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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: GLP and OECD Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Qualifier:
according to
Guideline:
other: 92/69/EWG, B.14 (Ames-Test)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
purity: 99.66%

Method

Target gene:
Ames assay
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Metabolic activation system:
S9-Mix mit 10 % S9 Fraktion von Aroclor induzierten männlichen Sprague Dawley Ratten "ENGLISH" S9 mix with 10 % S9 fraction of Aroclor 1254 induced male Sprague Dawley rats.
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 50, 158, 500, 1581, 5000 µg/plate
Concentration range in the main test (without metabolic activation): 50, 158, 500, 1581, 5000 µg/plate
Vehicle / solvent:
Solvent: DMSO
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
yes
Positive controls:
yes
Positive control substance:
other: Na-azide, NF, 4-NPDA, Cumene, 2-AA
Details on test system and experimental conditions:
Concentration of the test substance resulting in precipitation: 1581 µg/plate and higher.
Evaluation criteria:
Postive controls: sodium azide, nitrofurantoin, 4-nitro-1,2-phenylene diamine, cumene hydroperoxide, 2-aminoanthracene increased mutant counts to well over those of the negative control, and thus demonstrated the system's sensitivity and the activity of the S9 mix

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
Observations: None


"ENGLISH"

none

Any other information on results incl. tables

Vulcuren VP KA 9188 was considered to be non-mutagenic with and without metabolic activation in the plate incorporation as well as in the preincubation modification of the Salmonella/microsome test.

Precipitation of the test substance: 1581 µg/plate and higher.

Applicant's summary and conclusion

Conclusions:
Interpretation of results: negative with and without metabolic activation.
Executive summary:

Vulcuren VP KA 9188 was considered to be non-mutagenic with and without metabolic activation in the plate incorporation as well as in the preincubation modification of the Salmonella/microsome test. No bacteriotoxic effects were seen in any of the dose groups evaluated (Bayer 2000a).