2,6-bis(4-ethylphenyl)perhydro-1,3,5,7-tetraoxanaphth-4-ylethane-1,2-diol

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:

1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2,6-bis(4-ethylphenyl)perhydro-1,3,5,7-tetraoxanaphth-4-ylethane-1,2-diol

EC Number:

406-176-9

EC Name:

2,6-bis(4-ethylphenyl)perhydro-1,3,5,7-tetraoxanaphth-4-ylethane-1,2-diol

Cas Number:

79072-96-1

Molecular formula:

C24 H30 O6

IUPAC Name:

1-[2,6-bis(4-ethylphenyl)-hexahydro-[1,3]dioxino[5,4-d][1,3]dioxin-4-yl]ethane-1,2-diol

Test material form:

solid: particulate/powder

Method

Target gene:

Histidine locus

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:

S. typhimurium TA 1538

Metabolic activation:

with and without

Metabolic activation system:

S9-mix

Test concentrations with justification for top dose:

Concentration range in the main test:
-With metabolic activation: 0.5, 0.15, 0.1, 0.05, 0.015, 0.005 mg/plate
-Without metabolic activation: 0.5, 0.15, 0.1, 0.05, 0.015, 0.005 mg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO
5 mg test materiall / ml DMSO

Results and discussion

Test results

Species / strain:

other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100, TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Additional information on results:

Concentration of the test substance observed to be toxic to bacteria: no toxicity observed.
Concentration of the test substance resulting in precipitation: No precipitation
Other observations: None

Applicant's summary and conclusion

Conclusions:

The test material was considered to be non-mutagenic under the conditions of the test. No indication was observed of the mutagenic potential of the test material with or withour metabolic activation in this bacterial reverse mutation assay.