Registration Dossier
Registration Dossier
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EC number: 231-820-9 | CAS number: 7757-82-6
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian germ cell study: cytogenicity / chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Literature data
Data source
Reference
- Reference Type:
- publication
- Title:
- Mutagenicity of cosmetics ingredients licensed by the European Communities
- Author:
- Gocke E., King M.-T., Eckhardt K. and Wild D.
- Year:
- 1 981
- Bibliographic source:
- Mutation Research, 90 (1981) 91-109
Materials and methods
- Principles of method if other than guideline:
- The micronucleus test was performed according to Schmid (1976). The animals were treated at 0 and 24 h and bone-marrow smears were prepared at 30 h. 4 mice (2 male, 2 female) were used for each of 3 doses and 1 control. Slides were coded, and 1000 polychromatic erythrocytes were scored per mouse.
- GLP compliance:
- not specified
- Type of assay:
- chromosome aberration assay
Test material
- Reference substance name:
- Similar Substance 01
- IUPAC Name:
- Similar Substance 01
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: S. Ivanovas GmbH and Co., Kisslegg/Allgau (Germany)
- Diet: standard, Altromin GmbH, Lage, Germany
- Water: ad libitum
Administration / exposure
- Route of administration:
- intraperitoneal
- Duration of treatment / exposure:
- 0 to 24 hours
- Post exposure period:
- Bone-marrow smears were prepared at 30 h.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 2x28.8, 2x57.8, 2x86.3 mg/kg
Basis:
nominal conc.
- No. of animals per sex per dose:
- 4 mice (2 male, 2 female) were used for each of 3 doses and 1 control.
Examinations
- Tissues and cell types examined:
- Micronucleus test on mouse bone marrow.
- Details of tissue and slide preparation:
- Slides were coded and 1000 polychromatic erythrocytes were scored per mouse.
- Statistics:
- Significance was calculated according to the Kastenbaum-Bowman tables
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- not examined
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
Non-mutagen - Executive summary:
As part of an investigation into mutagenic effects of environmental compounds, three systems were used to evaluate the genetic toxicity of substances: the Sahnonella/microsome test, the Basc test on Drosophila and the micronucleus test on mouse bone marrow.
Result
Non-mutagen
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