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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: comparable to guideline study with acceptable restrictions (e.g. tester strains used and dose range selection were not in accordance with current guidelines)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976

Materials and methods

Principles of method if other than guideline:
other: ames assay
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
BIO-76-180 CP15255 Santocure MOR

Method

Target gene:
ames assay
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium, other: TA 1535, TA 1537, TA 1538, TA 98, TA 100
Species / strain / cell type:
yeast, other: Saccharomyces cerevisiae strain D4
Metabolic activation:
with and without
Metabolic activation system:
S9-mix
Test concentrations with justification for top dose:
0.1, 1, 10, 100, 500 µg/plate
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: -S9: MNNG, OM, NF; +S9: ANTH, AMQ, AAF, DMNA

Results and discussion

Test resultsopen allclose all
Species / strain:
E. coli, other: TA 1535, TA 1537, TA 1538, TA 98, TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: cytotoxicity at high dose range, low dose range on effects, no additional data available
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Species / strain:
yeast, other: Saccharomyces cerevisiae strain D4
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: cytotoxicity at high dose range, low dose range on effects, no additional data available
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Remarks on result:
other: strain/cell type: TA 1535, TA 1537, TA 1538, TA 98, TA 100
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

The test substance was negative in the ames assay and in the assay with Saccharomyces cerevisiae strain D4 with and without metabolic activation.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative