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Toxicological information

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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Malonic acid was negative for mutagenicity in a bacterial reverse mutation assay. The structurally realted substance disodium succinate, which is used as an analog for succinic acid, was also negative in a bacterial reverse mutauton assay, and in a mammalian chromosomal aberration study. Glutaric acid, another dicarboxylic acid was also negative in a bacterial reverse mutation assay and a mouse micronucleus test. Although positive results for glutaric acid were obtained in a cell transformation assay and a mouse lymphoma assay, these positive results were thought to be due to a pH dependent effect upon the culture medium.

Link to relevant study records
Reference
Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Justification for type of information:
Data from reliable peer reviewed body.
Guideline:
other: US NTP Standard Protocol
Principles of method if other than guideline:
The study was carried out using the NTP standard published protocol
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay
Species / strain / cell type:
S. typhimurium, other:
Remarks:
TA100, TA1535, TA97, TA98
Metabolic activation:
with and without
Metabolic activation system:
Induced male Sprague Dawley rat liver S9 or induced male Syrian hamster liver S9
Test concentrations with justification for top dose:
ug/Plate  0, 33, 100, 333, 1000, 3333 
Vehicle / solvent:
Water
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
not applicable
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
not applicable
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 97
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
not applicable
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
not applicable
Untreated negative controls validity:
valid
Positive controls validity:
valid

Strain: TA100
Dose No Activation No Activation 30% RLI 30% HLI 10% RLI 10% HLI
(Negative) (Negative) (Negative) (Negative) (Negative) (Negative)
Protocol Preincubation Preincubation Preincubation Preincubation Preincubation Preincubation
ug/Plate Mean ±SEM Mean ±SEM Mean ±SEM Mean ±SEM Mean ±SEM Mean ±SEM
 0          141 3.3 129 9 183 8.4 154 4.4 164 5 142 7
33          142 2.4 128 8.5 165 19.1 131 7.7 167 3.1 149 7.3
100          134 1.7 131 17.1 208 1.3 146 9.2 168 3.5 145 2.7
333          125 2.5 138 7.2 165 9.9 145 21.2 170 7.4 138 7.2
1000          115 0.3 116 4.6 148 6.9 146 10.4 152 5 137 7.2
3333          86 3.1 116 6.2 120 p  12.8 118 p  23.2 157 p  11.9 126 p  13.7
Positive Control 764 25.4 1136 15.4 406 10.5 557 16.2 461 20.2 826 49.8
Strain: TA1535
Dose No Activation No Activation 30% RLI 30% HLI 10% RLI 10% HLI
(Negative) (Negative) (Negative) (Negative) (Negative) (Negative)
Protocol Preincubation Preincubation Preincubation Preincubation Preincubation Preincubation
ug/Plate Mean ±SEM Mean ±SEM Mean ±SEM Mean ±SEM Mean ±SEM Mean ±SEM
 0          10 2.2 5 0.7 14 0.9 9 2.6 10 0.9 8 2.3
33          10 2.1 5 0.9 12 0.9 9 2.1 10 1 6 2
100          8 2.3 7 1.2 11 2.2 11 1.5 5 1.5 10 1.2
333          5 1.7 6 0.3 11 0.9 7 1.9 9 1.5 8 0.7
1000          6 1.2 7 1.5 11 1.7 8 0.3 6 0.3 9 1.2
3333          6 0.7 6 0.9 11 0.7 9 0.3 6 1.2 8 1.2
Positive Control 1039 62.5 1198 86.2 67 3.2 199 20.6 75 5.8 95 4.3
Strain: TA97
Dose No Activation No Activation 30% RLI 30% HLI 10% RLI 10% HLI
(Negative) (Negative) (Negative) (Negative) (Negative) (Negative)
Protocol Preincubation Preincubation Preincubation Preincubation Preincubation Preincubation
ug/Plate Mean ±SEM Mean ±SEM Mean ±SEM Mean ±SEM Mean ±SEM Mean ±SEM
 0          162 7 155 8.7 222 2.6 168 4 191 3.4 150 6.5
33          164 11.9 172 3.2 221 7.2 172 3.2 200 2.4 158 12.8
100          167 15.9 173 8 204 7.2 180 2.9 175 13.7 156 10.7
333          180 8.4 160 17 229 10.6 172 9 200 6.3 158 16.9
1000          154 5.7 127 5.6 225 11.3 167 8.7 181 5.6 151 6.1
3333          133 3.8 137 8.8 148 p  6.9 146 p  5 160 p  4 119 p  7.2
Positive Control 395 7.5 373 35.4 310 6 316 10.3 325 6.2 412 18.3
Strain: TA98
Dose No Activation No Activation 30% RLI 30% HLI 10% RLI 10% HLI
(Negative) (Negative) (Negative) (Negative) (Negative) (Negative)
Protocol Preincubation Preincubation Preincubation Preincubation Preincubation Preincubation
ug/Plate Mean ±SEM Mean ±SEM Mean ±SEM Mean ±SEM Mean ±SEM Mean ±SEM
 0          20 1.8 15 1.2 15 2 20 2.5 34 7 24 2
33          21 2.8 19 4 14 1.2 21 1.7 35 1 22 4.2
100          19 2.3 23 2.2 13 1.5 20 2.6 30 2.8 20 2.7
333          19 3.2 16 2.1 13 1.5 20 3.7 18 0.9 21 2.6
1000          16 2.3 18 2.1 4 1.2 13 2.4 21 2 21 2
3333          17 1.7 17 2.8 5 1.2 8 x  2.6 21 p  1.2 18 p  0.3
Positive Control 564 4.9 601 18.2 114 6 581 33.5 241 9.7 560 34.6
Abbreviations:
RLI = induced male Sprague Dawley rat liver S9
HLI = induced male Syrian hamster liver S9
s = Slight Toxicity; p = Precipitate; x = Slight Toxicity and Precipitate; t = Toxic; c = Contamination
Conclusions:
Malonic acid was negative in a bacterial mutagenicity study, with and without metabolic activation.
Executive summary:

Malonic acid was tested in a bacterial mutagenicicty study according to standard NTP protocols. The results in all strains and at all concentrations were negative, with and without metabolic activation.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Justification for classification or non-classification