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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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Principles of method if other than guideline:
Method: Ames test
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
2-Propenoic acid, 2-methyl, octylester (CAS: 2157-01-9)
Supplier: -
Purity: no data, commercial grade assumed

Method

Target gene:
his-
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
S. typhimurium TA 97
Metabolic activation:
with and without
Metabolic activation system:
S9 mix from Aroclor 1254 induced Sprague Dawley rat liver and male Syrian Hamster liver (10 or 30 %).
Test concentrations with justification for top dose:
At least five doses tested in triplicate.
S. typhimurium TA 100: 100 - 10000 µg/plate
S. typhimurium TA 1535: 100 - 10000 µg/plate
S. typhimurium TA 1537: 100 - 1000 µg/plate
S. typhimurium TA 98: 33 - 10000 µg/plate
S. typhimurium TA 97: 1 - 10000 µg/plate
Vehicle / solvent:
95 % ethanol
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: without S9: sodium azide, 9-aminoacridine and 4-nitro-o-phenylenediamine. With S9: 2-aminoanthracene
Details on test system and experimental conditions:
Salmonella typhimurium reverse mutation assay
Two preincubation assays were conducted.
Evaluation criteria:
An individual trial was judged (+) mutagenic if a dose related increase over the corresponding solvent control was seen, and it was judged weakly mutagenic (+W) if a low dose response was seen. A trial was considered questionable (?) if a dose related increase was judged insufficiently high to justify a call of "+W" if only a single dose was elevated over control or if a non-dose related increase was seen. A chemical was judged weakly mutagenic "+W' or mutagenic "+" if it produced a reproducible, dose related increase in his+ revertants over the corresponding solvent controls in replicate trials.

Results and discussion

Test resultsopen allclose all
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:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 97
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
S9 mix from Aroclor 1254 induced Sprague Dawley rat liver and male Syrian Hamster liver (10% or 30 % in test concentration)
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results: negative

Using a valid scientific method, n-Octyl methacrylate was negative in the presence or absence of metabolic activation for genotoxicity in the Salmonella typhimurium reverse mutation assay.
Executive summary:

A Salmonella typhimurium reverse mutation assay was performed with n-Octyl methacrylate similar to OECD Guideline 471 (GLP compiance not specified). Salmonella typhimurium strains, TA 97, TA98, TA100, TA1535 and TA1537 were exposed to eight concentrations (0 - 10000 µg/plate) of n-Octyl methacrylate in the presence and absence of a metabolic activation system using the plate incorporation and the preincubation methods. All doses of n-Octyl methacrylate, vehicle control and positive controls were plated in duplicate and incubated for 48-72 hours at 37 ºC. The positive controls gave expected responses. Treatment of the S. typhimuriums trains with n-Octyl methacrylate in the presence or absence of metabolic activation did not induce any significant increases in the revertant numbers.

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