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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: Adopted according to OECD SIDS (publicly available peer reviewed source). Original document not available.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1992
Reference Type:
secondary source
Title:
SIDS Initial Assessment Report For SIAM 20 (Malonic Acid Diesters: Dimethylmalonate, 108-59-8; Diethylmalonate, 105-53-3), April 19-22, 2005 Paris.
Author:
OECD SIDS
Year:
2005
Bibliographic source:
UNEP Publications

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Deviations:
yes
Remarks:
Use of 4 Salmonella typhimurium strains instead of 5 strains, as cited in the actual test requirements (OECD TG 471, adopted 1997)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity: ca. 99 %
Impurities from the production process: methanol (ca. 0.3 %) and dimethyl-methylmalonate (ca. 0.2%)
Physical state: liquid, colorless

Method

Target gene:
his operon
Species / strainopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
Phenobarbiturate-induced rat liver S9 fraction of male Wistar rats
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Metabolic activation system:
Phenobarbiturate-induced rat liver S9 fraction of male Wistar rats
Test concentrations with justification for top dose:
8-5000 µg/plate
Controls
Negative controls:
not specified
Solvent controls:
not specified
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: Positive control substances: Without S9: TA 98, 1538: Nitrofluorene TA 100, 1535: Sodium azide TA 1537: Aminoacridine With S9: Cyclophosphamide (TA 100 only)
Details on test system and conditions:
METHOD OF APPLICATION: 2 independent assays, one plate incorporation, one pre-incubation test.

DURATION
- Preincubation period: 30 min

NUMBER OF REPLICATIONS: 3 replicates
Statistics:
Mean values and standard deviation were calculated with BIOSYS software.

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
yes
Remarks:
>=1000 µg/plate
Vehicle controls valid:
not specified
Negative controls valid:
not specified
Positive controls valid:
not specified
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
yes
Remarks:
>=1000 µg/plate
Vehicle controls valid:
not specified
Negative controls valid:
not specified
Positive controls valid:
not specified
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
Additional information on results:
TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: no precipitation occurred

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative