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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Results of an study conducted in accordance with generally accepted scientific principles. Possible deficiencies in the reporting of the endopoint do not affect the quality of relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Qualifier:
according to
Guideline:
OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Commercial purity: 97.2%

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
Species / strain / cell type:
other: S. Typhimirium TA 1539
Metabolic activation:
with and without
Metabolic activation system:
Liver S-9 fraction from Phenobarbital and 5,6-benzoflavone pretreated male SD rats with NADPH-generating system.
Test concentrations with justification for top dose:
0, 2.4-78.12 µg/plate
Details on test system and experimental conditions:
Procedure: pre-incubation
Plates/test: 3
Media: Histidine selective
Number of replicates: 2

Results and discussion

Test results
Species / strain:
other: as described above
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
50 µg/plate
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 without metabolic activation
negative with metabolic activation
Executive summary:

Reverse gene mutation assays were conducted in line with Guidelines for Screening Mutagenicity Testing of Chemicals (Japan) and OECD Test Guidelines 471 and 472, using the pre-incubation method. This study was well controlled and regarded as a key study.

1,4 -diethylbenzene showed negative results in Salmonella Typhimurium TA100, TA1535, TA98, TA1537 and Eschirichia Coli WP2 uvrA at concentrations up to 50 µg/plate with or without metabolic activation (MHW, 1993c)