Registration Dossier
Registration Dossier
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EC number: 202-599-6 | CAS number: 97-65-4
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:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 1 990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Itaconic acid
- EC Number:
- 202-599-6
- EC Name:
- Itaconic acid
- Cas Number:
- 97-65-4
- Molecular formula:
- C5H6O4
- IUPAC Name:
- 2-methylidenebutanedioic acid
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- Swiss
- Sex:
- not specified
Administration / exposure
- Route of administration:
- oral: unspecified
- Duration of treatment / exposure:
- Single oral dose of 1500 mg/kg
- Frequency of treatment:
- Single oral dose
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1500 mg/kg
Basis:
Examinations
- Tissues and cell types examined:
- Polychromatic erythrocytes
Results and discussion
Test results
- Sex:
- not specified
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Negative controls validity:
- valid
Any other information on results incl. tables
At the three sampling times the number of micronucleated polychromatic erythrocytes and the PE/NE ratio in mice treated with itaconic acid did not differ statistically from the concurrent negative control values. It is concluded that itaconic acid did not show any evidence of clastogenicity in the micronucleus test in mice.
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.
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