Registration Dossier

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:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 / strainopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
Rat liver S9 mix
Species / strain:
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
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 resultsopen allclose all
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
yes
Remarks:
at the highest concentration (500 µg/plate)
Negative controls valid:
yes
Positive controls valid:
yes
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
yes
Remarks:
at the highest concentration (500 µg/plate)
Negative controls valid:
yes
Positive controls valid:
yes
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
yes
Remarks:
at the highest concentration (500 µg/plate)
Negative controls valid:
yes
Positive controls valid:
yes
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
yes
Remarks:
at the highest concentration (500 µg/plate)
Negative controls valid:
yes
Positive controls valid:
yes
Key result
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
yes
Remarks:
at the highest concentration (500 µg/plate)
Negative controls valid:
yes
Positive controls valid:
yes

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.