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Toxicological information

Genetic toxicity: in vitro

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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:
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

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%
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
Controlsopen allclose all
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
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.