2-Propenoic acid, 2-isocyanatoethyl ester

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

The experimental phase of the study was undertaken from 19 April to 20 April 2007.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study (OECD 431), performed under GLP conditions. Actual guideline not mentioned in report.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: OECD 431 (In Vitro Skin Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Date of inspection: 7th March 2005

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

482-140-6

EC Name:

-

Cas Number:

13641-96-8

Molecular formula:

Hill formula: C6 H7 N O3 CAS formula: C6 H7 N O3

IUPAC Name:

2-isocyanatoethyl prop-2-enoate

Test animals

Species:

human

Strain:

other: not applicable

Details on test animals or test system and environmental conditions:

Normal human-derived epidermal keratinocytes which had been cultured on 0.6 cm² inserts to form a multilayered stratum corneum.

Test system

Type of coverage:

other: not applicable, in vitro test system

Preparation of test site:

other: not applicable

Vehicle:

unchanged (no vehicle)

Controls:

other: negative control sodium chloride

Amount / concentration applied:

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

Duration of treatment / exposure:

3 minutes and 1 hour

Observation period:

Not applicable

Number of animals:

In duplicates

Details on study design:

TEST SITE
- Area of exposure: 0.6 cm² tissue inserts

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with Dulbeco's Phosphate Buffered Saline (DPBS)
- Time after start of exposure: 3 min and 1 hour, respectively

SCORING SYSTEM:
EPIDERM HUMAN SKIN MODEL:
Assessment of tissue viability after 3 min and 1 h exposure, respectively, determined by MTT assay.

If the tissue viability from the 3 minute exposure is less than 50% of the negative control value, then the sample is classified as corrosive. If the tissue viability from the 3 minute exposure is greater than or equal to 50% of the negative control value but the 1 hour value is less than 15% of the negative control value, the sample is classified as corrosive. If the mean tissue viability from the 3 minute exposure is greater than or equal to 50% and the 1 hour value is greater than or equal to 15% of the negative control value, then the sample is classified as non-corrosive.

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

other: other: mean tissue viability

Value:

43.4

Remarks on result:

other:

Remarks:

Basis: mean. Time point: 3 min. Reversibility: other: not applicable, in vitro test system. Remarks: Corrosive.

Results 2

Irritation / corrosion parameter:

other: other: mean tissue viability

Value:

26.5

Remarks on result:

other:

Remarks:

Basis: mean. Time point: 1 hour. Reversibility: other: not applicable, in vitro test system.

Other effects / acceptance of results:

When the Prediction Model is applied, the test material, AOI, with a mean tissue viability of 43.4% for 3 minute contact and 26.5 % for 1 hour contact, is predicted as corrosive.

Applicant's summary and conclusion

Interpretation of results:

other: Under the conditions of the conducted test, the test substance was corrosive towards reconstructed human epidermis tissue in the EpiDerm™ model.