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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:
experimental study
Adequacy of study:
key study
Study period:
March April 2005
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
GLP compliance:
yes (incl. QA statement)
Type of assay:
mammalian erythrocyte micronucleus test

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethyl 3-((1-(4-methylamino-3-nitrophenyl)methanoyl)pyridin-2-yl-amino)propionate
EC Number:
454-450-1
EC Name:
Ethyl 3-((1-(4-methylamino-3-nitrophenyl)methanoyl)pyridin-2-yl-amino)propionate
Cas Number:
429659-01-8
Molecular formula:
C18 H20 N4 O5
IUPAC Name:
ethyl 3-{1-[4-(methylamino)-3-nitrophenyl]-N-(pyridin-2-yl)formamido}propanoate
Test material form:
solid: particulate/powder

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
30% DMSO / 70%corn oil
Post exposure period:
24 h and 48 h
Doses / concentrationsopen allclose all
Dose / conc.:
500 mg/kg bw/day (actual dose received)
Remarks:
24 h preperation interval
Dose / conc.:
1 000 mg/kg bw/day (actual dose received)
Remarks:
24 h preparation interval
Dose / conc.:
2 000 mg/kg bw/day (actual dose received)
Remarks:
24 h preparation interval
Dose / conc.:
2 000 mg/kg bw/day (actual dose received)
Remarks:
48 h preparation interval
No. of animals per sex per dose:
24 h post treatment
Male: 500 mg/kg; No. of animals: 5
Male: 1000 mg/kg; No. of animals: 5
Male: 2000 mg/kg; No. of animals: 5
Female: 500 mg/kg; No. of animals: 5
Female: 1000 mg/kg; No. of animals: 5
Female: 2000 mg/kg; No. of animals: 5
48 h post-treatment
Male: 2000 mg/kg; No. of animals: 5
Female: 2000 mg/kg; No. of animals: 5
Control animals:
yes
Positive control(s):
Negative control
Male: No. of animals: 5
Female: No. of animals: 5
Positive control
Male: No. of animals: 5
Female: No. of animals: 5

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
yes
Remarks:
Doses producing toxicity: > 2000 mg/kg
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
It can be stated that under the experimental conditions reported, the test item did not induce micronuclei as determined by the micronucleus test with bone marrow cells of the mouse.
Therefore, BIBR 1048 Manamide is considered to be non-mutagenic in this micronucleus assay.