[No public or meaningful name is available]

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2021

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2021

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 reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Docosan-1-ol, icosan-1-ol, octadecan-1-ol and their reaction products with betaine and ethanesulphonic acid

IUPAC Name:

Docosan-1-ol, icosan-1-ol, octadecan-1-ol and their reaction products with betaine and ethanesulphonic acid

Test material form:

solid: bulk

Method

Target gene:

hisC3076
hisD3052
hisG46
hisG428
uvrB
rfa
pKM101
pAQ1

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

S9-mix is a liver enzyme mixture used for the test with metabolic activation. It consists of S9 (liver enzyme mixture), buffer, salts, NADP and Glucose-6-phosphate.

Vehicle / solvent:

In a non-GLP pre-test, the solubility of the test item was determined in demineralized (de-min.) water, dimethyl sulfoxide (DMSO), acetone and ethanol.
The test item is not soluble in a concentration of 50 mL/L in any of the tested solvents, but it is possible to test a suspension.

Based on these results of the non-GLP pre-test, ethanol was used as solvent in the experiments, as the test item shows the most consistent suspension in ethanol.

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

benzo(a)pyrene

other: 4-Nitro-1,2-phenylene diamine for strains TA98, TA102 and TA1537, without metabolic activation; 2-amino-anthracene for strains TA100, TA102, TA1535 and TA1537,with metabolic activation

Results and discussion

Test results

Species / strain:

other: Strains: S. TyphimuriumTA98, TA100, TA102, TA1535, TA1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity, but tested up to precipitating concentrations

Vehicle controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Executive summary:

The test item Commercial name: CosmeGreen ES1822+ Substance name: Reaction mass between glycine betaine, ethanesulphonic acid, octadecan-1-ol, docosan-1-ol and eicosan-1-ol was tested in the Bacterial reverse mutation assay with five strains of Salmonella typhimurium (TA98, TA100, TA102, TA1535 and TA1537).

The study was performed with the plate incorporation (experiments 1 and 1b) and pre-incubation method (experiment 2) in the absence and presence of a metabolic activation system (S9).

The test item (dissolved in Ethanol) was tested up to concentrations of 5000 µg/plate in all three experiments.

The test item showed precipitates on the plates at the highest test item concentrations, but the precipitates did not interfere with the scoring of the colonies.

The bacterial background lawn was not affected at any of the tested concentrations and the reduction at 5000 and 1500 µg/plate in experiment 1 for TA98 could not be verified in experiment 1b. Thus, the test item showed no relevant signs of toxicity.

The results of all three experiments showed that in none of the tested concentrations a relevant or dose-related increase in the number of revertants in all tested strains, in the presence and the absence of metabolic activation could be found.

Based on the results of this study it is concluded that Commercial name: CosmeGreen ES1822+ Substance name: Reaction mass between glycine betaine, ethanesulphonic acid, octadecan-1-ol, docosan-1-ol and eicosan-1-ol is not mutagenic in the Salmonella typhimurium test strains TA98, TA100, TA102, TA1535 and TA1537 in the absence and presence of metabolic activation under the experimental conditions of the present study.