Pyrrolo[3,4-c]pyrrole-1,4-dione, 3,6-bis([1,1'-biphenyl]-4-yl)-2,5-dihydro-

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro cytogenicity / chromosome aberration study in mammalian cells

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study was performed following GLP standards and EEC, B.10 guidelines. However, full study report is not available as the data is > 12 year old and summaries have been prepared using data provided by ECHA.

Data source

Reference

Reference Type:

other: Body responsible for the test

Title:

Unnamed

Year:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)

GLP compliance:

yes

Type of assay:

other: non-bacteriological in vitro 6th amendment data

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

413-920-6

EC Name:

-

Cas Number:

88949-33-1

Molecular formula:

C30H20N2O2

IUPAC Name:

3,6-bis({[1,1'-biphenyl]-4-yl})-1H,2H,4H,5H-pyrrolo[3,4-c]pyrrole-1,4-dione

Constituent 2

Reference substance name:

3,6- bis-biphenyl-4-yl-2,5-dihydropyrrolo[3,4-c]pyrrole-1,4-dione

IUPAC Name:

3,6- bis-biphenyl-4-yl-2,5-dihydropyrrolo[3,4-c]pyrrole-1,4-dione

Method

Species / strain

Species / strain / cell type:

Chinese hamster lung fibroblasts (V79)

Metabolic activation:

with and without

Metabolic activation system:

Aroclor-induced rat liver S9-mix.

Test concentrations with justification for top dose:

Concentration range in the main test (with metabolic activation): 1 to 6 µg/mL
Concentration range in the main test (without metabolic activation): 1 to 6 µg/mL

Vehicle / solvent:

DMSO

Details on test system and experimental conditions:

Exposure period (with metabolic activation): 4 hours
Exposure period (without metabolic activation): 4 hours

Fixation time:
6th Amendment fixation time : 18

Results and discussion

Test results

Species / strain:

Chinese hamster lung fibroblasts (V79)

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Additional information on results:

Observations: Due to the poor solubility of the test substance the study was conducted as a suspension. There was no reproducible reduction of the miotic indices.
A second test was conducted with an fixation time of 28 h but showed the same results

Applicant's summary and conclusion

Conclusions:

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

In a study carried out in accordance with GLP and EEC guideline B.10, test substance (EC No. 413-920-6) was evaluated for its genotoxicity potential by in vitro mammalian chromosome aberration test with and without aroclor induced metabolic activation at test concentration of 1 to 6 µg/mL in Chinese hamster lung fibroblast (V79) cell lines. No genotoxicity was observed at tested concentration.

Test substance was not found to be genotoxic with and without metabolic activation under test conditions.