Hexyl methacrylate

Genetic toxicity: in vitro

Administrative data

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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Similar to OECD-guideline 471. Study well documented, meets generally accepted scientific principles, acceptable for assesment

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Non-mutagenicity of 27 aliphatic acrylate esters in the Salmonella-microsome test.

Author:

Waegemaekers THJM, Bensink MPM

Year:

1984

Bibliographic source:

Mutat. Res. 137: 95-102

Reference 2

Reference Type:

review article or handbook

Title:

Unnamed

Year:

2008

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Principles of method if other than guideline:

Method: standard procedure as described by Ames et al. (1975) Ames test

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

hexyl 2-methylprop-2-enoate

EC Number:

205-521-9

Cas Number:

142-09-6

Molecular formula:

C10H18O2

IUPAC Name:

hexyl 2-methylprop-2-enoate

Test material form:

liquid

Details on test material:

2-Propenoic acid, 2-methyl, hexylester (CAS: 142-09-6)
Supplier: Polyscience Inc.
Purity: 97 %

Method

Target gene:

his-

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA1535, TA1537, TA1538, TA98, TA100

Metabolic activation:

with and without

Metabolic activation system:

AROCLOR 1254 or phenobarbitone induced rat liver S9 mix.

Test concentrations with justification for top dose:

40-25000 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO

Controls

Untreated negative controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

sodium azide

benzo(a)pyrene

other: 2-Aminoantracene

Details on test system and experimental conditions:

Salmonella typhimurium reverse mutation assay, Ames test
To minimise evaporation treated plates were sealed in glass air-tight exposure jars.

Results and discussion

Test results

Key result

Species / strain:

S. typhimurium, other: TA1535, TA1537, TA1538, TA98, TA100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Untreated negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

Using a valid scientific method, n-Hexyl methacrylate was negative for genotoxicity in the Salmonella typhimurium reverse mutation assay.

Executive summary:

The potential of n-hexyl methacrylate (n-HMA) to induce reverse mutation in Salmonella typhimurium (strains: TA 98, TA 100, TA 1535, TA 1537, TA1538) was evaluated on triplicate plates according to a protocol comparable to the OECD guidelines 471 (standard Ames assay, Waegermakers et al., 1984). n-hexyl methacrylate was tested with and without a metabolic activation system, according to the standard procedure as described by Ames et al. (1975). At least 4 concentrations up to 2500 µg/plate were tested. n-HMA was once tested with phenobarbial-induced S9 mix, once with Aroclor-1254 -induced S9 mix and twice without any additional metabolizing system. n-HMA was diluted in DMSO prior to use. Solvent controls, positive controls and sterility controls for S9 mix were run with each experiment. His+ (histidine dependent) colonies arising on plates were manually-counted after 48 to 72 h after incubation in the dark at 37 °C. The positive control chemicals induced a significant increase of the revertant frequency in all tester strains, either with or without metabolic activation. n-HMA was negative, in the presence and absence of metabolic activation, in all tester strains.

Using a valid scientific method, n-Hexyl methacrylate was negative for genotoxicity in the Salmonella typhimurium reverse mutation assay.