Registration Dossier
Registration Dossier
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EC number: 700-100-0 | CAS number: 39716-58-0
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)
- Rationale for reliability incl. deficiencies:
- other: study well documented, meets generally accepted scientific principles, acceptable for assessment
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Study of arificial flavouring substances for mutagenicity in the Salmonella/microsome, Basc and micronucleus tests
- Author:
- D. Wild, M.-T. King, E. Gocke and K. Eckhardt
- Year:
- 1 983
- Bibliographic source:
- Food and Chemical Toxicology, 21(6):707-719
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- not specified
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Pent-4-enoic acid
- EC Number:
- 209-732-7
- EC Name:
- Pent-4-enoic acid
- Cas Number:
- 591-80-0
- Molecular formula:
- C5H8O2
- IUPAC Name:
- pent-4-enoic acid
- Details on test material:
- - Name of test material (as cited in study report): Allylacetic acid (Pentenoic acid)
- Physical state: no data
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Purity test date: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ivanovas GmbH
- Age at study initiation: 10 - 14 weeks
- Weight at study initiation: no data
- Fasting period before study: no data
- Housing: no data
- Diet: standard chow ad libitum
- Water: ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod: no data
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- - Vehicle(s)/solvent(s) used: olive oil
- Justification for choice of solvent/vehicle: no data
- Concentration of test material in vehicle: no data - Duration of treatment / exposure:
- 30 hours
- Frequency of treatment:
- 2
- Post exposure period:
- no
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100, 175, 250 mg/kg bw
Basis:
no data
- No. of animals per sex per dose:
- 4 animals per dose
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- no data
Examinations
- Tissues and cell types examined:
- Polychromatic erythrocytes of the bone marrow
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
no data
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields):
mice were treated twice at 0 and 24 hours
mice were killed for preparation at 30 hours
DETAILS OF SLIDE PREPARATION:
no data
METHOD OF ANALYSIS:
no data - Evaluation criteria:
- no data
- Statistics:
- statistical significance was determined according to the methods of Kastenbaum and Bowman
Results and discussion
Test results
- Sex:
- not specified
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- RESULTS OF DEFINITIVE STUDY
- Induction of micronuclei:
dose 0 mg/kg bw: 2.0 micronucleated polychromatic erytrocytes/ 1000 polychromatic erytrocytes
dose 100 mg/kg bw: 1.3 micronucleated polychromatic erytrocytes/ 1000 polychromatic erytrocytes
dose 175 mg/kg bw: 2.7 micronucleated polychromatic erytrocytes/ 1000 polychromatic erytrocytes
dose 250 mg/kg bw 2.2 micronucleated polychromatic erytrocytes/ 1000 polychromatic erytrocytes
- Ratio of PCE/NCE: no data
- Appropriateness of dose levels and route: no data
- Statistical evaluation: no data
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Under the test conditions of the study 4-Pentenoic acid showed no mutagenic properties in the mouse bone marrow micronucleus assay.
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