Fatty acids, C18 (saturated and unsaturated) ethyl esters

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 from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Literature reference. No information on GLP. Level of information and not enough information to assess the study following an official and validated method, but the study is well conducted and scientifically valid

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)

Deviations:

not specified

Principles of method if other than guideline:

NA

GLP compliance:

not specified

Type of assay:

chromosome aberration assay

Test material

Test material information

Constituent 1

Reference substance name:

Analytical grade, obtained from Serva (heidelberg)

IUPAC Name:

Analytical grade, obtained from Serva (heidelberg)

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

Duration of treatment / exposure:

Single treatment

Frequency of treatment:

Single

Post exposure period:

24 h
30 h
48 h

Doses / concentrations

Doses / concentrations 1

Remarks:

Doses / Concentrations:
1
Basis:
nominal conc.

Doses / concentrations 2

Remarks:

Doses / Concentrations:
10
Basis:
nominal conc.

Doses / concentrations 3

Remarks:

Doses / Concentrations:
100
Basis:
nominal conc.

Doses / concentrations 4

Remarks:

Doses / Concentrations:
500
Basis:
nominal conc.

Doses / concentrations 5

Remarks:

Doses / Concentrations:
5000
Basis:
nominal conc.

No. of animals per sex per dose:

6 animals per sex per dose

Control animals:

yes

Positive control(s):

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 (i.e. the read-across substance - see attached waiving and justification document in section 13) doesn't show chromosomal aberration on Chinese Hamster bone-marrow cells until a concentration of 5000 mg/Kg. This conclusion also apply for Fatty acids, C18 (saturated and unsaturated) ethyl esters.

Executive summary:

The clastogenic activity of methyl esters of fatty acids (short-chain to long-chain) were examined in Chinese hamster bone marrow cells using the chromosome aberration test (OECD 475). Experimental animals were treated with fatty acid esters and the mutagen (busulfan), to evaluate the anticlastogenic activity of the methyl esters of fatty acids on chromosome-breaking actions of busulfan. 

In conclusion, methyl ester of fatty acids in chain length from C6 to C20 (i.e. the read-across substance - see attached waiving and justification document in section 13) doesn't show chromosomal aberration (clastogenic activity) on Chinese Hamster bone-marrow cells up to 5000 mg/kg. This conclusion also apply for Fatty acids, C18 (saturated and unsaturated) ethyl esters.