1-diethylaminopropan-2-ol

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

1-diethylaminopropan-2-ol

EC Number:

224-537-7

EC Name:

1-diethylaminopropan-2-ol

Cas Number:

4402-32-8

Molecular formula:

C7H17NO

IUPAC Name:

1-(diethylamino)propan-2-ol

Test material form:

liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source; lot No. of test material: Nisshinbo Chemical Inc.; 7B01AA
- Purity test date: >= 99%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: The test item was put into an airtight container shielded from light and stored at room temperature in the test item storage room (permissible range: from 10°C to 30°C).
- Stability under test conditions: Stable
- Solubility and stability of the test substance in the solvent/vehicle: The test item was soluble in distilled water at 50.0 mg/mL. The test item solution of 50.0 mg/mL prepared with distilled water was considered to be stable from the facts that there were no changes in color, exothermic reaction nor gas generation at room temperature within 4 hours after preparation (confirmed at the testing facility).
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: no reactivity

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test item was weighted, added into distilled water and mixed with a laboratory mixer to make a 50.0 mg/mL of original solution. The test item solutions of each required concentration were prepared with the same vehicle. The test item solutions were prepared just before use, kept under yellow light at room temperature and used within 4 hours after preparation.

Method

Target gene:

His

Species / strain

Species / strain 1

Species / strain / cell type:

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

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A

Metabolic activation:

with and without

Metabolic activation system:

Rat liver S9 mix

Test concentrations with justification for top dose:

5000, 2500, 1250, 625, 313 and 156 µg/plate

Controls

Untreated negative controls:

yes

Positive controls:

yes

Positive control substance:

sodium azide

other: 2-(2-Furyl)-3-( 5-nitro-2-furyl)acrylarnide; 2-Aminoanthracene; ICR-191

Results and discussion

Test results

Test results 1

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at the highest concentration (500 µg/plate)

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Key result

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at the highest concentration (500 µg/plate)

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 3

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at the highest concentration (500 µg/plate)

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 4

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at the highest concentration (500 µg/plate)

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 5

Key result

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at the highest concentration (500 µg/plate)

Untreated negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

lt was concluded that 1-diethylaminopropan-2-ol had no ability to induce mutations under the present test conditions.

Executive summary:

The mutagenicity of the test item was judged to be negative because the number of revertant colonies in the test item treatment groups was less than twice that in the negative control for all tester strains regardless ofthe presence or absence of S9 mix.

The numbers of revertant colonies in the positive controls were above twice that in the negative controls. The test results showed that the numbers of revertant colonies in the negative and positive controls were within the range of the historical data at the testing facility. lt was also confirmed that the test system was free from bacterial contamination, which declares the test results to be valid.