Registration Dossier

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data

Data source

Reference
Reference Type:
review article or handbook
Title:
BG Chemie - Potential Health Hazards of Existing Chemiclas (TOXIKOLOGISCHE BEWERTUNG zu Benzolsulfonsäurehydrazid, BG-Nr. 220)
Author:
Berufsgenossenschaft Rohstoffe und chemische Industrie (BG RCI)

Materials and methods

Principles of method if other than guideline:
salmonella/microsome test
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
S9-fraction from the liver of male Sprague-Dawley rats pretreated with Aroclor 1254
Test concentrations with justification for top dose:
up to 12500 µg/plate

Results and discussion

Test resultsopen allclose all
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
positive
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
positive
Additional information on results:
625 µg/plate was given as the lowest effective dose for TA 1535,
5000 µg/plate was given as the lowest effective dose for TA 100

Applicant's summary and conclusion