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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Screening procedures for the experimental cancer chemotherapy
Author:
Szybalski W
Year:
1958
Bibliographic source:
Ann. N.Y. Acad. Sci. 76 (3), 475-489
Reference Type:
secondary source
Title:
No information
Author:
RIFM
Year:
2009
Bibliographic source:
RIFM database

Materials and methods

Principles of method if other than guideline:
paper-disk method acc. to Iyer VN. and Szybalski W, Appl. Microbiol. 6, 23-29, 1958
GLP compliance:
no
Type of assay:
bacterial gene mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): n-amyl alcohol

Method

Target gene:
streptomycin dependence
Species / strain
Species / strain / cell type:
other: Escherichia coli Sd-4-73
Additional strain / cell type characteristics:
not specified
Metabolic activation:
without
Test concentrations with justification for top dose:
10 - 25 µl/plate (paper-disk-method)
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: several concurrent positive experiments
Details on test system and experimental conditions:
METHOD OF APPLICATION: as impregnation on paper disk


DURATION
- Preincubation period: overnight culture

SELECTION AGENT (mutation assays): Streptomycin

Results and discussion

Test results
Species / strain:
other: Escherichia coli Sd-4-73
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
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

Conclusions:
Interpretation of results (migrated information):
negative