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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Remarks:
The study was conducted in accordance with a recognized international scientific procedure and followed the test protocol and procedures of Ames (1975). Complete study results were presented supporting the conclusions that ethyl methacrylate was not mutagenic in this test system. Full description of the test material was provided.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
1987
Reference Type:
review article or handbook
Title:
The lower alkyl methacrylates: Genotoxic profile of non-carcinogenic compounds
Author:
Albertini, RJ
Year:
2017
Bibliographic source:
Regulatory Toxicology and Pharmacology 84, 77-93

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Qualifier:
according to
Guideline:
other: Ames et al. (1975)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Ethyl Methacrylate; CAS: 97-63-2; purity: > 99 %; supplied by Fluka Chemical Co.

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
The S-9 fractions of Aroclor 1254-induced, male  Sprague-Dawley rats and male Syrian Hamster livers were prepared  immediately prior to use. The S-9 mixes contained 10% S-9. 
Test concentrations with justification for top dose:
100-10000 µg/plate
Controls
Negative solvent / vehicle controls:
yes
Remarks:
ethanol (95%)
Positive controls:
yes
Remarks:
Metabolic activation (S9): 2-Aminoanthracene: with all strains No Metabolic activation:         Sodium azide: TA100 and TA1535         4-Nitro-o-phenylenediamine: TA98         9-Aminoacridine: TA1537
Details on test system and experimental conditions:
TEST PERFORMANCE: The test followed a pre-incubation protocol. The test  material, Salmonella culture, and S-9 mix or buffer were incubated at 37  degrees C, without shaking, for 20 minutes. The top agar was added, and  the contents of the tubes mixed and poured onto the surface of  Vogel-Bonner medium in a petri dish. The histidine-revertant colonies on  these plates were counted after 2 days of incubation at 37 degrees C. 
A  preliminary cytotoxicity assays was conducted using TA100 to determine  the appropriate dose range. Once determined, the test doses were performed  in triplicate, repeated one week following the initial trial. 
A maximum  of 0.5 ml of solvent was added to each plate. Concurrent solvent and  positive controls in the presence or absence of S-9 were performed.
Evaluation criteria:
 A  positive response was demonstrated when a reproducible dose-related  increase over the corresponding solvent control was seen, and it was  judged weakly positive if a low-level dose response was seen.

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
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:
not examined
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
In a reliable published study, the test substance was negative in a bacterial reverse mutation assay.
Executive summary:

In a reliable published study, the test substance was negative in a bacterial reverse mutation assay.