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Toxicological information

Genetic toxicity: in vivo

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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:
1993

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
Chemical structure
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%

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