Registration Dossier

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

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:
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:
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: Dimethylsulphoxide
Controlsopen allclose all
Solvent controls:
yes
Positive controls:
yes
Positive control substance:
other: 9-aminoacridine, N-ethyl-N'-nitro-N-nitrosoguanidine, 2-nitrofluorene
Remarks:
without S-9 mix
Solvent controls:
yes
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene
Remarks:
with S-9 mix

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity:
yes
Vehicle controls valid:
yes
Positive controls valid:
yes
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity:
yes
Vehicle controls valid:
yes
Positive controls valid:
yes
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.