(S,S)-1,1,1,2,2,3,4,5,5,5-decafluoropentane;reaction mass of: (R,R)-1,1,1,2,2,3,4,5,5,5-decafluoropentane

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:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

Remarks:

Conducted according to guideline in effect at time of study conduct.

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Health Effects Testing Guidelines of US EPA (40 CRF 798.5265)

Deviations:

no

Remarks:

The study was conducted according to guideline in effect at the time of study conduct.

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

420-640-8

EC Name:

-

Cas Number:

138495-42-8

Molecular formula:

C5H2F10

IUPAC Name:

(3R,4R)-1,1,1,2,2,3,4,5,5,5-decafluoropentane; (3S,4S)-1,1,1,2,2,3,4,5,5,5-decafluoropentane

Details on test material:

- Purity: 99.68%

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium, other: TA100, TA1535, TA97, TA98

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A pKM 101

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254-induced rat liver S9

Test concentrations with justification for top dose:

0, 10, 50, 100, 500, 1000, 2500, 5000 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Based on information supplied by the sponsor.

Controls

Untreated negative controls:

yes

Remarks:

DMSO

Negative solvent / vehicle controls:

yes

Remarks:

DMSO, water

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene(all strains +S9), 2-nitrofluorene (TA98 -S9), sodium azide (TA100 and TA1535 -S9), ICR-191 acridine (TA97 -S9), methyl methane sulfonate (WP2urvA -S9)

Details on test system and experimental conditions:

METHOD OF APPLICATION: The plate incorporation method was applied. Treatment without activation was conducted by adding 0.1 mL of overnight culture containing 1E8 bacteria to top agar supplemented with L-histidine, biotin (for Salmonella strains) or L-tryptophan (for E. coli). The components were mixed and poured onto a plate containing Davis minimal agar. Treatments with activation were conducted as those without activation except that S9 mix was added to the bacteria/top agar mixture before it was poured onto a Davis minimal agar plate. The plates were incubated at approximately 37°C for approximately 48 hours.

DURATION
- Exposure duration: 48 hours

NUMBER OF REPLICATIONS: 2 trials with 3 treatments per concentration

Evaluation criteria:

A test substance was classified as positive when (1) the average number of revertants in any strain at any test substance concentration studied is at least 2 times greater than the average number of revertants in the negative control AND (2) there is a positive dose-response relationship in that same strain. A test substance is classified as negative when (1) there are no test substance concentrations with an average number of revertants which is at least 2 times greater than the average number of revertants in the solvent control OR (2) there is no positive dose-response relationship. A test substance is classified as equivocal when the test substance is not clearly negative yet does not meet the criteria for a positive response.

Statistics:

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

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium, other: TA100, TA1535, TA97, TA98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

E. coli WP2 uvr A pKM 101

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

ADDITIONAL INFORMATION ON CYTOTOXICITY: Background lawn was noticeably thinner and/or size of microcolonies slightly larger than controls in TA1535 at 2500 µg/plate (without activation) and TA98 at 5000 µg/plate (without activation). Background lawn was markedly thinner and/or microcolonies were markedly larger than controls in TA1535 at 5000 µg/plate(without activation).

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

The study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability). The test substance was negative when tested in Salmonella typhimurium strains TA100, TA1535, TA97, and TA98 and in Escherichia coli WP2uvrA (pKM101) in the absence and presence of S9 activation.

Executive summary:

The test substance was evaluated for mutagenicity in Salmonella typhimurium strains TA100, TA1535, TA97, and TA98 and in Escherichia coli WP2uvrA (pKM101) with and without an exogenous metabolic activation system (S9). The maximum concentration tested was 5000 µg/plate. No evidence of mutagenic activity was detected in either of two independent trials. In this study, the test substance was negative.