Registration Dossier
Registration Dossier
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EC number: 236-671-3 | CAS number: 13463-41-7
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:
- 2 001
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:
- Pyrithione zinc
- EC Number:
- 236-671-3
- EC Name:
- Pyrithione zinc
- Cas Number:
- 13463-41-7
- Molecular formula:
- C10H8N2O2S2Zn
- IUPAC Name:
- Bis [1-hydroxy-2(1H)-pyridinethionato-O,S](T-4)-zinc
- Details on test material:
- Purity: 97.9%
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: Crl:NMRIBR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Source: Charles River WIGA GmbH
Age at study initiation: 9 weeks
Weigth at study initiation: male 29.0-33.7g female 24.8-29.9g
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- carboxymethylcellulose (0.5% aq)
- Details on exposure:
- Application volume: 10 ml/kg bw
- Frequency of treatment:
- 1
- Post exposure period:
- 24 + 48h
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
80mg/ml
Basis:
- Remarks:
- Doses / Concentrations:
100 mg/ml
Basis:
- Remarks:
- Doses / Concentrations:
130 mg/ml
Basis:
- No. of animals per sex per dose:
- 5
- Positive control(s):
- cyclophophamide (monohydrate) 40 mg/kg bw
Examinations
- Tissues and cell types examined:
- Tissue: bone marrow
Cell type: polychromatic erythrocytes - Details of tissue and slide preparation:
- 2000 polychromatic erythrocytes/animal
- Evaluation criteria:
- Polychromatic/normochromatic erythrocytes ratio
Micronucleated erythrocytes
Results and discussion
- Additional information on results:
- Clinical signs: Sedation, reduced locomotion, exsiccation, generally weak condition: high dose group animals.
Mortality: High dose: 6/15 males, 2/15 females (spare animals included) Mid dose: 1/5 males, 2/5 females.
Haematology/tissue examination: Amount of nucleated cells and/or of polychromatic erythrocytes reduced 24 and/or 48 h after treatment in all dose groups.
Applicant's summary and conclusion
- Conclusions:
- The test substance does not produce relevant increases of the numbers of micronuclei in polychromatic erythrocytes after in vivo treatment of mice of either sex of the test strain at doses of 800, 1000 and 1300 mg/kg bw. This information may not be used for any purpose other than in support of the Chemical safety Report submitted by Arch Chemicals Inc. under Regulation EC 1907/2006.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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