Registration Dossier

Diss Factsheets

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)

Data source

Reference
Reference Type:
secondary source
Title:
IUCLID DATAFILE
Author:
unknown
Year:
2000
Bibliographic source:
Esis-Database, European Chemicals Bureau

Materials and methods

Test guideline
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
3,5-dichloronitrobenzene
EC Number:
210-557-3
EC Name:
3,5-dichloronitrobenzene
Cas Number:
618-62-2
Molecular formula:
C6H3Cl2NO2
IUPAC Name:
3,5-dichloronitrobenzene

Method

Species / strain
Species / strain / cell type:
bacteria, other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
S9 rat liver
Test concentrations with justification for top dose:
12,5; 25; 50; 100; 200

Results and discussion

Test results
Species / strain:
E. coli, other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
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

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