Reaction products of fatty acids, C12 alkyl and triglycerides, C18 (unsaturated) alkyl with 2-(2-aminoethylamino)ethanol and sodium chloroacetate

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Reverse mutation on bacteria, negative with and without metabolic activation

Link to relevant study records

Reference

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial forward mutation assay

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Additional strain / cell type characteristics:

other: rfa wall mutation to increase permeability to certain classes of chemicals (crystal violet); uvrB mutation, deficient in a DNA excision repair system (UV irradiation sensitivity) TA98 and TA100 contain pKM101 plasmid for resistance to Ampicillin

Species / strain / cell type:

E. coli WP2 uvr A

Additional strain / cell type characteristics:

other: uvrA DNA repair deficiency, sensitivity to UV irradiation

Metabolic activation:

with and without

Metabolic activation system:

S9 tissue fraction from rat liver

Test concentrations with justification for top dose:

Main assay III concentrations (spacing of a factor of 0.5)TA1535 without activiation, 15.6 to 0.977 ug/plateTA1535 with activation 250 to 15.6 ug/plateTA1537 without activation 50 to 1.56 ug/plateTA1537 with activation 2000 to 31.3 ug/plateWP2 uvrA without activation 62 to 3.91 ug/plateWP2 uvrA with activation 2000 to 62.5 ug/plateTA98 without activation 31.3 to 0.977 ug/plateTA98 with activation 2000 to 62.5 ug/plateTA100 without activation 50 to 1.56 ug/plateTA100 with activation 2000 to 62.5 ug/plateThe highest dose was chosen as the maximum level to obtain a sufficient number of analysable concentrations

Positive controls:

yes

Positive control substance:

9-aminoacridine

2-nitrofluorene

sodium azide

methylmethanesulfonate

other: 2-aminoanthracene

Species / strain:

E. coli WP2 uvr A pKM 101

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at the (two) highest dose

Species / strain:

other: TA 1535, TA 1537, TA98 , TA100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at the (two) highets dose level

Conclusions:

The substance was tested following OECD 471 for genetic toxicity to bacteria. Under the experimental conditions the substance did not show amu mutagenic potential in all tested strains.

Executive summary:

The substance was examined for the ability to induce gene mutations in tester strains of Salmonella typhimurium and Escherichia coli, as measured by reversion of auxotrophic strains to prototrophy. The five tester strains TA1535, TA1537, TA98, TA100 and WP2 uvrA were used. Experiments were performed both in the absence and presence of metabolic activation, using liver S9 fraction from rats pre-treated with Phenobarbital and 5,6-Benzoflavone. The test item was used as a solution in sterile water for injection.

Toxocity test was performed as to establish correct doses for the main test, with plate incorporation method. In this first main assay toxicity was observed for all dose levels but TA1535 with activation system.

In the second main assay some dose levels were decresed and pre-incubation step was added since no relevant increase in the number of revertant was observed. However, severe to slight toxicity was again observed and a thrid main assya was performed with lower dose levels.

The substance did not induce reverse mutation of Salmonella T. or Escherichia Coli in the absence or presence of S9 metabolism under the experimental conditions

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Additional information

The substance was tested for in-vitro mutagenicity on bacteria following OECD 471 (Ricci 2016). Under the experimental conditions the substance did not show any mutagenic potential.

Justification for classification or non-classification

Based on the results from in-vitro mutagenicity test the substance is not classified for genetic toxicity under Regulation 1272/2008