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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
Study period:
From 30 May 2012 to 1 June 2012
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: 3a: Documentation insufficient for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
No reference guideline available.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Medoxomyl chloride (SAR408579)
- Lot/batch No.: D136Y82T

Method

Target gene:
Histidine
Species / strainopen allclose all
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Metabolic activation system:
S9-mix
Species / strain:
other: Mixed strains TA7001 - 7006
Metabolic activation:
with and without
Metabolic activation system:
S-9 mix
Test concentrations with justification for top dose:
0, 16, 50, 160 , 500, 1600 and 5000 µg/ml with and without metabolic activation
Controls
Negative controls:
yes
Remarks:
DMSO
Positive controls:
yes
Positive control substance:
4-nitroquinoline-N-oxide
2-nitrofluorene
other: 2-aminoanthracene

Results and discussion

Test resultsopen allclose all
Species / strain:
other: TA7001 - 7006 series of Salmonella
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity:
yes
Remarks:
at 1600 µg/ml and above
Vehicle controls valid:
yes
Negative controls valid:
yes
Positive controls valid:
yes
Species / strain:
other: TA7001 - 7006 series of Salmonella
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity:
yes
Remarks:
at 5000 µg/ml and above
Vehicle controls valid:
yes
Negative controls valid:
yes
Positive controls valid:
yes
Species / strain:
S. typhimurium TA 98
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity:
yes
Remarks:
at 500 µg/ml and above
Vehicle controls valid:
yes
Negative controls valid:
yes
Positive controls valid:
yes
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity:
yes
Remarks:
at 1600 µg/ml and above
Vehicle controls valid:
yes
Negative controls valid:
yes
Positive controls valid:
yes

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

The substance is considered to be not mutagenic in a bacterial reverse mutation test under the test conditions.