Registration Dossier
Registration Dossier
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EC number: 619-753-7 | CAS number: 73611-02-6
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
- Study period:
- 30th May to 12th June 2003
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- OECD principles of Good Laboratory Practice for the testing of chemicals as specified by EU legislation
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- (1R, 4R, 5S) 4-hydroxy-6,6-dimethyl-3-Oxabicyclo[3.1.0]hexan-2-one
- EC Number:
- 619-753-7
- Cas Number:
- 73611-02-6
- Molecular formula:
- C7H10O3
- IUPAC Name:
- (1R, 4R, 5S) 4-hydroxy-6,6-dimethyl-3-Oxabicyclo[3.1.0]hexan-2-one
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- Swiss
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Duration of treatment / exposure:
- The test item was administered twice at 24 hour intervals by oral gavage
- Frequency of treatment:
- Twice every 24 hours
- Post exposure period:
- 24 hours
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
Low dose 40.52 ± 0.11 mg/ml
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
Mid dose 80.10 ± 0.40 mg/ml
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
High dose 159.0 ± 1.4 mg/ml
Basis:
actual ingested
- No. of animals per sex per dose:
- 2
- Control animals:
- yes
Examinations
- Tissues and cell types examined:
- From each animal a minimum of 2000 polychromatic erythrocytes (PCE's)were scored for the incidence of micronucleated PCE's. The ratio of PCE: total RBC was determined by counting 400 to 930 RCB's per animal.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
The study has shown that biocartol did not show evidence of mutagenic potential in Swiss albino mice at the doses tested. The test item exhibited clear evidence of cytotoxicity at and above a dose level of 200 mg/kg body weight under the conditions adopted.
Applicant's summary and conclusion
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
