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Diss Factsheets

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:
2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study by a laboratory having a GLP certificate

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
certificate on october 1st 2008
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Target gene:
The objective of the study was to evaluate the potential of the test item Urethane Resin M2001 (batch N°. 081128K) to induce reverse mutation in Salmonella typhimurium.
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
DNA polymerase A deficient
Metabolic activation:
with and without
Metabolic activation system:
S9 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
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

The number of revertants for the vehicle and positive controls was as specified in the acceptance criteria. The study was therefore considered valid.

Since the test item was freely soluble and non-toxic, the highest selected dose-level was 5000 µg/plate, according to the criteria specified in the international guidelines.

Experiments without S9 mix

The selected treatment-levels were 312.5, 625, 1250, 2500 and 5000 µg/plate for both mutagenicity experiments.

A moderate emulsion was observed in the Petri plates when scoring the revertants at dose-levels > 2500 µg/plate.

No noteworthy toxicity was noted at any dose-levels in any of the five strains used.

The test item did not induce any noteworthy increase in the number of revertants, in any of the five strains.

Experiments with S9 mix.

The selected treatment-levels were:

. 312.5, 625, 1250, 2500 and 5000 µg/plate for the first and second mutagenicity experiments,

. 625, 1250, 1875, 2500, 3750 and 5000 µg/plate for the third experiment.

A moderate emulsion was observed in the Petri plates when scoring the revertants at dose-levels > 2500 µg/plate.

No noteworthy toxicity was noted at any dose-levels in any of the five strains used.

Slight increase in the number of revertants were observed in the TA 1535, TA 98 and TA 100 strains in the second experiment (preincubation method). Since they were neither observed in the first experiment using the direct plate incorporation method, no reproduced in the third confirmatory experiment using the preincubation method and a closer range of dose-levels, these increases were not considered as biologically relevant.

Under our experimental conditions, the test item URETHANE RESIN M2001 did not show any mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

The test item URETHANE RESIN M2001 did not show any mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium.