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

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)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

944-415-3 solution

IUPAC Name:

944-415-3 solution

Details on test material:

UVCB substancePhysical form: liquidsolubility/dispersability > 300 g/ltest item storage: room temperature, protected from lightStability: stable under storage conditionsExpiry date: 31 December 2018

Method

Species / strain

Species / strain 1

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 2

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

Controls

Positive controls:

yes

Positive control substance:

9-aminoacridine

2-nitrofluorene

sodium azide

methylmethanesulfonate

other: 2-aminoanthracene

Results and discussion

Test results

Test results 1

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

Test results 2

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

Applicant's summary and conclusion

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