Registration Dossier

Diss Factsheets

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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Version / remarks:
adopted July 28th, 2015
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

Constituent 1
Chemical structure
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

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