[No public or meaningful name is available]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14 December 2021 - 05 May 2022

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2022

Report date:

2022

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

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

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Cell source:

other: Adult donors

Vehicle:

unchanged (no vehicle)

Details on test system:

The reconstructed human epidermal model EpiDerm™ (EPl-200-MatTek Corporation) consists of normal human-derived epidermal keratinocytes which have been cultured to form a multi-layered highly differentiated model of the human epidermis. It consists of organised basal, spinous, and granular layers and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo.

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

30µL

Duration of treatment / exposure:

1 hour

Duration of post-treatment incubation (if applicable):

42 hours

Number of replicates:

3 of each, negative control, positive control, and test item

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

1 hour

Value:

9.549

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Interpretation of results:

other: Irritant to the skin

Conclusions:

The relative mean tissue viability obtained after a 1 hour treatment with the substance compared to the negative control tissues was 9.549%. Since the mean relative tissue viability for the substance was below 50%, the substance is considered to be irritant.

Executive summary:

In an in vitro skin corrosion human skin model test (EpiDerm) according to OECD guildeline 439 and in compliance with GLP, the mean relative tissue viability for the substance was below 50%, the substance is therefore considered to be irritant.