Lithium iodide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21 october 2021 to 29 october 2021

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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 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:

Lithium iodide

EC Number:

233-822-5

EC Name:

Lithium iodide

Cas Number:

10377-51-2

Molecular formula:

ILi

IUPAC Name:

lithium iodide

Test material form:

solid

Specific details on test material used for the study:

Batch no. 1210621A-0915P

In vitro test system

Test system:

human skin model

Remarks:

The test system is a commercially available EpiDermTM-Kit, procured by MatTek. The EpiDermTM tissue consists of human-derived epidermal keratinocytes which have been cultured to form a multi-layered, highly differentiated model of the human epidermis.

Source species:

human

Cell type:

non-transformed keratinocytes

Cell source:

other: EpiDermTM-Kit, procured by MatTek.

Source strain:

other: EpiDermTM: EPI-212-SIT

Vehicle:

unchanged (no vehicle)

Details on test system:

SPECIFICATION
The test system is a commercially available EpiDermTM-Kit, procured by MatTek.
The EpiDermTM tissue consists of human-derived epidermal keratinocytes which have been cultured to form a multi-layered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers representing main
lipid classes analogous to those found in vivo. The EpiDermTM tissues are cultured on specially prepared cell culture inserts.

ORIGIN:
EpiDermTM tissues were procured from MatTek In Vitro Life Science Laboratories, Bratislava.
Designation of the kit: EPI-212-SIT
Day of delivery: 26. Oct. 2021
Batch no.: 36101

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Duration of treatment / exposure:

60 minutes

Test system

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

yes

Duration of treatment / exposure:

The validity of the skin irritation study at LAUS GmbH was demonstrated in a non-GLP proficiency study. For this purpose, 10 proficiency chemicals (indicated by the OECD 439 guideline) were tested. All of the 10 proficiency chemicals were correctly categorized (see chapter 15). Therefore, the proficiency of the skin irritation study was demonstrated. 

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

run 1

Value:

ca. 7.9

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Remarks:

One valid experiment was performed. Three tissues of the human skin model EpiDermTM were treated with the test item for 60 minutes. After the treatment with the test item, the mean value of relative tissue viability was reduced to 7.9%. This value is below the threshold for skin irritation potential (50%). Test items that induce values below the threshold of 50% are considered at least irritant to skin. The optical density of the negative control was well within the required acceptability criterion of 0.8 ≤ mean OD ≤ 2.8. The positive control has met the acceptance criterion too, for thus ensuring the validity of the test sys-tem. For these reasons, the result of the test is considered valid.

Conclusions:

After the treatment with the test item, the mean value of relative tissue viability was reduced to 7.9%. This value is below the threshold for skin irritation potential (50%). Test items that induce values below the threshold of 50% are considered at least irritant to skin.