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Toxicological information

Genetic toxicity: in vitro

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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)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Salmonella typhirium, Reverse mutation assay, OECD No 471, 1983, and Annex to 92/69/EEC 31/7 92 part B.14.

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Target gene:
Operon gene for synthesis of amino acid histidine.
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 100
Details on mammalian cell type (if applicable):
- Type and identity of media: DMSO solvent
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes checked for R-factor plasmid pKM 101. Presence were checked with the resistance to strains of amipenicillin.
- Periodically checked for karyotype stability: rfa mutation was checked by testing the strains to toxic effect of crystal violet.
- Periodically "cleansed" against high spontaneous background: no data
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
S. typhimurium TA 98
Details on mammalian cell type (if applicable):
- Type and identity of media: DMSO solvent
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes checked for R-factor plasmid pKM 101. Presence were checked with the resistance to strains of amipenicillin.
- Periodically checked for karyotype stability: rfa mutation was checked by testing the strains to toxic effect of crystal violet.
- Periodically "cleansed" against high spontaneous background: no data
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
S. typhimurium TA 1537
Details on mammalian cell type (if applicable):
- Type and identity of media: DMSO solvent
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes checked for R-factor plasmid pKM 101. Presence were checked with the resistance to strains of amipenicillin.
- Periodically checked for karyotype stability: rfa mutation was checked by testing the strains to toxic effect of crystal violet.
- Periodically "cleansed" against high spontaneous background: no data
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
S. typhimurium TA 1535
Details on mammalian cell type (if applicable):
- Type and identity of media: DMSO solvent
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes checked for R-factor plasmid pKM 101. Presence were checked with the resistance to strains of amipenicillin.
- Periodically checked for karyotype stability: rfa mutation was checked by testing the strains to toxic effect of crystal violet.
- Periodically "cleansed" against high spontaneous background: no data
Additional strain / cell type characteristics:
not specified
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): CA 310 ... CA 5000 µg/plate
Concentration range in the main test (without metabolic activation): CA 310 ... CA 5000 µg/plate

Results and discussion

Test resultsopen allclose all
Species / strain:
other: as specified above
Metabolic activation:
with
Genotoxicity:
negative
Remarks:
as specified above
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 5000 µg/plate)
Vehicle controls validity:
valid
Untreated negative controls validity:
not valid
Positive controls validity:
valid
Species / strain:
other: as specified above
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 5000 µg/plate)
Vehicle controls validity:
valid
Untreated negative controls validity:
not valid
Positive controls validity:
valid
Species / strain:
other: as specified above
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 5000 µg/plate)
Vehicle controls validity:
valid
Untreated negative controls validity:
not valid
Positive controls validity:
valid
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion