Reaction product of 2-hydroxyethylacrylate with imidazole

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted July 28th, 2015

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction product of 2-hydroxyethylacrylate with imidazole

EC Number:

926-135-3

Cas Number:

1181222-25-2

Molecular formula:

not applicable

IUPAC Name:

Reaction product of 2-hydroxyethylacrylate with imidazole

Test material form:

liquid: viscous

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 0015609877
- Purity test date: Oct 27, 2016 - Feb. 1, 2017
- pH: ca. 5

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature

In vitro test system

Test system:

human skin model

Remarks:

EpiDerm EPI-200

Source species:

human

Cell type:

non-transformed keratinocytes

Vehicle:

unchanged (no vehicle)

Details on test system:

RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPI-200
- Tissue batch number(s): 23385

TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperatur for 25 min, 37°C at 37°C
- Temperature of post-treatment incubation (if applicable): 37°C

MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1mg/ml
- Incubation time: 3h
- Spectrophotometer: Sunreise Absorbance Reader
- Wavelength: 570 nm

FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: 1.4 (acceptance range: 1 - 3)
- Barrier function: 6.44h (acceptance range 4.77 - 8.72h)
- Contamination: sterile

CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- not needed

PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be irritant to skin if the viability after 1 hour exposure is less than 45%
- The test substance is considered to be non-irritant to skin if the viability after 1 hour exposure is greater than 55%
- Intermediate results have to be clarified

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30µl

NEGATIVE CONTROL
- PBS

POSITIVE CONTROL
- sodium dodecyl sulfate (SDS) in water
- Concentration (if solution): 5%

A nylon mesh was placed carefully onto the tissue surface of the NC and PC afterwards.

Duration of treatment / exposure:

1h

Duration of post-treatment incubation (if applicable):

42 h (+/- 4h)

Number of replicates:

3

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Value:

90.1

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Remarks:

no further test for corrosion was performed

Other effects / acceptance of results:

The substance was considered not irritant to the skin. Consequently, no additional testing to distinguish between irritation and corrosion was required (e.g. according to OECD 431)

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met