Fyroflex SOL-DP

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:

other: Very similar to the appropriate guidelines

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

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:

Salmonella-Escherichia coli / Mammalian-Microsome reverse
mutation screening study. Ames, BN, McCann, J. Yamasaki, E.
"Methods for detecting carcinogens and mutagens with the
Slamonella/Mammalian microsome mutagenicity test", Mutation
Research, Vol. 31:347-364(1975).

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

E-AF098T (Batch No. T# 176-3), a white powder. Stored at room temp, dry, closed container.

Method

Target gene:

Histidine and Tryptophan

Species / strain

Species / strain / cell type:

bacteria, other: Salmonella typhimurium TA1535, TA1537, TA98, TA100 and E. coli WP2 uvrA

Details on mammalian cell type (if applicable):

not relevant

Additional strain / cell type characteristics:

other: Strains TA98 and TA1537 were capable of detecting frameshift mutagens, strains TA100 and TA1535 are capable of detecting base-pair substitution mutagens

Metabolic activation:

with and without

Metabolic activation system:

S9 homogenate, liver microsomal enzymes, commercially purchased produced from Spague-Dawley rats that have been injected with Arocolor 1254 (200 mg/ml in corn oil)

Test concentrations with justification for top dose:

Concentration range in the test (without metabolic activation): 1, 3.33, 10, 33.3, 100, 333, 1000, 3330, 5000 µg/plate
Concentration range in the test (without metabolic activation): 10, 33.3, 100, 333, 1000, 3330, 5000 µg/plate

Vehicle / solvent:

Solvent: DMSO

Details on test system and experimental conditions:

See attached document of test system

Evaluation criteria:

Criteria for a positive response: 1) For tester strains TA98, TA100 and WP2urA: For a test article to be considered positive, it must produce at least a 2-fold
increase in the mean revertants per plate of at least one of these tester strains over the mean revertants per plate of the appropriate vehicle control.
2) For tester strains TA1535 and TA1537: For a test article to be considered positive, it must produce at least a 3-fold increase in the mean revertants per
plate of at least one of these tester strains over the mean revertants per plate of the appropriate vehicle control.

Statistics:

See above "Evaluation criteria".

Results and discussion

Test results

Species / strain:

other: as specified above

Metabolic activation:

with and without

Genotoxicity:

negative

Remarks:

(> 5000 µg/plate)

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Remarks:

(> 5000 µg/plate)

Vehicle controls validity:

valid

Positive controls validity:

valid

Additional information on results:

Observations:
No positive increase in mean number of revertants per plate
observed with any of the tester strains in the presence or
absence of S9 mix. A 3.75 increase in the mean number of
revertants per plate was observed with tester strain TA 1537
in the absence of S9 mix, but not meeting the criteria for
a postive eveluation.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

See attached Tables (Summary of Results-tables 1 & 2)

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative without metabolic activation

The results indicate E-AF098T was negative in the Salmonella - E. coli/Mammalian- Microsom Reverse Mutation Screening Study under the conditions, and according to the criteria, of the study.

Executive summary:

The results indicate E-AF098T was negative in the Salmonella - E. coli/Mammalian- Microsom Reverse Mutation Screening Study under the conditions, and according to the criteria, of the study.