[No public or meaningful name is available]

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)

Version / remarks:

No data

Deviations:

no

Remarks:

No deviations ocurred that negatively impacted the integrity of the study.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 1,10-decanediol dimethacrylate (CAS 6701-13-9) and 10-methacryloyl-oxy-decylphosphate

Molecular formula:

C18H30O4 and C14H27O6P

IUPAC Name:

Reaction mass of 1,10-decanediol dimethacrylate (CAS 6701-13-9) and 10-methacryloyl-oxy-decylphosphate

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,
- Purity, including information on contaminants, isomers, etc.: Reaction product as described in the general information section.

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At 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: NA
- Stability in the medium, i.e. sensitivity of the test material to hydrolysis and/or photolysis: No data
- Solubility and stability of the test material in the solvent/vehicle and the exposure medium: No data
- Reactivity of the test material with the incubation material used (e.g. plastic ware): No data

TREATMENT OF TEST MATERIAL PRIOR TO TESTING : None, dosed neat.

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

other: Three-dimensional human epidermis model - EpiDerm

Cell source:

other: No data

Details on animal used as source of test system:

SOURCE ANIMAL
- Source: Human
- Sex: No data
- Age at study initiation (in days): No data
- Weight at study initiation: No data
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data

Justification for test system used:

EpiDerm is recommended per OECD 431 guideline.

Vehicle:

unchanged (no vehicle)

Details on test system:

RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: MatTek EpiDerm
- Tissue batch number(s): 27170 Kit C
- Production date: No data
- Shipping date: No data
- Delivery date: 24 Oct 2017
- Date of initiation of testing: 25 Oct 2017

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: 2 washing steps, volume not reported.
- 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: 300 uL at 1 mg/mL MTT
- Incubation time: 3 hours
- Spectrophotometer: uQuant Plate Reader, Bio-Tek Instruments
- Wavelength: 540 nm
- Filter: No data
- Filter bandwidth: No data
- Linear OD range of spectrophotometer: No data

NUMBER OF REPLICATE TISSUES: 3 per group (test, negative control, positive control).

CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE : No data

NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1 experiment in triplicate.

PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is less than 50%, or if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15%.
- The test substance is considered to be non-corrosive to skin if the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%.

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 uL
- Concentration (if solution): Neat

VEHICLE : None

NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 uL
- Concentration (if solution): NA

POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 uL
- Concentration (if solution): 8.0 N

Duration of treatment / exposure:

3 and 60 minutes

Duration of post-treatment incubation (if applicable):

3 hour incubation with MTT post-exposure

Number of replicates:

3

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

3 Minute Exposure Mean

Value:

80.6

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Results 2

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

60 Minute Exposure Mean

Value:

4.7

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Other effects / acceptance of results:

- OTHER EFFECTS:
- Visible damage on test system: None
- Direct-MTT reduction: None
- Colour interference with MTT: None

DEMONSTRATION OF TECHNICAL PROFICIENCY: The laboratory has demonstrated proficiency in running OECD 431 with EpiDerm tissues.

ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes, the mean OD of the negative control tissues was 2.246 at 3 minutes and 2.092 at 60 minutes, which met the acceptance criterion (OD greater than or equal to 0.8).
- Acceptance criteria met for positive control: Yes, the mean relative tissue viability of the 60-minute positive control was 2.4%, which met the acceptance criterion (>15%).
- Acceptance criteria met for variability between replicate measurements: Yes, viability differences between the two identically treated tissues in all samples and controls at 3 minutes were 2.9% to 7.7%. Viability differences between the two identically treated tissues at 60 minutes were 0.1 % to 1.3%. Inter-tissue viability differences at both time points met the acceptance criterion (>30%)
- Range of historical values if different from the ones specified in the test guideline: Per OECD 431.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (corrosive) based on GHS criteria

Conclusions:

Based on the results of the study (3 minute viability 4.7%, 60 minute viability 80.6%), MDP is corrosive when tested according to OECD 431 with EpiDerm tissues.

Executive summary:

The skin corrosion potential of MDP was evaluated in MatTek EpiDerm tissues. The study was conducted according to OECD 431 in compliance with OECD GLP. EpiDerm tissues were exposed (N=3) to 50 uL of the test article (MDP), negative control (tissue culture water), and positive control (potassium hydroxide, 8.0 N) for 3 and 60 minutes. Following exposure the tissues were washed and incubated with MTT to determine tissue viability. Relative viability was 80.6% after a 3 minute exposure and 4.7% after a 60 minute exposure. Based on the results of the study (3 minute viability 4.7%, 60 minute viability 80.6%), MDP is corrosive when tested according to OECD 431 with EpiDerm tissues.