(1R)-1-[(4R,4aR,8aS)-2,6-bis(3,4-dimethylphenyl)tetrahydro[1,3]dioxino[5,4-d][1,3]dioxin-4-yl]ethane-1,2-diol

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:

No date

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: All information in this endpoint has been provided by the ECHA using the 12 years rule. This data is not owned by the registrant. The reliability is estimated to be at level 2 at a minimum.

Data source

Reference

Reference Type:

other: Body responsible for the test

Title:

Unnamed

Year:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

413-110-2

EC Name:

-

Cas Number:

135861-56-2

Molecular formula:

C24H30O6

IUPAC Name:

(1R)-1-[(4R,4aR,8aS)-2,6-bis(3,4-dimethylphenyl)tetrahydro[1,3]dioxino[5,4-d][1,3]dioxin-4-yl]ethane-1,2-diol

Details on test material:

This information is not provided in the migrated NONS file provided by ECHA.

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:

Main study with and without metabolic activation: from 100 to 5000 µg/plate.

Vehicle / solvent:

Dimethylsulfoxide (DMSO)

Details on test system and experimental conditions:

Test item precipitation observed at 1000 µg/plate.

Evaluation criteria:

This information is not provided in the migrated NONS file provided by ECHA.

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

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

Remarks:

>5000 µg/plate

Any other information on results incl. tables

In the preliminary test no cytotoxicity was observed up to the highest tested concentration (5000 µg/plate).

No more information is available in the migrated NONS file provided by ECHA.

Applicant's summary and conclusion

Conclusions:

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

The test item was not genotoxic for bacteria (S. typhimurium and E. coli).

Executive summary:

All information in this endpoint has been provided by the ECHA using the 12 year rule, this data is not owned by the registrant.

The test item was evaluated for its genotoxicity to bacteria (S. typhimurium and E. coli) according to the OECD Guideline 471. No cytotoxicity was observed up to the higest tested concentration (5000µg/plate) either in the preliminary test or the main test. The test item did not induce any genotoxic response in the considered test system.