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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: study conducted by GLP accredited lab according to OECD guideline method 474

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1988

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals

Species:
mouse
Strain:
CF-1
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
distilled water
Details on exposure:
after dose finding study the maximum tolerated dose was determined to be 1000mg/kg
Duration of treatment / exposure:
72h
Frequency of treatment:
one single treatment at the beginng of the study
Post exposure period:
mice were killed at 24,48 and 72h after exposure
Doses / concentrations
Remarks:
Doses / Concentrations:
1000mg/kg
Basis:
actual ingested
No. of animals per sex per dose:
15
Control animals:
yes, concurrent vehicle
Positive control(s):
5 male and 5 female mice , 50mg/kg of cyclophosphamide

Examinations

Tissues and cell types examined:
bone marrow from femur
Details of tissue and slide preparation:
femur dissected and aspirated with foetal calf serum and bone marrow smears prepared following centrifugation and re-suspention. The smears were air-dried, fixed in absolute methanol and stained in May-Grunwald/Giemsa
Evaluation criteria:
stained bone marrow smears were examinated at random using light microscopy at 1000x magnification.

Results and discussion

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative