Maleic acid

Genetic toxicity: in vitro

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: well documented study, a reliability of 2 is assigned

Data source

Reference

Reference Type:

publication

Title:

Nonmutagenicity of maleic acid and its sodium salts in Salmonella assays

Author:

Lake RS, DeVito GL, Szot RJ, Schwartz E

Year:

1988

Bibliographic source:

Mutation Research 207: 1-5

Materials and methods

Principles of method if other than guideline:

According to Ames et al. (1975, revised 1981) and Maron et al. (1983).

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Maleic acid

EC Number:

203-742-5

EC Name:

Maleic acid

Cas Number:

110-16-7

Molecular formula:

C4H4O4

IUPAC Name:

but-2-enedioic acid

Details on test material:

Maleic acid, from EM Sciences, Darmstadt, no data on purity

Method

Target gene:

his-

Species / strain

Species / strain / cell type:

other: Salmonella typhimurium TA98, TA100, TA1535, TA1537, TA1538

Metabolic activation:

with and without

Metabolic activation system:

Aroclor-1254-induced male rat liver S9 mix

Test concentrations with justification for top dose:

0 - 7500 µg/plate (4 dose groups)

Vehicle / solvent:

nutrient broth

Controls

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

other: see below

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

NUMBER OF REPLICATIONS: 3

POSITIVE CONTROLS:
TA 1535 NaAz 5.00 µg/p1ate - S9, 2-AA 2.5 µg/plate + S9;
TAI00 NaAz 5.00 µg/plate - S9, 2-AA 2.5 µg/pIate +S9;
TA 1537 NaAz 75.00 µg/plate -S9, 2-AA 2.5 µg/plate +S9;
TA1538 2-NF 5.00 µg/plate -S9, 2-AA 2.5 µg/plate +S9;
TA98 2-NF 5.00 µg/plate - S9, 2-AA 2.5 µg/pIate + S9

Statistics:

Treatment-related effects and dose-response trends were calculated using the statistical model of Snee and Irr (1984).

Results and discussion

Test results

Species / strain:

other: Salmonella typhimurium TA98, TA100, TA1535, TA1537, TA1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: > 7500 µg/plate

Vehicle controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Maleic acid dose levels above 7.5 mg/plate were highly cytotoxic; at doses as high as 7.5 mg/plate, initial pH was as low as 2.4; according to  the authors, no dose-related or statistically significant changes were observed.