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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)

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Report date:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: EEC 84/449 B4
GLP compliance:
yes
Type of assay:
bacterial gene mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Itaconic acid
EC Number:
202-599-6
EC Name:
Itaconic acid
Cas Number:
97-65-4
Molecular formula:
C5H6O4
IUPAC Name:
2-methylidenebutanedioic acid

Method

Species / strain
Species / strain / cell type:
S. typhimurium, other: TA 1535, TA 1537, TA 1538, TA 98 and TA 100
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
Liver preparation from Aroclor 1254-induced rats (S9 mix)
Test concentrations with justification for top dose:
Itaconic acid was dissolved in water and dose levels used in the main assays were: 100, 500, 1000, 1500 and 2000 µg/plate without S9 mix and 100, 500, 1000, 2500 and 5000 µg/plate in presence of S9 mix.

Results and discussion

Test results
Species / strain:
S. typhimurium, other: TA 1535, TA 1537, TA 1538, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Minimum concentration of test substance at which toxicity to bacteria was observed:

with metabolic activation : slightly toxic to TA 98 at 2500 ug/plate     

 without metabolic activation : highly toxic to TA 100 and TA 98 at 5000 ug/plate

Applicant's summary and conclusion