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:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: short abstract

Data source

Reference
Reference Type:
publication
Title:
Acute toxicologic evaluation of aldadiene
Author:
McLain DE et al.
Year:
1990
Bibliographic source:
J. American College Toxicology, Part B. Vol. 1, pp. 36-37, 1990

Materials and methods

Principles of method if other than guideline:
no data
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Method

Target gene:
Histidine gene locus
Species / strain
Species / strain / cell type:
S. typhimurium, other: TA 98, TA 100, TA 1535, TA 1537 and TA 1538
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
no data
Test concentrations with justification for top dose:
16.7 - 3330 µg/plate
Vehicle / solvent:
no data
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
not specified
Details on test system and experimental conditions:
no data
Evaluation criteria:
no data
Statistics:
no data

Results and discussion

Test results
Species / strain:
S. typhimurium, other: TA 98, TA 100, TA 1535, TA 1537 and TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
in all strains at 1670 and 3330 µg/plate
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Executive summary:

The mutagenic potential of the test substance was evaluated in a Salmonella/microsome test with the S. typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and TA 1538 in the presence and absence of S9 mix. Evidence of mutagenic activity was not seen up to the maximum dose level of 3330 µg/plate. Cytotoxic effects were observed at 1670 and 3330 µg/plate in all strains. In addition, the test substance percipitated at these concentrations.