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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)
Rationale for reliability incl. deficiencies:
other: GLP guideline study with minor restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Test substance: 625-Triketone
- Test substance No.: 95/225-1
- CAS No.: 94723-86-1
- Batch No.: LJ 27 881/1
- Date of manufacturing: July 18 - 27, 1995
- Degree of purity: 99.4%
- Appearance, consistency: Beige powder
- Storage: Refrigerator

Method

Target gene:
histidine operon and tryptophan operon
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
rat liver S9 mix (Aroclor 1254-induced)
Test concentrations with justification for top dose:
0; 20; 100; 500; 2500 and 5000 µg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
Controlsopen allclose all
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2.5 µg (S.typhimurium) or 60 µg (E.coli) 2-aminoanthracene in DMSO
Remarks:
with S-9 mix
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
N-ethyl-N-nitro-N-nitrosoguanidine
Remarks:
without S-9 mix; for strains TA100 and TA1535

Migrated to IUCLID6: 5 µg in DMSO
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 10 µg 4-nitro-o-phenylendiamine in DMSO
Remarks:
without S-9 mix for strain TA98
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
9-aminoacridine
Remarks:
without S-9 mix for strain TA1537

Migrated to IUCLID6: 100 µg in DMSO
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
N-ethyl-N-nitro-N-nitrosoguanidine
Remarks:
without S-9 mix for E.coli Wp2 uvrA

Migrated to IUCLID6: 10 µg in DMSO
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (standard plate test)
DURATION
- Growth/exposure period: 48-72 h, in the dark; with addition of S-9 or phosphate buffer, respectively

METHOD OF APPLICATION: preincubation test
DURATION
- Preincubation period: 20 min, with addition of S-9 mix if required
- Growth/exposure period: 48-72 h, in the dark

GROWTH MEDIA:
- S.typhimurium: Vogel-Bonner E medium + 20 g/L D-glucose
- E.coli: SAI selective agar

NUMBER OF COLONIES EVALUATED: all revertant colonies

DETERMINATION OF CYTOTOXICITY
- Method: reduced his- background growth, decrease in the number of his+ revertants, titer determination

ANALYSIS OF BACTERIA STRAINS:
- The Salmonella strains are checked for the following characteristics at regular intervals: deep rough character (rfa); UV sensitivity (A uvrB); ampicillin resistance (R factor plasmid). Histidine and tryptophan auxotrophy is automatically checked in each experiment via the spontaneous rate.

OTHER:
- Three test replications per dose were performed.
Evaluation criteria:
In general, a substance to be characterized as positive in the bacterial tests has to fulfill the following requirements:
- doubling of the spontaneous mutation rate (control)
- dose-response relationship
- reproducibility of the results.

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
≥ 2500 µg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
≥ 2500 µg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Additional information on results:
TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No test substance specific precipitations
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Under the chosen test conditions, 625 -Triketone is not mutagenic in bacteria.

Applicant's summary and conclusion