Fatty acids, C10-30, esters with lanolin alcs.

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

In an Ames test the substance was tested in salmonella typhimurium strains TA1535, TA1537, TA98, TA100 and E. colistrain WP2uvrAin presence and absence of metabolic activation. No increase in mutant frequency was reported in any of the strains tested both in presence and absence of metabolic activation. The substance is considered to be non-mutagenic under the conditions of this test.

Link to relevant study records

Reference

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14 July 2017 to 29 September 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)

Qualifier:

according to guideline

Guideline:

JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Target gene:

histidine/tryptophan

Species / strain / cell type:

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

Details on mammalian cell type (if applicable):

CELLS USED
- Source of cells: University of California, Berkeley, on culture discs, on 04 August 1995, British Industrial Biological Research Association, on a nutrient agar plate, on 17 August 1987.
- Methods for maintenance in cell culture if applicable: stored at -196 °C in a Statebourne liquid nitrogen freezer, model SXR 34

Metabolic activation:

with and without

Metabolic activation system:

phenobarbital/beta-naphthaflavone induced rat liver S9 (Lot No. PB/BNF S9 20-08-2017 )

Test concentrations with justification for top dose:

Test 1 (plate incorporation): 1.5, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate
Test 2 (pre-incubation): 15, 50, 150, 500, 1500 and 5000 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: tetrahydrofurane
- Justification for choice of solvent/vehicle: substance is insoluble isterile distilled water, dimethyl sulphoxide, dimethyl formamide and acetonitrile at 50 mg/mL, acetone at 100 mg/mL and tetrahydrofuran at 200 mg/mL
A suspension in THF was considered as best doseable.

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

THF (in both tests <0.05 mL in final test solution)

Positive controls:

yes

Positive control substance:

4-nitroquinoline-N-oxide

9-aminoacridine

N-ethyl-N-nitro-N-nitrosoguanidine

benzo(a)pyrene

other: 2-Aminoanthracene

Details on test system and experimental conditions:

METHOD OF APPLICATION: exp 1 plate incorporation; exp 2 preincubation

DURATION
- Preincubation period: 20 min at 37 ± 3 °C
- Exposure duration: 48 h at 37 ± 3 °C

NUMBER OF REPLICATIONS: 3/concentration

DETERMINATION OF CYTOTOXICITY
- Method: visible reduction in the growth of the bacterial background lawn

Evaluation criteria:

a substance is considered positive when:
1. A dose-related increase in mutant frequency over the dose range tested (De Serres and Shelby, 1979).
2. A reproducible increase at one or more concentrations.
3. Biological relevance against in-house historical control ranges.
4. Statistical analysis of data as determined by UKEMS (Mahon et al., 1989).
5. Fold increase greater than two times the concurrent solvent control for any tester strain (especially if accompanied by an out-of-historical range response (Cariello and Piegorsch, 1996)).

Statistics:

Dunnetts Regression Analysis

Key result

Species / strain:

other: TA1535, TA1537, TA98, TA100 and WP2uvrA

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Remarks:

precipitate at 1500 ug/plate and above; in exp 2 reduced bacterial backgrownd lawn at 1500 ug/plate in TA 100 and TA1535 and at 5000 ug/plate in TA 100, TA1535 and TA98

Vehicle controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: the precipitate did not hinder scoring of the number of revertants

Conclusions:

Based on the findings in this test the substance is considered non-mutagenic in bacteria

Executive summary:

In an Ames test the substance was tested in salmonella typhimurium strains TA1535, TA1537, TA98, TA100 and E. coli strain WP2uvrA in presence and absence of metabolic activation. No increase in mutant frequency was reported in any of the strains tested both in presence and absence of metabolic activation. The substance is considered to be non-mutagenic under the conditions of this test.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Justification for classification or non-classification

Based on the information available, the substance does not need to be classified for mutagenicity according to Regulation (EC) No 1272/2008 (CLP).