Registration Dossier

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:
1986
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:
OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
Deviations:
not specified
GLP compliance:
no
Type of assay:
chromosome aberration assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
Analytical grade, obtained from Serva (heidelberg)

Test animals

Species:
hamster, Chinese
Strain:
not specified
Sex:
male/female
Details on test animals 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