3,3,4,4,5,5,6,6,7,7,8,8-dodecafluorodeca-1,9-diene

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

3,3,4,4,5,5,6,6,7,7,8,8-dodecafluorodeca-1,9-diene

EC Number:

217-288-0

EC Name:

3,3,4,4,5,5,6,6,7,7,8,8-dodecafluorodeca-1,9-diene

Cas Number:

1800-91-5

Molecular formula:

C10H6F12

IUPAC Name:

3,3,4,4,5,5,6,6,7,7,8,8-dodecafluorodeca-1,9-diene

Test material form:

other: liquid

Details on test material:

- Substance type: Organic
- Physical state: Liquid
- Analytical purity: 99.6 %
- Impurities (identity and concentrations): Not known
- Lot/batch No.: 941001
- Stability under test conditions: Stable
- Storage condition of test material: Room temperature in the closed bottle.

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 Mix

Test concentrations with justification for top dose:

Preliminary test; 5, 15, 50, 150, 1500, 5000 micro gram/plate
Test; 156.3, 312.5, 625, 1250, 2500, 5000 micro gram/plate

Vehicle / solvent:

DMSO: Dimethylsulfoxide

Controls

Controls 1

Untreated negative controls:

yes

Remarks:

DMSO

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

yes

Remarks:

DMSO

Positive controls:

yes

Positive control substance:

9-aminoacridine

N-ethyl-N-nitro-N-nitrosoguanidine

other: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide

Controls 2

Untreated negative controls:

yes

Remarks:

DMSO

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

yes

Remarks:

DMSO

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene

Details on test system and experimental conditions:

Two plates were used for each of seven different concentrations of the sample in the range-finding study and six different concentrations of the sample in the main test. The liver microsome fraction (S9) was prepared from the liver of Slc:Sprague-Dawley rats prepared with phenobarbital and 5,6-benzoflavone.

Evaluation criteria:

The result was considered positive if the number of colonies found was twice the number of colonies of the control, which was exposured to dimethylsulfoxide, the solvent for test sample, and concentration-related increase over the range tested and reproducible increase at range finding trial and main test were observed.

Results and discussion

Test results

Test results 1

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Key result

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 3

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 4

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 5

Key result

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

negative with and without metabolic activation
The number of revertant colonies in six concentrations, 156.3, 312.5, 625, 1250, 2500 and 5000 microgram/plate did not increase more than twice compare with the solvent control in five bacteria strains with and without activation.
The growth inhibition of the bacteria was not observed.

Executive summary:

The number of revertant colonies in six concentrations, 156.3, 312.5, 625, 1250, 2500 and 5000 microgram/plate did not increase more than twice compare with the solvent control in five bacteria strains with and without activation.

The growth inhibition of the bacteria was not observed either.