[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:

2020

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2020

Report date:

2020

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2019

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction products of 2,2'-(1,3-phenylenebis(oxy))diethanol with 2-(phenoxymethyl)oxirane and 2-isocyanatoethyl methacrylate

Cas Number:

1431303-59-1

Molecular formula:

Not assigned for UVCB substance.

IUPAC Name:

Reaction products of 2,2'-(1,3-phenylenebis(oxy))diethanol with 2-(phenoxymethyl)oxirane and 2-isocyanatoethyl methacrylate

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: 3M Company, no information
- Purity, including information on contaminants, isomers, etc.: No information

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability and homogeneity of the test material in the vehicle/solvent under test conditions (e.g. in the exposure medium) and during storage: Not determined
- Stability in the medium, i.e. sensitivity of the test material to hydrolysis and/or photolysis: Not determined
- Solubility and stability of the test material in the solvent/vehicle and the exposure medium: Not determined
- Reactivity of the test material with the incubation material used (e.g. plastic ware): Not determined

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing (e.g. warming, grinding): Heated to 70C
- Preliminary purification step (if any): No information

FORM AS APPLIED IN THE TEST (if different from that of starting material) : Liquid applied to test system after being heated to 70C

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Vehicle:

unchanged (no vehicle)

Details on test system:

RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: MatTek EpiDerm Reconstructed Human Epidermis (RhE). Epi-200 RhE Tissues
- Tissue batch number(s): Lot 33026 Kit J
- Production date: No data
- Shipping date: 28 April, 2020
- Delivery date: 28 April, 2020
- Date of initiation of testing: 29 April, 2020

TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 C
- Temperature of post-treatment incubation (if applicable): 37 C

REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: At the end of exposure, tissues were washed with a stream of DPBS which completely removed the control solutions but did not completely remove the test substance. Test group tissues maintained viability above the cutoff following the normal timing and steps of the test.
- Observable damage in the tissue due to washing: None.
- Modifications to validated SOP: None

MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL in DMEM
- Incubation time: 3 hours
- Spectrophotometer: Molecular Devices model i3
- Wavelength: 570 nm
- Filter: No data
- Filter bandwidth: No data
- Linear OD range of spectrophotometer: No data


NUMBER OF REPLICATE TISSUES: 3

CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE : NA

- N. of replicates :
- Method of calculation used:

NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1

PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be irritating to the skin if the mean relative tissue viability of three individual tissues exposed to the test substance is reduced to or below 50% of the mean viability of the negative controls.

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 uL
- Concentration (if solution): Dosed unchanged

NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 uL
- Concentration (if solution): Dosed unchanged

POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 uL
- Concentration (if solution): Dosed unchanged

Duration of treatment / exposure:

60 minutes

Duration of post-treatment incubation (if applicable):

42 hours

Number of replicates:

3

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

Mean

Value:

76

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Other effects / acceptance of results:

- OTHER EFFECTS:
- Visible damage on test system: Not observed
- Direct-MTT reduction: Not observed
- Colour interference with MTT: Not observed

ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes
- Acceptance criteria met for variability between replicate measurements: Yes
- Range of historical values if different from the ones specified in the test guideline: Contract research lab maintains records of historical control data for reference.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

ERGP-IEM is identified as a non-irritant material when tested according to OECD 439.

Executive summary:

ERGP-IEM was assessed for its skin irritation potential in a GLP-compliant, OECD Guideline 439 (2019) skin irritation test using the reconstructed human epidermal tissue model, EpiDerm. Tissues were exposed to 30uL of the test substance heated to 70C; the negative control, DPBS; the experimental control, DPBS heated to 70C; and the positive control, 5% Sodium Dodecyl Sulfate, in triplicate for 60 minutes, washed, and given a 42 -hour post exposure incubation. Viability was determined using the MTT assay. Viability is expressed as % of the negative control condition. The controls behaved as expected. Mean tissue viability of ERGP-IEM-exposed tissues was 76% compared to negative controls following a 60 minute exposure. Based on the results of the study, ERGP-IEM is identified as a non-irritant material when tested according to OECD 439.