Registration Dossier

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)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Deviations:
no
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

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

Method

Species / strain
Species / strain / cell type:
other: TA1535, TA1537, TA100, TA98 and WP2uvrA
Metabolic activation:
with and without
Metabolic activation system:
Aroclor-1254 induced rat liver S9-mix
Test concentrations with justification for top dose:
dose range finding test: 3, 10, 33, 100, 333, 1000, 3330 and 5000 µg/plate with and without 5% S-9 mix.
experiment 1: 33, 100, 333, 1000, 3330 and 5000 µg/plate with and without 5% S-9 mix (TA100 and WP2uvrA also at 3 and 10 µg/plate).
experiment 2: 33, 100, 333, 1000, 3330 and 5000 µg/plate with and without 10% S-9 mix (TA100 also at 10 µg/plate).
experiment 3: TA100 at 100, 333, 1000, 3330, and 5000 µg/plate with S-9 mix
Vehicle / solvent:
Dimethyl sulfoxide
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
Dimethyl sulfoxide
True negative controls:
no
Positive controls:
yes
Positive control substance:
4-nitroquinoline-N-oxide
9-aminoacridine
sodium azide
methylmethanesulfonate
other: 2-aminoanthracene
Remarks:
other: daunomycin for TA98 without S-9 mix
Evaluation criteria:
A test substance is considered negative (not mutagenic) in the test if the total number of revertants is not higher than two times the solvent control value, with and without metabolic activation.
A test substance is considered positive (mutagenic) in the test if the total number of revertants is higher than two times the solvent control value, with and without metabolic activation. However, any mean plate count of less than 20 is considered to be not significant.

Results and discussion

Test results
Species / strain:
other: TA1535, TA1537, TA100, TA98 and WP2uvrA
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
1000 µg/plate TA100, 3330 µg/plate WP2uvrA
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 with metabolic activation
negative without metabolic activation

Under the conditions of this study the substance MMC was tested negative regarding mutagenic properties in the bacteria strains TA1535, TA1537, TA100, TA98 and WP2uvrA with and without metabolic activation.