2-Butanone, 1,1,1,3,4,4,4-heptafluoro-3-(trifluoromethyl)-

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

Study period:

03 May 2012 to 14 May 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted under GLP conditions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

In 2nd exp in tester strain TA100,only 2 plates of test substance conc 3330 μg/plate in presence of S9-mix were tested.All other dose levels were plated in triplicate & testing of extra plate would have given no additional info: deviation had no influence

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Deviations:

yes

Remarks:

In 2nd exp in tester strain TA100,only 2 plates of test substance conc 3330 μg/plate in presence of S9-mix were tested.All other dose levels were plated in triplicate & testing of extra plate would have given no additional info: deviation had no influence

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

MTDID 20422

IUPAC Name:

MTDID 20422

Constituent 2

Reference substance name:

1,1,1,3,4,4,4-heptafluoro-3-(trifluoromethyl)butan-2-one

EC Number:

690-995-3

Cas Number:

756-12-7

Molecular formula:

C5 F10 O

IUPAC Name:

1,1,1,3,4,4,4-heptafluoro-3-(trifluoromethyl)butan-2-one

Test material form:

other: Liquid

Details on test material:

- Name of test material (as cited in study report: MTDID 20422
- Substance type: Pure active substance
- Physical state: Liquid
- Analytical purity: 99.99%
- Purity test date: 02/16/2011
- Expiration date of the lot/batch: 02/16/2013
- Storage condition of test material: At room temperature in the dark.

Method

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:

E. coli WP2 uvr A

Metabolic activation:

with and without

Metabolic activation system:

S9-fraction

Test concentrations with justification for top dose:

100, 333, 1000, 3330, and 5000 ug test article per plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: dimethyl sulfoxide (DMSO) (SeccoSolv, Merck, Darmstadt, Germany)

Controls

Untreated negative controls:

yes

Remarks:

Vehicle used as a negative control.

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

other: Without metabolic act TA1535: sodium azide (SA) TA1537: 2-nitrofluorene (NF) TA98: 2-nitrofluoroene (NF) TA100: methylmethanesulfonate (MMS) WP2uvrA: 4-nitroquinoline N-oxide (4-NQO) With metabolic activation All strains: 2-aminoanthracene (2AA)

Details on test system and experimental conditions:

METHOD OF APPLICATION:Test substance was included in the top agar.
DURATION
- Preincubation period:
- Exposure duration: 48 hours +/- 4 hours.
STAIN (for cytogenetic assays):
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth

Evaluation criteria:

The negative control data (number of spontaneous revertants per plate) should be within the
laboratory historical range for each tester strain. Also, the positive control chemicals should produce responses in all tester strains, which are within the laboratory historical range documented for each positive control substance. Furthermore, the mean plate count should be at least three times the concurrent vehicle control group mean.

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:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

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 EU

No increase in revertant colonies was observed in either the presence or absence or S9 mix for any strain. All criteria for a valid study were met as described in the protocol. Under the conditions of the study, the test article was not mutagenic in the Bacterial Reverse Mutation Assay in either the presence or absence of metabolic activation.

Executive summary:

The mutagenic potential of the test article (clear colorless liquid, purity 99.99%) was evaluated in the Bacterial Reverse Mutation Assay with S. typhimurium strains TA98, TA100, TA1535, and TA1537 and E. coli strain WP2 uvrA in the presence and absence of a metabolic activation system (S9-mix rat liver induced by Phenobarbital and B-napthoflavone). The study was performed in compliance with OECD GLP (1997). The study design was based on OECD No. 471 (1997) and EC 440/2008 B.12/14 L142 (2008). The test article was dissolved in dimethyl sulfoxide. A dose range-finding test was performed at concentrations up to 5000ug/plate in the absence and presence of S9 mix in strains TA100 and WP2uvrA. A second assay was performed in all strains at doses of 100, 333, 1000, 3330, and 5000 ug/plate in the presence or absence of S9 mix. Strain specific positive controls and vehicle controls were tested in parallel. All treatments were performed in triplicate. No increase in revertant colonies was observed in either the presence or absence or S9 mix for any strain. All criteria for a valid study were met as described in the protocol. Under the conditions of the study, the test article was not mutagenic in the Bacterial Reverse Mutation Assay in either the presence or absence of metabolic activation.