Registration Dossier
Registration Dossier
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EC number: 201-126-0 | CAS number: 78-59-1
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Mutagenicity studies on ketone solvents: methyl ethyl ketone, methyl isobutyl ketone, and isophorone
- Author:
- O'Donoghue JL, Haworth SR, Curren RD, Kirby PE, Lawlor T, Moran EJ, Phillips RD, Putnam DL, Rogers-Back AM, Slesinski RS, Thilagar A
- Year:
- 1 988
- Bibliographic source:
- Mutat Res 206: 149-161
- Reference Type:
- other: OECD SIDS
- Title:
- 3,5,5-Trimethylcyclohex-2-enone (Isophorone), CAS No. 78-59-1
- Author:
- OECD SIDS
- Year:
- 2 003
- Bibliographic source:
- SIDS Initial Assessment Report for SIAM 16
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- not specified
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- 3,5,5-trimethylcyclohex-2-enone
- EC Number:
- 201-126-0
- EC Name:
- 3,5,5-trimethylcyclohex-2-enone
- Cas Number:
- 78-59-1
- Molecular formula:
- C9H14O
- IUPAC Name:
- 3,5,5-trimethylcyclohex-2-enone
- Details on test material:
- Purity ≥ 97%
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratory, Kingston, New York
- Age at study initiation: 6-8 weeks
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- corn oil
- Details on exposure:
- Single intraperitoneal application of 496.8 mg/kg of the test substance as mixture with vehicle in 10 mL/kg bw.
- Duration of treatment / exposure:
- 12, 24, 48 hours
- Frequency of treatment:
- single
- Post exposure period:
- none
Doses / concentrations
- Dose / conc.:
- 496.8 mg/kg bw/day (nominal)
- Remarks:
- = Maximum Tolerated Dose/LD20
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- triethylenemelamine
- Doses / concentrations: 0.25 mg/kg
Examinations
- Tissues and cell types examined:
- erythrocytes from femur bone marrow
- Details of tissue and slide preparation:
- Sampling times: 12, 24, 48 h post dosing.
Criteria for selection of Maximum Tolerated Dose (M.T.D.): LD20 (determined in a preliminary toxicity study) - Statistics:
- 1-way analysis of variance and Duncan's multiple range test (P <= 0.05)
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Remarks:
- Maximum Tolerated Dose (LD20) was applied
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
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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