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

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 31st 2021 to June 11th 2021

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)

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:

Off white to light yellow powder
Stability 5 years
Expiration date 15/08/23
Batch NM20180815

Test animals / tissue source

Species:

other: reconstructed epithelium by airlifted culture of transformed human corneal keratinocytes

Details on test animals or tissues and environmental conditions:

- Cell line used, its source, passage number and confluence of cells used for testing: Epithelium consisting of viable layers of cells including columnar basal cells, transitional wing cells and superficial squamous cells
- RhCE tissue or hCE cell construct used, including batch number: EPIskin Batch 21-HCE-038
- For hCE cell: passage number and confluence of cells used, time and date of sub-culturing, duration of tripsinization, dilution ratio: Number of cell layers (5.5 cell layers)

Test system

Vehicle:

water

Remarks:

distilled water

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

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

VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required): NM20180815
- Purity: 100%

Duration of treatment / exposure:

The HCE tissues were exposed to controls and sample/s in duplicate, for 30 minutes (liquids) or for 4 hours (solids) at 37ºC.

Duration of post- treatment incubation (in vitro):

After treatment, a post-exposure immersion is carried out in fresh medium for 30 minutes at 37ºC (liquids) or at room temperature (solids), to remove any remaining sample absorbed in
the tissue. Furthermore, in the case of solid samples, an 18-hour post-immersion incubation
step is carried out at 37ºC

Number of animals or in vitro replicates:

Duplicate

Results and discussion

In vitro

Results

Irritation parameter:

mean percent tissue viability 

Value:

ca.

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The value of the tissues treated with the sample for the interaction test presents a lower value than
the interaction control tissues, so it is considered that the sample has no interaction with MTT.
In addition, the value of the tissues treated with the sample for the interaction test and the value of the tissues treated with the test sample is very similar, therefore it is confirmed that there is no
interaction with MTT.

Executive summary:

The classification of the sample tested at 2% is "No Category". If there are no statistically significant differences between sample and Negative Control, it is considered that the sample acts the same as the Control of the test and it can be clasify as "Non-irritant"