Registration Dossier

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

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: meets generally accepted scientific standards, acceptable for assessment

Data source

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

Materials and methods

Principles of method if other than guideline:
Standard NTP protocol
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no data

Method

Species / strain
Species / strain / cell type:
other: Salmonella typhimurium TA100, TA98
Metabolic activation:
with and without
Metabolic activation system:
induced male Sprague Dawley rat liver S9 (RLI) or induced male Syrian hamster liver S9 (HLI)
Test concentrations with justification for top dose:
0, 0.3, 1, 3, 10, 33, 100, 333, 1000, 3333, 10000 mg/plate
Vehicle / solvent:
no data
Details on test system and experimental conditions:
Ames test
Evaluation criteria:
no data
Statistics:
no data

Results and discussion

Test results
Species / strain:
S. typhimurium, other: TA100, TA98
Metabolic activation:
with and without
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
other: 1000 µg/plate
Additional information on results:
In this study it was clearly shown that the number of reverse mutations increased in the strain TA100 with increasing amounts of the test substance. Using 10 µg/plate of the test substance the number of reverse mutations was about 3-fold (without activation) and 4.4-fold (30%RLI) or 5-fold (30%HLI) higher than in the control.
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Some representative results are shown in the following tables: 
Strain: TA100
Dose(µg/plate)
No activation
30% RLI
30%HLI
0
97
103
105
0.3
91
108
not tested
1
113
169
not tested
3
158
254
not tested
10
314
451
529
33
553
708
701
 
Strain: TA98
Dose(µg/plate)
No activation
30% RLI
30%HLI
0
22
22
26
10
20
21
25
33
21
20
27
100
22
20
31
333
26
31
27
1000
22 (slight tox)
25 (slight tox)
31
 


Applicant's summary and conclusion