Reaction product of 2-hydroxyethylacrylate with imidazole

Eye irritation

Administrative data

Endpoint:

eye 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

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)

Version / remarks:

28 July 2015

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

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

50ml

Duration of treatment / exposure:

30min

Duration of post- treatment incubation (in vitro):

2h

Number of animals or in vitro replicates:

2

Results and discussion

In vitro

Results

Irritation parameter:

other: Tissue Viability (%)

Value:

81.8

Vehicle controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

The supplier demonstrates that each batch of the model used meets the defined production release criteria. MatTek determines the ET50 (min) value following exposure to 100 μL of 0.3% Triton X-100 for each EpiOcular™ EIT (OCL-200) batch. The ET50 must fall within a range established based on a historical database of results. The following acceptability range (upper and lower limit) for the ET50 is established by the supplier as described in the cited OECD Guideline.
Lower acceptance limit: ET50 = 12.2 min
Upper acceptance limit: ET50 = 37.5 min

Acceptance criteria for the NC:
The absolute OD570 of the NC-tissues in the MTT-test is an indicator of tissue viability obtained in the testing laboratory after the shipping and storing procedure and under specific conditions of the assay. Tissue viability is acceptable if the mean OD570 of the NC is > 0.8. The mean OD570 of the NC should not exceed 2.5.

Acceptance criteria for the PC:
Methyl acetate used as PC usually leads to a tissue viability of approx. 25%. A viability of < 50% is acceptable.

Acceptance criteria for tissue variability:
A variability between the two tissues is considered to be acceptable if the relative difference of the viability is < 20%.

Evaluation of results:
Viability < 55% => irritang
Viability > 55 < 65 % => Borderline, a second test is considered
Viability > 65 % => non-irritant

In vivo

Other effects:

The test substance does not directly reduce MTT.

Any other information on results incl. tables

Since the substance was evaluated as non-irritant in the Epiocular, it was unnecessare to perform a BCOP to distinguish between irritant and corrosive effects.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met