Butanal, 3-methyl-, reaction products with 3-methyl-3-buten-1-ol, distn. lights

Genetic toxicity: in vitro

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:

1989-03-03 and 1989-03-09 (testing days)

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study without GLP, four strains only.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

3-methylbut-3-en-1-ol

EC Number:

212-110-8

EC Name:

3-methylbut-3-en-1-ol

Cas Number:

763-32-6

Molecular formula:

C5H10O

IUPAC Name:

3-methylbut-3-en-1-ol

Details on test material:

- Name of test material (as cited in study report): 3-Methylbuten-3-ol-1
- Analytical purity: 99%
- Lot/batch No.: 31-0342
- Storage condition of test material: at room temperature
No further data

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254-induced rat liver S-9

Test concentrations with justification for top dose:

20, 100, 500, 2500, 5000 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO

Controls

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene, N-methyl-N'-nitro-N-nitrosoguanidine, 4-nitro-o-phenylendiamine, 9-aminoacridine chloride monohydrate

Remarks:

positive control substance depending on tester strain and activation condition

Details on test system and experimental conditions:

Two independent experiments were carried out.

1st Experiment:
METHOD OF APPLICATION: in agar (plate incorporation)
Standard plate incorporation test with and without metabolic activation with S-9 mix prepared from liver homogenate of Aroclor 1254-pretreated Sprague-Dawley rats.
TEST CONCENTRATION: 0, 20, 100, 500, 2500 and 5000 µg/plate
SOLVENT: DMSO
NUMBER OF REPLICATIONS: 3 test plates per dose or per control
DETERMINATION OF CYTOTOXICITY
- Method: reduced his- background growth, decrease in the number of his+ revertants

2nd Experiment
METHOD OF APPLICATION: preincubation;
Preincubation test with and without metabolic activation with S-9 mix prepared from liver homogenate of Aroclor 1254-pretreated Sprague-Dawley rats.
TEST CONCENTRATION: 0, 20, 100, 500, 2500 and 5000 µg/plate
SOLVENT: DMSO
NUMBER OF REPLICATIONS: 3 test plates per dose or per control
DETERMINATION OF CYTOTOXICITY
- Method: reduced his- background growth, decrease in the number of his+ revertants

Evaluation criteria:

In general, a substance to be characterized as positive in the Ames 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 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

>= 2500 µg/plate

Vehicle controls validity:

valid

Positive controls validity:

valid

Additional information on results:

An increase in the number of his+ revertants was not observed both in the standard plate test and in the preincubation test either without S-9 mix or after the addition of a metabolizing system. Positive control experiments gave the expected increase in the number of revertants.

TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Complete solubility of the test substance in DMSO.

ADDITIONAL INFORMATION ON CYTOTOXICITY:
A bacteriotoxic effect was observed only in the preincubation test without S-9 mix using TA 1537 and TA 98 at doses >= 2500 µg/plate .

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

According to the results of the present study, the test substance 3-Methylbuten-3-ol-1 is not mutagenic in the Ames test under the experimental conditions chosen here.