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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Ames et al. (1975) Methods for detecting carcinogens ansd mutagens with the Salmonella/mammalian-microsome mutagenicity test, Mutation Res., 31, 347-364. Revised 1981
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium maleate dihydrate
Cas Number:
53172-74-0
Molecular formula:
C4H6Na2O6
IUPAC Name:
Disodium maleate dihydrate

Method

Species / strain
Species / strain / cell type:
S. typhimurium, other: TA1535, TA1537, TA1538, TA98, TA100
Metabolic activation:
with and without
Metabolic activation system:
Aroclor-1254-induced male rat liver microsomal enzymes
Test concentrations with justification for top dose:
938, 1875, 3750, 7500, 15000 µg/plate
Vehicle / solvent:
Oxoid nutrition broth No. 2
Controls
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
9-aminoacridine
2-nitrofluorene
sodium azide

Results and discussion

Test results
Key result
Species / strain:
S. typhimurium, other: TA1535, TA1537, TA1538, TA98, TA100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
The substance induced no consistently dose-related increases in his+ revertants. At the highest delivered dose the substance was not cytotoxic.
Executive summary:

The mutagenic potential of the substance was investigated in the standard Ames/Salmonella/mammalian microsome assay in the presence and absence of Aroclor-1254 -induced rat liver S 9. The substance proved to be non-mutagenic.