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:
other company data
Title:
Unnamed
Year:
2012
Report Date:
2012

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

Method

Species / strain
Species / strain / cell type:
bacteria, other: Salmonella typhimurium :TA98, TA100, TA102, TA1535 and TA1537
Metabolic activation system:
The post-mitochondrial fraction (S9) prepared from Aroclor 1254-induced Sprague-Dawley rats was purchased from MOLTOX, Molecular Toxicology Incorporated, USA (lot no. 2843, 38.9mg protein/mL and expiration date Oct. 13, 2013)
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 50, 150, 500, 1500 and 5000 µg/plate
Concentration range in the main test (without metabolic activation): 50, 150, 500, 1500 and 5000 µg/plate
Vehicle / solvent:
Solvent: DMSO
Controls
Untreated negative controls:
yes
Remarks:
DMSO
Positive controls:
yes
Positive control substance:
2-nitrofluorene
sodium azide
mitomycin C
other: Acridine mutagen ICR 191, 2-Aminofluorene, 2-Aminoanthracene

Results and discussion

Test resultsopen allclose all
Species / strain:
other: as specified above
Metabolic activation:
with
Genotoxicity:
not specified
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 5000 µg/plate)
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
other: as specified above
Metabolic activation:
without
Genotoxicity:
not specified
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 5000 µg/plate)
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
In the mutagenicity test, the tester cultures were exposed to Everzol SB44 at doses of 50, 150, 500, 1500 and 5000 μg/plate.
In addition, the negative control (DMSO) and strain-specific positive control for each strain, either in the presence or
absence of S9 metabolic activation were included. Results revealed that the mean colony numbers of negative controls of
five teater strains were eithin an acceptable range either in the presence or absence of S9 activation. The concurrent
strain-specific positive controls for TA1535 and TA1537 induced more than a three-fold increase in the number of revertants
over the negative control values, while positive controls for the rest of the three sreains, TA98,TA100 and TA102, induced
more than a two-fold increase. In addition, at least three analyzable doses were obtained in each tester strain. Therefore,
this studymet the criteria for a valid test.
No cytotoxicity was resulted from SB44 treatment at doses up to 5000 μg/plate in TA98, TA100, TA102, TA1535 and TA1537
tester strains. No precipitation was observed from SB44 treatment at doses up to 5000 μg/plate in TA98, TA100, TA102,
TA1535 and TA1537 tester strains. In the Salmonella reverse gene mutation assay, therewere no increases in the revertants
numbers at doses ranging from 50 to 5000 μg/plate of Everzol SB44 in all tester strains in the presence or absence of metabolic
activation when compared with the background spontaneous revertants.
Remarks on result:
other: other: preliminary test
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

It was concluded that under the test conditions, Everzol SB44 did not induce reverse mutation in five tester strains of Salmonella typhimurium either in the presence or absence of metabolic activation in vitro.