Registration Dossier
Registration Dossier
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EC number: 204-352-8 | CAS number: 119-80-2
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
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
- Reference substance name:
- 2,2'-dithiodi(benzoic acid)
- EC Number:
- 204-352-8
- EC Name:
- 2,2'-dithiodi(benzoic acid)
- Cas Number:
- 119-80-2
- Molecular formula:
- C14H10O4S2
- IUPAC Name:
- 2-[(2-carboxyphenyl)disulfanyl]benzoic acid
- Test material form:
- other: Solid
- Details on test material:
- The test material had a purity of 75.7%
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- Corn oil
- Duration of treatment / exposure:
- Not applicable
- Frequency of treatment:
- Single dose
- Post exposure period:
- 24 and 48 hours
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1250 mg/kg
Basis:
actual ingested
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide
- Route of administration: Oral gavage
- Doses / concentrations: 65 mg/kg
Examinations
- Tissues and cell types examined:
- Bone marrow from one femur
- Details of tissue and slide preparation:
- 1000 polychromatic erythrocytes were examined for the precense of micronuclei
- Statistics:
- All analyses were carried out using the GLM procedure in SAS (1989)
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Adverse reactions to treatment were observed in both male and females. Two males and two females were found dead on the day of dosing. Additional animals were dosed to replace those that died prior to their scheduled termination.
Small decreases were observed in the % of polychromatic erythrocytes in the dosed females compared to vehicle controls. The decrease achieved statistical significance at the 48 hr sampling time. However these small decreases are considered not to be of biological significance due to teh variation in the values observed between animals.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
DTBA was negative in the in vivo micronucleus assay
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