Registration Dossier
Registration Dossier
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EC number: 285-200-8 | CAS number: 85049-31-6
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study is from literature, no information about GLP and not enough information to assess the study following an official and validated method, but the study is well conducted and scientifically valid
Data source
Reference
- Reference Type:
- publication
- Title:
- The anticlastogenic potential of fatty acid methyl esters
- Author:
- Renner H.W.
- Year:
- 1 986
- Bibliographic source:
- Mutation Research/Genetic Toxicology Volume 172, Issue 3, December 1986, Pages 265-269
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- Deviations:
- not specified
- GLP compliance:
- no
- Type of assay:
- chromosome aberration assay
Test material
- Reference substance name:
- Lauric acid methyl ester
- IUPAC Name:
- Lauric acid methyl ester
- Reference substance name:
- Palmitic acid methyl ester
- IUPAC Name:
- Palmitic acid methyl ester
- Reference substance name:
- Stearic acid methyl ester
- IUPAC Name:
- Stearic acid methyl ester
- Reference substance name:
- Oleic acid methyl ester
- IUPAC Name:
- Oleic acid methyl ester
- Reference substance name:
- Linoleic acid methyl ester
- IUPAC Name:
- Linoleic acid methyl ester
- Reference substance name:
- Linolenic acid methyl ester
- IUPAC Name:
- Linolenic acid methyl ester
- Details on test material:
- Analytical grade, obtained from Serva (heidelberg)
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Test animals
- Species:
- hamster, Chinese
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 6 male + 6 female
12 -18 weeks old
weighing 30-40 g
Animal were in-house bred and had free access to laboratory chow and tap water
Animals were kept in temperature controlled rooms (21+/- 1°C) on a 12h light/dark cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- Liquid paraffin
- Frequency of treatment:
- Singel treatment
- Post exposure period:
- 24 h
30 h
48 h
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
1 mg/Kg
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
10 mg/Kg
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
100 mg/Kg
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
500 mg/Kg
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
5000 mg/Kg
Basis:
nominal conc.
- No. of animals per sex per dose:
- 6 animals per sex per dose
- Control animals:
- yes
- Positive control(s):
- Yes, with busulfan
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Methyl ester of fatty acids in chain lenght from C6 to C20 doesn't show chromosomal aberration on Chinese Hamster bone-marrow cells until a concentration of 5000 mg/Kg - Executive summary:
To test for possible anticlastogenic effects of fatty acids, the methyl esters of fatty acids — short-chain to long-chain — were examined on busulfan in Chinese hamster bone-marrow cells using the chromosome aberration test. When the experimental animals were treated with fatty acid esters and the mutagen, the chromosome-breaking actions of busulfan were not modulated by the short-chain fatty acids, but the fatty acids from lauric acid (C12) up to nonadecanoic acid (C19) reduced the rate of aberrant metaphases from 9.4 to about 3% at doses of 100 mg/kg and less. Other chemical properties of the fatty acids (saturated or not, number of double bonds, even- or odd-numbered) had no influence on the anticlastogenic effects. The only exceptions to this rule were arachidonic acid, which had no effect, and γ-linolenic acid, which had no consistent effect on the action of busulfan
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