[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:

March, 4 2021 to April 14, 2021

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2021

Report date:

2021

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

D‐Glucopyranose, oligomeric, C10‐16‐alkyl glycosides, 3‐(3,4‐dicarboxy‐3‐hydroxy‐1‐oxobutoxy)‐2‐hydroxypropyl ethers, sodium salts

Cas Number:

2481100-10-9

Molecular formula:

not applicable (UVCB substance)

IUPAC Name:

D‐Glucopyranose, oligomeric, C10‐16‐alkyl glycosides, 3‐(3,4‐dicarboxy‐3‐hydroxy‐1‐oxobutoxy)‐2‐hydroxypropyl ethers, sodium salts

Details on test material:

- Name of test material (as cited in study report): Suga®Citrate L1C
- Physical state: clear viscous liquid
- Purity: ca. 40% AS

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Metabolic activation:

with and without

Metabolic activation system:

S9 mix

Test concentrations with justification for top dose:

To set the dose levels for the main test, the dose-finding test was conducted with test article
treatment doses levels of19.5, 78.1, 313, 1250, and 5000 μglplate.
As a result, there was no increase in the number of revertant colonies, the minimum dose which
showed growth inhibition was selected as the maximum dose for the main test, and the main
test was conducted in the following dose levels. For all strains without metabolic activation, the
maximum dose was set at 78.1 μglplate, and diluted using a common ratio of 2 to prepare a
total of 6 dose levels. For all strains with metabolic activation, the maximum dose was set at
1250 μglplate, and diluted using a common ratio of 2 to prepare a total of 6 dose levels.

Vehicle / solvent:

Water

Controls

Negative solvent / vehicle controls:

yes

Remarks:

Water

Positive controls:

yes

Positive control substance:

sodium azide

benzo(a)pyrene

other: see remark

Results and discussion

Test results

Test results 1

Key result

Species / strain:

E. coli WP2 uvr A

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 1537

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 3

Key result

Species / strain:

S. typhimurium TA 98

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 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

Test results 5

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

Applicant's summary and conclusion

Conclusions:

The study is regarded as valid because there were no deviations from the test protocols, the study has been performed according to the principles of Good Laboratory Practice, and all validity criteria are fulfilled. Under the test conditions (both with and without metabolic activation) and with the bacterial strains used the test item is considered not to induce a mutagenic effect (induction of gene mutation).

Executive summary:

In order to examine the gene mutation inducibility of Disodium Laurylglucosides
Hydroxypropyl Citrate, a reverse mutation assay was conducted in Salmonella typhimurium
(hereinafter referred to as S typhimurium) TAlO0, TA1535, TA98 and TA1537, and
Escherichia coli (hereinafter referred to as E coli) WP2 uvr A with or without metabolic
activation by the pre-incubation method. Distilled water was used as the vehicle for the test
article.
To set the dose levels for the main test, the dose-finding test was conducted with test article
treatment doses levels of19.5, 78.1, 313, 1250, and 5000 μglplate.
As a result, there was no increase in the number of revertant colonies, the minimum dose which
showed growth inhibition was selected as the maximum dose for the main test, and the main
test was conducted in the following dose levels. For all strains without metabolic activation, the
maximum dose was set at 78.1 μglplate, and diluted using a common ratio of 2 to prepare a
total of 6 dose levels. For all strains with metabolic activation, the maximum dose was set at
1250 μglplate, and diluted using a common ratio of 2 to prepare a total of 6 dose levels. The
main test was conducted twice at the same dose levels.

In conclusion, the result of Disodium Laurylglucosides Hydroxypropyl Citrate was judged to
have no potential to induce gene mutations (negative) under the conditions of this study.