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Toxicological information

Genetic toxicity: in vitro

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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study design comparable to OECD Guideline 471/472. Study in Japanese without complete English translation.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
Deviations:
no
Principles of method if other than guideline:
Plate incorporation method; Study performed according to Guideline for Screening Mutagenicity Testing of Chemicals (Japan)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity: 99.6 %

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
S9 mix from rat liver (induction with phenobarbital and 5,6-benzoflavone)
Test concentrations with justification for top dose:
+/-S9 mix, all strains:
0, 12.5, 25, 50, 100, 200 or 400 ug/plate
Vehicle / solvent:
DMSO
Controls
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
Positive controls:
yes
Remarks:
see below
Positive control substance:
other: see below
Details on test system and experimental conditions:
3 plates/test
2 replicates

Positive controls:

-S9 mix:
TA 100, TA 98, E. coli WP2 uvrA: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide
TA 1535: Sodium azide
TA 1537: 9-aminoacridine

+S9 mix:
All strains: 2-aminoanthracene
Evaluation criteria:
according to OECD Guidelines No. 471 and 472
Statistics:
Yes

Results and discussion

Test resultsopen allclose all
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
Remarks:
>= 200 ug/plate (+/- S9)
Vehicle controls validity:
valid
Positive controls validity:
valid
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
>= 200 ug/plate (+/- S9)
Vehicle controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
negative E. coli WP2 uvr A

The TS was not mutagenic in Salmonella typhimurium TA 100, TA 1535, TA 98, TA 1537 and Escherichia coli WP2 uvrA, with or without an exogenous metabolic activation system.
Executive summary:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 as well as E. coli WP2 uvr A were tested in a plate incorporation assay with a study design comparable to OECD Guidelines No. 471 and 472.

The test concentrations were given as follows:

+/-S9 mix, all strains:

0, 12.5, 25, 50, 100, 200 or 400 ug/plate

Cytotoxic effects in all strains were seen at >= 200 ug/plate (+/- S9).

The TS was not mutagenic in Salmonella typhimurium TA 100, TA 1535, TA 98, TA 1537 and Escherichia coli WP2 uvrA, with or without an exogenous metabolic activation system.