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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study according to current guideline, GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Qualifier:
according to guideline
Guideline:
OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrahydro-2-isobutyl-4-methyl-2H-pyran
EC Number:
236-770-1
EC Name:
Tetrahydro-2-isobutyl-4-methyl-2H-pyran
Cas Number:
13477-62-8
Molecular formula:
C10H20O
IUPAC Name:
4-methyl-2-(2-methylpropyl)oxane
Details on test material:
Name of the test substance used in the study report: Dihydrorosenoxid

Method

Target gene:
his and trp
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254 induced rat liver S-9 mix
Test concentrations with justification for top dose:
4 µg - 5000 µg/plate (Standard Plate Test = SPT)
1 µg - 2500 µg/plate (Preincubation Test = PIT)
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
no
Positive controls:
yes
Remarks:
+S9: 2-aminoanthracene; -S9: N-methyl-N'-nitro-.N-nitrosoguanidine, 4-nitro-o-phenylendiamine, 9-aminoacridine chloride monohydrate, N-ethyl-N'-nitro-N-nitrosoguanidin
Details on test system and experimental conditions:
Standard Plate Test and Preincubation Test
METHOD OF APPLICATION: in agar (SPT); preincubation (PIT)

DURATION
- Preincubation period: 20 min (PIT)
- Exposure duration: 48h

DETERMINATION OF CYTOTOXICITY
- Method: reduced background growth, decrease in the number of his+ or trp+ revertants
Evaluation criteria:
In general, a substance to be characterized as positive in the bacterial test has to fulfill the following requirements:
- doubling of the spontaneous mutation rate (control)
- dose-response relationship
- reproducibility of the results.

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Additional information on results:
TEST-SPECIFIC CONFOUNDING FACTORS
- Solubility: Complete solubility of the test substance in DMSO.

ADDITIONAL INFORMATION ON CYTOTOXICITY: A bacteriotoxic effect was observed using the Salmonella strains at doses > 100 µg/plate (PIT) or from about 2500 µg/plate onward (SPT) and with E. coli WP2 uvrA at doses > 500 µg/plate (PIT) or at 5000 µg/plate (SPT)
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion