. 41, ISSN-0773-6339-41, December 2003

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Deviations:
no
GLP compliance:
yes
Type of assay:
mammalian erythrocyte micronucleus test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 5 - 8 week

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
- Vehicle(s)/solvent(s) used: olive oil
Duration of treatment / exposure:
24 or 48 hours
Frequency of treatment:
Single oral application
Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/kg bw/day (nominal)
Dose / conc.:
500 mg/kg bw/day (nominal)
Dose / conc.:
1 000 mg/kg bw/day (nominal)
Dose / conc.:
2 000 mg/kg bw/day (nominal)
No. of animals per sex per dose:
No data
Control animals:
yes, concurrent vehicle

Examinations

Tissues and cell types examined:
Bone marrow

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
not examined
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified

Any other information on results incl. tables

No increase was noted in the number of normochromatic and polychromatic erythrocytes containing either small or large micronuclei and no inhibition or erythropoiesis or aneuploidy was detected.

Applicant's summary and conclusion

Conclusions:
Not mutagenic: no clastogenic effect in this test
Executive summary:

The substance was evaluated for its ability to induce mutagenicity in vivo, according to the OECD Guideline 474. Male and female NMRI mice were administered 0, 500, 1000 or 2000 mg/kg bw test item in olive oil by oral gavage, and animals were sacrificed after either 24 or 48 hours.

Bone marrow was then evaluated for any increase in the number of normochromatic and polychromatic erythrocytes containing either small or large micronuclei, and any inhibition or erythropoiesis or aneuploidy.

The test item did not lead to any increase in the number of polychromatic erythrocytes containing either small or large micronuclei. The rate of micronuclei was always in the same range as that of the negative control in all dose groups and at all sacrifice intervals. No inhibition of erythropoiesis determined from the ratio of polychromatic to normochromatic erythrocytes was detected. The test item, therefore, does not have any chromosome-damaging (clastogenic) effect, and there were no indications of any impairment of chromosome distribution in the course of mitosis.