N-(1,1-dimethyl-3-oxobutyl)acrylamide

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Three Ames tests, one in vitro chromosome aberration test, and an in vitro/in vivo UDS test were reported. Each with a negative result.

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

Study period:

2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study with GLP.

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Target gene:

histidine

Species / strain / cell type:

S. typhimurium, other: TA97a, TA98, TA100, TA102 and TA1535

Metabolic activation:

with and without

Metabolic activation system:

S9-mix from Aroclor 1254 induced microsomes of rat liver

Test concentrations with justification for top dose:

62, 185, 556, 1667 and 5000 µg per plate without external metabolisation, and62, 185, 556, 1667 and 5000 µg per plate with an external metabolising system

Vehicle / solvent:

Water

Negative solvent / vehicle controls:

yes

Remarks:

Deionised water was used as solvent for the test substance and for the negative control group.

Positive controls:

yes

Positive control substance:

other: see below

Details on test system and experimental conditions:

Positive control substances:- 2-Aminoanthracene- 7,12-Dimethylbenz[a]anthracene- 1,8-Dihydroxy-anthraquinone- 2-Nitrofluorene- Sodium azide- 4-Nitro-o-phenylenediamine- t-Butyl-hydroperoxide1,8-Dihydroxy-anthraquinone, 7,12-dimethylbenz[a]anthracene and 2-aminoanthracene are mutagenic only when activated by a metabolising system; 4-nitro-o-phenylenediamine, 2 nitrofluorene, t butyl-hydroperoxide and sodium azide are directly acting mutagens.

Evaluation criteria:

The criteria for a positive result are: A reproducible increase of the number of revertants to more than the following threshold values for at least one of the concentrations:• For the strains with a low spontaneous revertant rate i.e. TA98 and TA1535: The 2½ fold of the amount of the spontaneous revertants. • For the strains with a high spontaneous revertant rate i.e. TA97a, TA100 and TA102: The 1 2/3 fold of the amount of the spontaneous revertants. These threshold values were derived from the variations in the control samples of historic data of the Ames test.

Statistics:

Means and standard deviations were calculated for the number of mutants in every concentration group.

Species / strain:

S. typhimurium, other: TA97a, TA98, TA100, TA102 and TA1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

All positive control substances increased the mutation frequency to more than the threshold values stated above. As 2-aminoanthracene, 1,8-dihydroxy anthraquinone and 7,12-dimethyl-benz[a]anthracene require metabolic activation for mutagenicity, the results of these substances demonstrate also the efficiency of the metabolising system. The mean results are presented in the attachment.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

No precipitation of the test substance was seen in any of the concentration groups.

In the preliminary test and in the main test no toxicity was seen up to 5000 µg/plate.

There was no increase in the number of mutants in any of the tested bacterial strains at any of the tested concentrations. The addition of an external metabolising system did not change these results.

Conclusions:

Interpretation of results (migrated information):negativeDiacetone acrylamide is not genotoxic in the reverse bacterial mutation assay, in each of the 5 strain tested and with and without an external metabolizing system.

Executive summary:

Diacetone acrylamide was tested for mutagenic activity with the "Salmonella typhimurium Reverse Mutation Test" (Ames Test). The study was conducted in accordance with the OECD-guideline 471 and directive 2000/32/EC, part B.13/14. Diacetone acrylamide is not genotoxic in the reverse bacterial mutation assay, in each of the 5 strain tested, and with and without an external metabolizing system.

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
The most recent guideline study under GLP.

Justification for classification or non-classification

No indications for genotoxic properties and for a classification of the substance were obtained.