Registration Dossier

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: Basic data given

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1991

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Ames test using Salmonella typhimurium strains TA100 and TA98 with and without metabolic activation (S9 rat or hamster) was performed.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): (E)-1,4-Dibromo-2-butene

Method

Target gene:
his
Species / strain
Species / strain / cell type:
other: Salmonella typhimurium strans TA100 and TA98
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
induced male Sprague Dawley rat liver S9 and induced male Syrian hamster liver S9
Test concentrations with justification for top dose:
0, 0.1, 0.3, 1, 3.3, 10, 20, 33, 50, 67, 75, 100 µg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
not specified
Details on test system and experimental conditions:
METHOD OF APPLICATION: preincubation

DURATION
- No data

SELECTION AGENT (mutation assays):
- No data

NUMBER OF REPLICATIONS:
- No data

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth

METABOLIC ACTIVATION
- 30 % induced male liver S)

Evaluation criteria:
No data
Statistics:
No data

Results and discussion

Test results
Species / strain:
other: TA100 and TA98
Metabolic activation:
with and without
Genotoxicity:
positive
Remarks:
data see attached Table
Cytotoxicity / choice of top concentrations:
other: 100 µg/plate is slightly toxic
Vehicle controls validity:
not specified
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
No data
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):
positive

The test substance trans-1,4 -Dibromo-2 -butene is positive in Salmonella typhimurium strains TA100 and TA98.