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EC number: 617-116-8 | CAS number: 80573-04-2
Genetic toxicity: in vivo
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:
- 2 000
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 substance name:
- Benzoic acid, 5-[(1E)-[4-[[(2-carboxyethyl)amino]carbonyl]phenyl]azo]-2- hydroxy-, disodium salt, dihydrate
- Cas Number:
- 150399-21-6
- Molecular formula:
- C17H13N3O6Na2 . 2H2O
- IUPAC Name:
- Benzoic acid, 5-[(1E)-[4-[[(2-carboxyethyl)amino]carbonyl]phenyl]azo]-2- hydroxy-, disodium salt, dihydrate
- Test material form:
- solid
Constituent 1
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.
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