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

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

December 1989 - January 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Well conducted study according to GLP, however, study was carried ou according to the previous version of the guideline. 4 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).

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:

Four 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

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

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

Method

Species / strain

Species / strain / cell type:

bacteria, other: Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537.

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, 500 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

Test results 1

Species / strain:

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

Metabolic activation:

with

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

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

Metabolic activation:

without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

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

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