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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: No OECD study or GLP defined, only 4 Salmonella strains tested.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981

Materials and methods

Principles of method if other than guideline:
other: Ames assay
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Method

Target gene:
Ames assay: detection of base pair substitutions and frameshift mutations
Species / strain
Species / strain / cell type:
other: Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Test concentrations with justification for top dose:
up to 12500 ug/plate
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
not specified
True negative controls:
yes
Positive controls:
yes
Remarks:
s1) Endoxan (only TA 1535 and TA 100); 2) Trypaflavin (only 1537 and TA 98); 3) 2-Aminoanthrazen (only TA 1537 and TA 98)
Positive control substance:
other: Endoxan, Trypaflavin, 2-Aminoanthrazen
Details on test system and experimental conditions:
IUCLID4 Type: Ames test

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:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: other: Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

No references for a mutagen effect of Mesamoll could be found.

Applicant's summary and conclusion

Executive summary:

Mesamoll was tested in an Salmonella/microsome test in doses up to 12500 µg/plate (20; 100; 500; 2500; 12500 µg/plate) with 4 Salmonella typhimurium strains (TA 1535; TA 100; TA 1537 and TA 98).

Doses up to 12500 µg/plate did not lead to bacteriotoxic effects. The positive controls Endoxan, Trypaflavin and 2 -Aminoanthrazen reacted clearly mutagen.

No references for a mutagen effect of Mesamoll could be found.