1,2-Benzenediol, 4-(2-hydroxyethyl)-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 31st 2021 to June 6th 2021

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2021

Report date:

2021

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test material

Test material information

1

Reference substance name:

4-(2-hydroxyethyl)benzene-1,2-diol

EC Number:

600-704-3

Cas Number:

10597-60-1

Molecular formula:

C8H10O3

IUPAC Name:

4-(2-hydroxyethyl)benzene-1,2-diol

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: NM20180815
- Purity, including information on contaminants, isomers, etc.: 100%


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

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Cell source:

foreskin from a single donor

Vehicle:

water

Remarks:

distilled water

Details on test system:

The treatments (NC/PC/sample/s) were carried out under sterile conditions. After exposure the
tissues were washed with 1x PBS and incubated for 42 hours at 37ºC temperature, 5% CO2 and
95% relative humidity.
The cell viability (CV, “Cell Viability”) was determined by MTT assay, expressed as an average in
percentage with respect to the average of the negative control.
Optical densities of the negative control (medium) were in all cases equal or higher than 0.8
and equal or lower than 3.0

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

2 and 100%

Duration of treatment / exposure:

The tissues were exposed with controls and the sample/s in triplicate, at a concentration of
100% for 42 minutes at RT

Number of replicates:

Triplicate

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

3

Value:

ca. 10.2

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Results 2

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

2

Value:

ca. 10

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Results 3

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

1

Value:

ca. 10.07

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Any other information on results incl. tables

Cell viability of the positive control (SDS 5%) was lower than 40%.

The standard deviations were less than 18% for both controls and samples. Exceptionally, some data was discarded to meet this last criterion.

n the interaction tissues, the sample is considered to have no interaction with the TBT because the value of the negative control is higher than the value of the sample. In addition, the value of the sample interaction tissues and the value of the assay tissues is very similar, therefore it is reconfirmed that there is no interaction with TBT.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

The classification of the sample (s) al 100% taking into account the reference protocol scheme
("OECD 439") is Category 2 Irritant
Optical densities of the negative control (medium) were in all cases equal or higher than 0.8
and equal or lower than 3.0.