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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
Study period:
22/4/1994
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
not specified
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Method

Target gene:
Histidine
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:
Hepatic post-microbial fraction (S9)
Test concentrations with justification for top dose:
50, 150, 500, 1500, 5000mcg/plate
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
Migrated to IUCLID6: and ICR-191, 2-Aminoanthracene, 2-Nitroflurene, Dandron, Mitomycin C, Neutral red

Results and discussion

Test results
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:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

GR101030X was not mutagenic in the test strains studied.
Executive summary:

GR101030X showed no evidence of mutagenicity in the bacterial tes systems used in this study. Ames and liquid pre-incubation (Yahagi) assays were carried out up to the maximum concentration of 5000mcg/plate (using Salmonella typhimurium TA1535, TA1537, TA98, TA100 and TA102). The Ames tests were carried out in the absence and presence of a rat liver S9 mix. The liquid pre-incubation test (Yahagi) assay was carried out in the presence of S9-mix only

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