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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: according to guideline and GLP, no preincubation method used.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): TETRAHYDROGERANIOL
- Physical state: liquid, pale to yellowish
- Lot/batch No.: 50546023
- Analytical purity: 95.1 %
- Storage condition of test material: cool, dry, dark

Method

Target gene:
histidine
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
not applicable
Species / strain / cell type:
S. typhimurium TA 102
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254 induced rat liver S9 homogenate
Test concentrations with justification for top dose:
with S9 mix: 1.5, 5, 15, 50, 150, 500, 1500 µg/plate
without S9 mix: 1.5, 5, 15, 50, 150, 500 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:
not specified
Positive controls:
yes
Remarks:
for TA98
Positive control substance:
2-nitrofluorene
Remarks:
without S9 homogenate

Migrated to IUCLID6: 2.5 µg/plate
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Remarks:
fot TA100, TA 1535
Positive control substance:
sodium azide
Remarks:
without S9 homogenate

Migrated to IUCLID6: 0.7 µg/plate
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Remarks:
for TA1537
Positive control substance:
9-aminoacridine
Remarks:
without S9 homogenate

Migrated to IUCLID6: 50 µg/plate
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Remarks:
for TA102
Positive control substance:
mitomycin C
Remarks:
wihout S9 homogenate

Migrated to IUCLID6: 0.15 µg/plate
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Remarks:
for TA98, TA100, TA102, TA1535
Positive control substance:
other: 2-aminoanthracene, 0.8 µg/plate
Remarks:
with S9 homogenate
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Remarks:
for TA1537
Positive control substance:
other: 2-aminoanthracene, 1.7 µg/plate
Remarks:
with S9 homogenate
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 48 - 72 h


DETERMINATION OF CYTOTOXICITY
- Method: reduction in the number of revertant colonies and/or a diminution of the background lawn

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
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 102
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Additional information on results:
TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: not observed

ADDITIONAL INFORMATION ON CYTOTOXICITY:
Cytotoxic concentrations:
Without S9:
150ug/plate for TA1537;
500 µg/plate for TA98, TA100, TA1535; TA102

With S9:
500 µg/plate for TA98, TA100, TA1535, TA102
1500 µg/plate - for TA1537
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion