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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
Study period:
11 April 2012 - 16 May 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
Deviations:
no
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

1
Chemical structure
Reference substance name:
1-butoxy-3-(prop-2-en-1-yloxy)propan-2-ol
EC Number:
801-709-5
Cas Number:
53146-45-5
Molecular formula:
C10H20O3
IUPAC Name:
1-butoxy-3-(prop-2-en-1-yloxy)propan-2-ol
Specific details on test material used for the study:
Appearance: Liquid (specific gravity: 0.95)
Batch: AB20
Purity: 92%
Storage Conditions: Room temperature in the dark

Method

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:
E. coli WP2 uvr A
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
S9 Mix
Test concentrations with justification for top dose:
Preliminary test (dose range finder): 0 (solvent control), 1.2, 4.9, 20, 78, 313, 1250, 5000 µg/plate
Main test: 0 (solvent control), 156, 313, 625, 1250, 2500, 5000 µg/plate.
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Based on information from the sponsor it was noted that the test material was insoluble in water. A solubility test was conducted in DMSO (50 mL) and Acetone (100 mL). The test material was soluble in each solvent and neither solution gave signs of reaction (evolution of gas or an exothermic reaction). DMSO was therefore selected as the solvent.
Controlsopen allclose all
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
other: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide
Remarks:
Used for TA100, TA98, and WP2 uvrA in the absence of S9 mix
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
Used for TA1535 in the absence of S9 mix
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
other: 2-Methoxy-6-chloro-9-[3-(2-chloroethyl)aminopropylamino]acridine.2HCl
Remarks:
Used for TA1537 in the absence of S9 mix
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
benzo(a)pyrene
Remarks:
Used for TA100, TA98, and TA1537 in the presence of S9 mix
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
other: 2-Aminoanthracene
Remarks:
Used for TA1535 and WP2 uvrA in the presence of S9 mix
Details on test system and experimental conditions:
METHOD OF APPLICATION:in agar (plate incorporation)

DURATION
- Preincubation period: 20 minutes
- Exposure duration: 48 hours

NUMBER OF REPLICATIONS: Two plates for each dose level

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth
Evaluation criteria:
The number of revertant colonies were counted and compared with the number of colonies on the control plates. A significant increase in the number was judged as a two-fold increase in the number of colonies relative to the negative control, and a dose-response with reproducibility was considered to indicate a positive result.

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:
Growth inhibition was observed at the highest test concentrations
Vehicle controls validity:
valid
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:
Growth inhibition was observed at the highest test concentrations
Vehicle controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
From the results described above, it is concluded that the test item is not mutagenic in the bacterial reverse mutation assay carried out under the experimental conditions.

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