Registration Dossier
Registration Dossier
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EC number: 205-087-0 | CAS number: 133-06-2
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 April - 2 May 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Captan
- EC Number:
- 205-087-0
- EC Name:
- Captan
- Cas Number:
- 133-06-2
- Molecular formula:
- C9H8Cl3NO2S
- IUPAC Name:
- 2-[(trichloromethyl)sulfanyl]-2,3,3a,4,7,7a-hexahydro-1H-isoindole-1,3-dione
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material: Merpan 80 WDG
- Active ingredient: Captan, N-(trichloromethylthio)cyclohex-4-ene-1,2-dicarboximide
- Appearance: off-white extruded granule
- Physical state: White crystalline solid
- Nominal content of a.i.: 80.8% (w/w)
- Measured content a.i.: 80.8% w/w
- Batch number: 91131140
- Sample expiry date: 3 June 2013
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- 0.5% carboxymethyl cellulose (CMC) and 0.5% acetic acid
- Duration of treatment / exposure:
- preliminary test: 72 hours; main study: 24 hours, 48 hours and 72 hours
- Frequency of treatment:
- once
Doses / concentrationsopen allclose all
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- Remarks:
- Main Study: one dose; actual ingested
- Dose / conc.:
- 200 mg/kg bw/day (actual dose received)
- Remarks:
- Main Study: one dose; actual ingested
- Dose / conc.:
- 40 mg/kg bw/day (actual dose received)
- Remarks:
- Main Study: one dose; actual ingested
- Dose / conc.:
- 5 000 mg/kg bw/day (actual dose received)
- Remarks:
- Preleminary Toxicity Test: one dose; actual ingested
- Dose / conc.:
- 2 500 mg/kg bw/day (actual dose received)
- Remarks:
- Preleminary Toxicity Test: one dose; actual ingested
- Dose / conc.:
- 100 mg/kg bw/day (actual dose received)
- Remarks:
- Preleminary Toxicity Test: one dose; actual ingested
- Dose / conc.:
- 250 mg/kg bw/day (actual dose received)
- Remarks:
- Preleminary Toxicity Test: one dose; actual ingested
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- Remarks:
- Preleminary Toxicity Test: one dose; actual ingested
- No. of animals per sex per dose:
- preliminary test: 2 male/2 female per dose (100, 250, 1000, 2500 and 5000 mg/kg)
main study: 5 male/5 female per dose (40, 200 mg/kg): 15 male/15 female per dose (1000 mg/kg); Chlorambucil 5 male/5 female (30 mg/kg) - Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Chlorambucil
Examinations
- Tissues and cell types examined:
- femurs, erythrocytes
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- No mutagenic activity under the conditions of this test was found.
- Executive summary:
The potential of captan to induce chromosomal damage was investigated by the micronucleus test. The procedures used complied with the recommendations of the OECD Guideline for Testing of Chemicals No. 474.
Charles River CD-I mice were orally administered captan suspended in 0.5% carboxymethyl cellulose (CMC) at dosages of 40, 200 and 1000 mg/kg at a constant volume-dosage of 10 ml/kg on Day 1. Dosages were selected on the basis of a preliminary toxicity test.
There was no increase in the frequency of micronucleated polychromatic cells in captan-treated groups, and no alteration in the ratio of polychromatic to nonnochromatic cells was apparent.
Chlorambucil, a known mutagen, used as a positive control, caused a significant increase in the frequency of micronucleated cells.
The test material, captan, was devoid of mutagenic activity under the conditions of this study.
The result is in accordance with several other in vivo tests on captan (e.g. Tezuka, H.).
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