hydrogenated decyl olive oil esters

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

hydrogenated decyl olive oil esters

Molecular formula:

not applicable

IUPAC Name:

hydrogenated decyl olive oil esters

Test material form:

solid

Method

Target gene:

his D, his , his G and tryp E

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

S-9 mix

Test concentrations with justification for top dose:

5 000 µg (recommended maximum test concentration)- 1 500 µg - 500 µg - 150 µg - 50 µg

Vehicle / solvent:

paraffin oil

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

7,12-dimethylbenzanthracene

9-aminoacridine

2-nitrofluorene

sodium azide

other: B-Propiolactone, 2-Anthramine, cis-platinium

Details on test system and experimental conditions:

For each of the strains, 100 µL of the bacterial suspension (1-5 x 109 bacteria/mL) and 100 µL of the test substance are mixed with 2.0 mL of overlay agar and poured over the surface of a minimal agar
plate (90 mm in diameter) (n = 3). The overlay agar is allowed to solidify before incubation.
Plates are incubated at 37° C over a 48 hour period. The number of revertant colonies per plate is counted.

Results and discussion

Test results

Test results 1

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks:

b-propiolactone for test without metabolic activation. 2-anthramine for test with metabolic activation

Test results 2

Key result

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks:

9-aminoacridine for test without metabolic activation. 2-anthramine for test with metabolic

Test results 3

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks:

2-nitrofluorène for test without metabolic activation. 2-anthramine for test with metabolic

Test results 4

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks:

Sodium azide for test without metabolic activation. 2-anthramine for test with metabolic

Test results 5

Key result

Species / strain:

E. coli WP2 uvr A pKM 101

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks:

Cis-platinum for test without metabolic activation. Dimethyl Benzanthracene for test with metabolic

Applicant's summary and conclusion

Conclusions:

There is no evidence of any increase in the number of revertant colonies in the presence of the test substance (5 000 µg - 1 500 µg - 500 µg - 150 µg - 50 µg) without and with metabolic activation.

Executive summary:

The genetox toxicity in vitro was performed according to the OECD 471 guideline.

The test substance does not induce any mutagenic change in Salmonella typhimarium TA1535, TA1537, TA98, TA100 and Escherichia coli WP2, with or without metabolic activation.