3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl methacrylate

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:

other: This study was selected as a key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment.

Data source

Materials and methods

Test guidelineopen allclose all

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Method

Species / strainopen allclose all

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254-induced rat liver S9

Test concentrations with justification for top dose:

33.3, 66.7, 100, 333, 667, 1000, 3333, and 5000 μg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: Ethanol
- Justification for choice of solvent/vehicle: Based on the solubility of the test substance and compatibility with the target cells.

Details on test system and experimental conditions:

METHOD OF APPLICATION: In the non-activated assays, 0.5 mL of sham mix and 100 μL of vehicle, test substance dilution, or positive control were added to pre-heated (45–48°C) glass culture tubes containing 2 mL of selective top agar, followed by 100 μL of tester strain. In the S9-activated assays, 100 μL of the vehicle, test substance dilution, or positive control were added to pre-heated (45–48°C) glass culture tubes containing 2 mL of selective top agar, followed by 100 μL of tester strain and 0.5 mL of S9 mix. All mixtures were vortexed and overlaid onto the surface of minimum glucose agar plate.

DURATION
- Preincubation period: none
- Exposure duration: approximately 48-52 hours at 37 ± 2°C
- Expression time (cells in growth medium): approximately 48-52 hours. Plates that were not evaluated immediately following incubation were stored at approximately 4°C.

NUMBER OF REPLICATIONS: toxicity-mutation tests were plated in duplicate; mutagenicity tests plated in triplicate

NUMBER OF CELLS EVALUATED: tester stain culture density was approximately 10e9 cells per mL.

DETERMINATION OF CYTOTOXICITY
A minimum of 3 non-toxic scorable dose levels were required to validate the study. A dose level was considered toxic if it caused:
- A >50% reduction in the mean number of revertants per plate relative to the mean negative control value and exhibited a dose-dependent drop in the revertant count, or
- A reduction in the background lawn.

Evaluation criteria:

For the test substance to be evaluated positive, it must cause a dose-related increase in the mean revertants per plate unless observed at the top dose level only. Data sets for tester strains TA1535 and TA1537 were judged positive if the increase in mean revertants at the highest numerical dose response was ≥ 3.0-fold the mean concurrent negative control value (vehicle control). Data sets for tester strains TA98, TA100 and WP2 uvrA were judged positive if the increase in mean revertants at the highest numerical dose response was ≥ 2.0-fold the mean concurrent negative control value (vehicle control).

Statistics:

For each selected tester strain, the mean number of revertants and the standard deviation at each concentration with and without S9 activation were calculated.

Results and discussion

Test resultsopen allclose all

Additional information on results:

RANGE-FINDING/SCREENING STUDIES:
No positive mutagenic responses were observed at any dose level in any tester strain in the absence or presence of S9 metabolic activation. No toxicity was observed at any dose level with any tester strain in either the absence or presence of S9. Test substance precipitation was observed starting at 667 μg/plate in both the activated and non-activated test system.

MUTAGENICITY TEST:
No toxicity was observed at any dose level with any tester strain in either the absence or presence of S9. Test substance precipitation was observed starting at 667 μg/plate for TA98, TA100, TA1535, and TA1537 in presence of S9 activation and for WP2uvrA and TA98 in the absence of S9 activation. Test substance precipitation was observed starting at 1000 μg/plate for TA100 in the absence of S9 activation and for WP2uvrA in the presence of S9 activation. For TA1535 and TA1537 in the absence of S9 activation test substance precipitation was observed starting at 3333 μg/plate.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative in the absence and presence of S9 activation

The study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).
Negative when tested in Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 and in Escherichia coli WP2 uvr A in the absence and presence of S9 activation.

Executive summary:

The test substance was evaluated for mutagenicity in Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 and in Escherichia coli WP2uvrA with and without an exogenous metabolic activation system (Aroclor-induced rat liver S9). The maximum concentration tested was 5000 µg/plate. No evidence of mutagenic activity was detected in either the absence or presence of Aroclor-induced rat liver S9. In this study, the test substance was negative.