Octyl 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:

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

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

Test material information

Constituent 1

Reference substance name:

Octyl methacrylate

EC Number:

218-465-5

EC Name:

Octyl methacrylate

Cas Number:

2157-01-9

Molecular formula:

C12H22O2

IUPAC Name:

octyl 2-methylprop-2-enoate

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 / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Species / strain 2

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 results

Test results 1

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

Test results 2

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.