[No public or meaningful name is available]

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October 16, 2018 to May 31, 2019

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2019

Report date:

2019

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: GB/T 21786-2008: Chemical-Test method of bacterial reverse mutation

GLP compliance:

no

Remarks:

According GLP but not certified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Sulfonic acids, C16-alkane hydroxy and C16-alkene, potassium salts

Cas Number:

2210238-42-7

IUPAC Name:

Sulfonic acids, C16-alkane hydroxy and C16-alkene, potassium salts

Test material form:

cream / paste

Remarks:

Pale yellow paste under 50℃. This sample was obtained from the original liquid form by removing water.

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 97a

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 98

Species / strain 3

Species / strain / cell type:

S. typhimurium TA 100

Species / strain 4

Species / strain / cell type:

S. typhimurium TA 102

Species / strain 5

Species / strain / cell type:

S. typhimurium TA 1535

Metabolic activation:

with and without

Metabolic activation system:

S9 mix

Test concentrations with justification for top dose:

The test is performed both in existence and absence of the S9mix by adopting plate incorporation method. The growth inhibition of test strains was observed in the preliminary experiment when the dose was 800µg/plate. According to the results of preliminary experiment, five dose groups were used in the test including (50 µg/plate, 100 µg/plate, 200 µg/plate, 400 µg/plate and 800 µg/plate), as well as spontaneous control, solvent control (distilled water) and the positive control.

Vehicle / solvent:

Distilled water

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

2-acetylaminofluorene

sodium azide

other: Dexon, 1,8-dihydroxy anthraquinone

Details on test system and experimental conditions:

Method of application: Plate incorporation method.
Exposure duration: 48 h
Temperature: 37℃

Evaluation criteria:

The test must be repeated once, and the result is expressed by mean value. If the number of revertant colonies of test group is over twice than that of the spontaneous revertant colonies and shows a dose-response relationship, the result is positive.

Results and discussion

Test results

Test results 1

Key result

Species / strain:

S. typhimurium TA 97a

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 3

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 4

Key result

Species / strain:

S. typhimurium TA 102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 5

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

According to the evaluation criteria about Ames test of the GB/T21786-2008 Chemical-Test method of bacterial reverse mutation, the result of the Ames test of C16K is negative.

Executive summary:

As show in Table 1 and Table 2, under the conditions with or without S9mix metabolic activation system, compared with that of spontaneous revertant colonies, the number of revertant colonies for each dose group in the two main tests of different concentration range did not exceed twice, and showed no dose-response relationship.