Esterification products of glycerol with docosanoic acid, icosanedioic acid and 16-methylheptadecanoic acid

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

One in vitro study on genetic toxicity in bacteria available. Nomcort SG was tested negative for mutagenicity.

Link to relevant study records

Reference

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD Guideline Study under GLP, only one experiment performed, but clearly negative result

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

only one experiment performed

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Target gene:

Histidine, Trypthophan

Species / strain / cell type:

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

Metabolic activation:

with and without

Metabolic activation system:

rat Liver S9 mix

Test concentrations with justification for top dose:

0.05, 0.1, 0.5, 1.0, 5.0 mg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: acetone
- Justification for choice of solvent/vehicle: The test item was found to be completely soluble in the vehicle.

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

2-nitrofluorene

sodium azide

methylmethanesulfonate

other: 2-Aminoanthracene, 6-Chloro-9-[3-(2-chloroethylamino)propylamino]-2-methoxyacridine

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation);

DURATION
- Exposure duration / Expression time): 48 h

NUMBER OF REPLICATIONS: 3

Evaluation criteria:

according to Guideline (OECD 471)

Statistics:

calculation of Average and standard deviation, no further statistics performed

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Additional information on results:

no further remarks

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Conclusions:

Interpretation of results (migrated information):
negative

There was no detectable genotoxic activity or cytotoxicity for Nomcort SG under the conditions of the test.

Executive summary:

The genetic toxicity in bacteria was tested using the method by Ames laid down in OECD Guideline 471. Five strains of bacteria were tested (Salmonella typhimurium 98, 100, 1535, 1537 and Escherichia Coli WP2 uvrA) using a plate incorporation protocol. Nomcort SG was tested in the concentrations 0.05, 0.1, 0.5, 1.0 and 5.0 mg/plate with Acetone as solvent. Additionally positive and solvent control were tested. Metabolic activation was included using rat S9 -liver fraction.

All concentrations, positive and solvent control were tested in triplicate.

Solvent control and positive control were evaluated valid and within the historic data. No concentration of Nomcort SG with or without metabolic activation yielded in an increased mutagenic response, as well as no cytotoxicity was noted.

Nomcort SG was evaluated as NOT MUTAGENIC under the conditions of the test.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

Justification for selection of genetic toxicity endpoint
Only one study available. This study is assessed as reliable and usable.

Justification for classification or non-classification

The presented information is conclusive but not sufficient for classification.