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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:
1998
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
non GLP; content not given
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified

Method

Target gene:
Histidine biosynthesis
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Test concentrations with justification for top dose:
Negative control
C.I. Direct Blue 264: 5000, 1581, 500, 158, 50, 16 µg/plate
Positive controls:
Na-azide: 10 µg/plate (TA1535)
Nitrofurantoin: 0.2 µg{plate (TA100)
4-nitro-1,2-phenylene diamine: 10 µg/plate (TA1537); 0.5 µg/plate (TA98)
Cumene: 50 µg/plate (TA102)
2-Aminoanthracene: 3 µg/plate

Due to precipitation of the substance, doses ranging from 100 to 3200µg/tube were chosen for the repeat tests.
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
yes
Positive controls:
yes
Positive control substance:
sodium azide
cumene hydroperoxide
other: nitrofurantoin, 4-nitro-1,2-phenylene diamine, 2-aminoantracene

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:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested

Any other information on results incl. tables

No bacteriotoxic effects up to 158 µg/plate; total bacterial count remained unchanged an no growth inhibition was seen.

At doses above 158 µg/plate strain-specific cytotoxicity.

Compound precipitation started at 500 µg/plate; and 5000 µg/plate could not be used for evaluation.

Applicant's summary and conclusion

Conclusions:
Interpretation of results: negative
Executive summary:

No evidence of mutagenic activity in plate incorporation test and preincubation test in the presence and absence of S9 mix.