Registration Dossier

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
2000

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
No guideline is specified in the report.
GLP compliance:
no
Type of assay:
mammalian erythrocyte micronucleus test

Test material

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

Test animals

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
Water
Details on exposure:
The volume of administration was 10 mL/kg
Duration of treatment / exposure:
24 and 48 (control and high dose) or 72 (control and high dose) hours prior to sacrifice and preparation of the bone marrow.

Positive control animals were sacrificed at 24 hours after chlorambucil administration.
Frequency of treatment:
Single dose at 24 and 48 (control and high dose) or 72 (control and high dose) hours prior to sacrifice and preparation of the bone marrow.
Doses / concentrationsopen allclose all
Dose / conc.:
200 mg/kg bw (total dose)
Dose / conc.:
1 000 mg/kg bw (total dose)
Dose / conc.:
5 000 mg/kg bw (total dose)
No. of animals per sex per dose:
5 animals per sex per group
Control animals:
yes, concurrent vehicle
Positive control(s):
Chlorambucil (30 mg/ 10mL/kg)

Examinations

Tissues and cell types examined:
Bone marrow
Details of tissue and slide preparation:
On the Giemsa-stained slides, 1000 polychromatic erythrocytes per animal were examined for the presence of micronuclei.

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls validity:
not specified
Negative controls validity:
not examined
Positive controls validity:
valid
Additional information on results:
Balsalazide did not induce an increase of micronucleated polychromatic and normochromaic erythrocytes in mice bone marrow. In contrast, the % of micronucleated polychromatic erythrocytes in chlorambucil treated group was markedly higher than the negative control.

Applicant's summary and conclusion

Conclusions:
The test substance is not mutagenic in this test system.