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Toxicological information

Genetic toxicity: in vitro

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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

Referenceopen allclose all

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 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

Constituent 1
Chemical structure
Reference substance name:
Hexyl methacrylate
EC Number:
205-521-9
EC Name:
Hexyl methacrylate
Cas Number:
142-09-6
Molecular formula:
C10H18O2
IUPAC Name:
hexyl methacrylate
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.