Registration Dossier

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2006-02-22 to 2006-03-15
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

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

Test material

Constituent 1
Reference substance name:
476-99-6
IUPAC Name:
476-99-6

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
deionised water
Details on exposure:
substance formulated in vehicle
Duration of treatment / exposure:
animals received the test item once
Frequency of treatment:
once
Post exposure period:
24 h, 48 h
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
2000 mg/kg body weight
Basis:
actual ingested
Remarks:
Doses / Concentrations:
1000 mg/kg body weight
Basis:
actual ingested
Remarks:
Doses / Concentrations:
500 mg/kg body weight
Basis:
actual ingested
No. of animals per sex per dose:
main experiment:
high dose: 24 animals (12 males/12 females)
mid dose: 12 animals (6 males/6 females)
low dose: 12 animals (6 males/6 females)
Control animals:
yes, concurrent vehicle
Positive control(s):
Cyclophosphamide, 40 mg/kg b.w; 24 h;

Examinations

Tissues and cell types examined:
bone marrow cells; polychromatic erythrocytes; normochromatic erythrocytes
Details of tissue and slide preparation:
according guideline
Evaluation criteria:
standard
Statistics:
nonparametric Mann-Whitney test

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
yes
Remarks:
within 1 h after treatment with 2000 mg/kg b.w.
Vehicle controls validity:
valid
Negative controls validity:
not examined
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
Based on the experimental conditions reported the oral application of the substance to mice did not induce micronuclei as determined by the micronucleus test in the bone marrow cells (polychromatic erythrocytes).