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:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
1993
Reference Type:
secondary source
Title:
1993. Evaluation of mutagenicity testing with Salmonella typhimurium TA 102 in three different laboratories.
Author:
Müller W., Engelhardt G., Herbold B., Jäckh R., Jung R.
Year:
1993
Bibliographic source:
Environ Health Perspect, 101, 33-36; cited in ECETOC JACC, n-butanol, 2003
Reference Type:
secondary source
Title:
Collaborative study of mutagenicity with Salmonalla typhimurium TA 102.
Author:
Jung R., Engelhardt G., Herbolt B., Jäckh R., Müller W.
Year:
1992
Bibliographic source:
Mutat Res, 278, 265-270; cited in ECETOC JACC, n-Butanol, 2003

Materials and methods

Principles of method if other than guideline:
Ames test with S. typhimurium TA 102 as described by Maron and Ames (1983) and as specified for TA102 by D. Levin et al . (1982).
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- purity: highest purity available

Method

Target gene:
his-
Species / strain
Species / strain / cell type:
S. typhimurium TA 102
Metabolic activation:
with and without
Metabolic activation system:
S9 mix from livers of Aroclor 1254-induced Sprague-Dawley rats
Test concentrations with justification for top dose:
up to 5000 µg/plate
Details on test system and experimental conditions:
The compounds were tested in at least 2 independent experiments using 5 doses and 3 plates per dose.

Results and discussion

Test results
Species / strain:
S. typhimurium TA 102
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: up to limit dose or to precipitating or cytotoxic doses
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion