Registration Dossier
Registration Dossier
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EC number: 208-782-7 | CAS number: 541-47-9
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:
- other information
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP declaration, sufficient information given
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Guideline for testing of chemicals 474, 1983, Genetic Toxicology, Micronucleus -Test
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 3-methylcrotonic acid
- EC Number:
- 208-782-7
- EC Name:
- 3-methylcrotonic acid
- Cas Number:
- 541-47-9
- Molecular formula:
- C5H8O2
- IUPAC Name:
- 3-methylbut-2-enoic acid
- Test material form:
- solid: crystalline
- Details on test material:
- Purity: 98,7 % ,light yellow cristals
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- water: tap water in plastic bottles ad libitum, ID: KMno4 plus numbering of cages, 5 animals per sex , NMRI mice, relative humidity: 55+/- 10% , Light time period: 12 hours, acclimatisation: at least 5 days before the experiment startet, Fed: Ratten und Mäusediet Altromin 1324 (Altromin GmbH, Lage/Lippe), ad libitum, Housing: Makrolon cages (type 3) Fully air conditioned rooms, Room temperature: 22+/-2 °C, Source: Hoe: NMRKf (SPF- Zucht), Age of the animals: 7-9 weeks
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- Sesame oil
- Details on exposure:
- The dilution of the test substance was prepared daily.
- Duration of treatment / exposure:
- Application once, after 24h, 48h and 72h the animals were sacrified (different time points-> different groups)
- Frequency of treatment:
- Once administered
Doses / concentrations
- Remarks:
- Doses / Concentrations:
3 doses and 1 positive control
Basis:
- Control animals:
- yes
- Positive control(s):
- Cyclophosphamid-Endoxan
Examinations
- Tissues and cell types examined:
- Bone marrow
- Details of tissue and slide preparation:
- The animals were sacrified in groups 24 h, 48h and 72 hours after application (with CO2). Both Femora were extracted, bones and muscle were removed.
- Statistics:
- The statistical analysis was based the computer programme Diamant.
Results and discussion
- Additional information on results:
- Increased breathing frequence, in the high doses group the animals were calm and dazed, piloerection,
Applicant's summary and conclusion
- Conclusions:
- 3-Methylcrotonic acid is not mutagenic under the above mentioned test conditions .
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