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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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
Neither E.coli WP2 strains nor S. typhimurium TA102 were used.
GLP compliance:
yes (incl. certificate)
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
Trade name: Marliapl 1618/1

Method

Target gene:
His-operon
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Test concentrations with justification for top dose:
Plate incorporation: 0, 50, 160, 500, 1600, 5000 µg/plate
Preincubation (Test 1): 0, 50, 150, 300, 900, 1500 µg/plate
Preincubation (Test 2): 0, 10, 25, 50, 100, 150 µg/plate
Vehicle / solvent:
acetone
Controls
Untreated negative controls:
yes
Remarks:
untreated cells
Negative solvent / vehicle controls:
yes
Remarks:
acetone
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: +S9: 2-aminoanthracene (2.5 µg/plate); -S9: sodium azide (TA100 (5 µg/plate), TA1535 (2.5 µg/plate)), 2-nitrofluorene (TA98; 2.5 µg/plate), 9-aminoacridine (TA1537; 40 µg/plate)
Details on test system and experimental conditions:
METHOD OF APPLICATION: plate incorporation & preincubation
Evaluation criteria:
According to Guideline.

Results and discussion

Test results
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
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
negative