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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:
key study
Study period:
12 - 21 Jun 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
no E. Coli or S typhimurium TA 102 was used

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Method

Target gene:
uvrB
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:
S9-Mix rat and hamster
Test concentrations with justification for top dose:
Concentration range in the main test (with and without metabolic activation): 8, 40, 200, 1000, 5000 µg/plate
Vehicle / solvent:
Solvent: EtOH
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
sodium azide
congo red
other: Sodium azide; Nitrofurantoin; 4-nitro-1,2-phenylendiamine; 2-aminoanthracene; benzidine

Results and discussion

Test results
Species / strain:
other: TA 1535, TA 100, TA 1537, TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
starting from >= 5000 µg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
The positive controls sodium azide, nitrofurantoin, 4-nitro-1,2-phenylene diamine and 2-aminoanthracene increased mutant counts to well over those of the negative controls, and thus demonstrated the system's sensitivity and the activity of the S9 mix.
Remarks on result:
other: plate incorporation method

Any other information on results incl. tables

Substance precipiation occurring from >= 1000 µg/plate

Applicant's summary and conclusion

Conclusions:
The test item was found to be non mutagenic in an OECD 471 neither in presence nor in absence of a metabolic activation system. The Prival modification assay proved the results of the plate incorporation method. Hence, the test item is considered non mutagenic in bacteria.
Executive summary:

The Salmonella/microsome test, modified according to Prival and Mitchell and employing doses up to 5000 µg per tube, showed the test item not to produce bacteriotoxic effects. Substance precipitation occurred from 1000 µg per tube and above.In agreement with the plate incorporation assay, evaluation of individual dose groups of the preincubation assay according to Prival and Mitchell, with respect to relevant assessment parameters (dose effect, reproducibility), revealed no biologically relevant variations from the respective negative controls. The test item was found to be non mutagenic in an OECD 471 neither in presence nor in absence of a metabolic activation system.