1,3-bis(3-methyl-2,5-dioxo-1H-pyrrolinylmethyl)benzene

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

December 1989 - January 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well conducted study according to GLP, however, study was carried out according to the previous version of the guideline. Only 4 Salmonella strains were used.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

see below

Principles of method if other than guideline:

Only four Salmonella strains were used, but not one of the strains having AT base pairs at the primary reversion site (such as TA 102 or E. coli WP2 strains).

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

1,3-bis(3-methyl-2,5-dioxo-1H-pyrrolinylmethyl)benzene

EC Number:

412-570-1

EC Name:

1,3-bis(3-methyl-2,5-dioxo-1H-pyrrolinylmethyl)benzene

Cas Number:

119462-56-5

Molecular formula:

Hill formula: C18 H16 N2 O4

IUPAC Name:

3-methyl-1-({3-[(3-methyl-2,5-dioxo-2,5-dihydro-1H-pyrrol-1-yl)methyl]phenyl}methyl)-2,5-dihydro-1H-pyrrole-2,5-dione

Details on test material:

Batch no: BOM pp2
Purity: 87 ± 3% (m/m); see CoA attached
Other: m-Xylylene bis (itaconimide): 2-5%
appearance: brown powder

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254 induced rat liver S-9 mix.

Test concentrations with justification for top dose:

Concentrations in the RF test: 5, 50, 500 and 5000 µg/plate
Concentrations in the main test (with and without metabolic activation): 50, 150, 500, 1500, 5000 µg/plate

Vehicle / solvent:

Solvent: Dimethylsulphoxide

Controls

Controls 1

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

other: 9-aminoacridine, N-ethyl-N'-nitro-N-nitrosoguanidine, 2-nitrofluorene

Remarks:

without S-9 mix

Controls 2

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene

Remarks:

with S-9 mix

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Additional information on results:

The test substance was negative in Salmonella typhimurium strains TA 1535, TA 1537, TA 98, and TA 100 with and without metabolic activation.

Applicant's summary and conclusion

Conclusions:

Interpretation of results: negative

When tested up to dose levels of 5000 µg/plate, Perkalink 900 was not mutagenic in this bacterial test system.

Executive summary:

The test substance (solved in DMSO) was tested in an Ames Test performed according to OECD TG 471 in 1990 with the 4 Salmonella typhimurium strains TA 1535, TA 1537, TA 98, and TA 100. Doses of up to and including 5000 µg/plate did not show mutagenic effects in this bacterial system with and without external metabolization.