4,5-Dihydro-5-methyl-3,4-diphenyl-5-isoxazolol

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:

4 Nov. 1997 - 26 Nov. 1997

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Performed in a test laboratory, not performed in accordance with approved test guideline or GLP standards.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)

Deviations:

not specified

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

443-400-4

EC Name:

-

Cas Number:

181696-73-1

Molecular formula:

C16H15NO2

IUPAC Name:

4,5-Dihydro-5-methyl-3,4-diphenyl-5-isoxazolol

Test material form:

other: Solid

Details on test material:

- Name of test material (as cited in study report): SC-66285

Method

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA 97a, TA 98, TA 100, TA 102 and TA 1535

Metabolic activation:

with and without

Metabolic activation system:

Rat liver S9 fraction

Test concentrations with justification for top dose:

The concentrations of SC-66285 tested in the mutagenicity assay were 10, 50, 100, 500, 1000, and 5000 μg/plate.

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: Dimethyl sulfoxide (DMSO)

Controls

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

Positive controls:

yes

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 2 days

NUMBER OF REPLICATIONS: 3

Evaluation criteria:

POSITIVE:
The test article induces an increase of revertants with increasing dosage. The increases
should be at least two times (TA97a, TA98, TA100, TA102) or three times (TA1535)
greater than the vehicle control at two or more successive dosages or the response should
be repeatable at a single dose.

NEGATIVE:
The test article does not induce a response which fulfills the above criteria.

Results and discussion

Test results

Species / strain:

other: TA 97a, TA 98, TA 100, TA 102 and TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

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

SC-66285 is not mutagenic under the conditions of this test system.

Executive summary:

SC-66285 is not mutagenic under the conditions of this test system.