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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
Study period:
October - December, 2010
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Qualifier:
according to
Guideline:
EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
Qualifier:
according to
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
GLP compliance:
yes (incl. certificate)
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name. 1,2-dichloropropane
Storage: room temperature
Purity: 99.59%
Description: clear liquid

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Test concentrations with justification for top dose:
in TA98 at 5000 and 1581 μg/plate (-S9 Mix); 5000 μg/plate (+S9 Mix)
in TA100 at 5000 and 1581 μg/plate (-S9 Mix); 5000 μg/plate (+S9 Mix)
in TA1535 at 5000 and 1581 μg/plate (-S9 Mix); 5000 μg/plate (+S9 Mix)
in TA1537 at 5000 and 1581 μg/plate (-S9 Mix); 5000 μg/plate (+S9 Mix)
in E. coli WP2 uvrA at 5000 μg/plate (±S9 Mix)
Vehicle / solvent:
Dimethyl sulfoxide (DMSO) and distilled water.
Controls
Untreated negative controls:
yes
Remarks:
Dimethyl sulfoxide (DMSO); Distilled water:
Positive controls:
yes
Remarks:
4-nitro-1,2-phenylene-diamine ; Sodium azide; 9-aminoacridine; Methyl-methanesulfonate; 2-aminoanthracene

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 / choice of top concentrations:
no cytotoxicity
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with and without metabolic activation

The test item 1,2-Dichloropropane had no mutagenic activity on the growth of the applied bacterium tester strains under the test conditions used in this study.