2,3-dibromo-2-butene-1,4-diol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2018-05-14 - 2018-06-18

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 491 (Short Time Exposure In Vitro Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Phenylsuccinic acid

EC Number:

211-238-1

EC Name:

Phenylsuccinic acid

Cas Number:

635-51-8

Molecular formula:

C10H10O4

IUPAC Name:

2-phenylbutanedioic acid

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

Molecular Formula:
HOCH2C(Br)CH2OH
Molecular Weight:
245.91
Characteristics (Physical Appearance):
White crystalline powder
CAS No.:
3234-02-4
Batch Number:
1088
Purity:
100%

Test animals / tissue source

Species:

rabbit

Details on test animals or tissues and environmental conditions:

Cell line:
SIRC (Statens Seruminstitut Rabbit Cornea) cell line.
Medium:
Minimum essential medium (MEM) supplemented with
L-glutamine containing 10% fetal bovine serum (FBS) and Penicillin Streptomycin Solution (1X).
Culture Conditions:
37 ± 1 °C, ~5% CO2, 90 to 100% Humidity.
Cell refreshing Agent:
Dulbecco’ Phosphate Buffer Saline.
Cell Dispersion Agent:
0.25% Trypsin EDTA.

Test system

Vehicle:

other: mineral oil

Controls:

yes, concurrent vehicle

yes, concurrent positive control

Amount / concentration applied:

Test item was suspended uniformly in the mineral oil at 5% (w/w) concentration and further diluted by serial 10-fold dilution to 0.5% then to 0.05% concentration. Test item was tested at both 5% and 0.05% concentrations. Cells cultured in the 96-well plate were exposed to 200 μL/well of either a 5% or a 0.05% concentration of the test item suspension, for five minutes at room temperature.

Duration of treatment / exposure:

5 minutes

Number of animals or in vitro replicates:

9

Results and discussion

In vitro

Results

Results 1

Irritation parameter:

other: cell viability

Run / experiment:

5 %

Value:

22.32

Vehicle controls validity:

valid

Positive controls validity:

valid

Results 2

Irritation parameter:

other: cell viability

Run / experiment:

0.05%

Value:

100.17

Vehicle controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Interpretation of results:

other: No prediction can be made

Conclusions:

'Short Time Exposure In-Vitro Study Using SIRC Cell Line for Identification of Eye Irritation or Serious Eye Damage of Trans-2,3-Dibromo-2-Butene-1,4-Diol' was carried out in compliance with the Organization for Economic Co-operation and Development (OECD) Guidelines for Testing of Chemicals, Section 4, No. 491 - Short Time Exposure In Vitro Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage, adopted by the council on 09 October 2017 and as per mutually agreed Study Plan.
Under the given experimental conditions of 'Short Time Exposure In-Vitro Study Using SIRC Cell Line for Identification of Eye Irritation or Serious Eye Damage of Trans-2,3-Dibromo-2-Butene-1,4-Diol' (OECD Guideline No. 491)', it is concluded that this test method has successfully classified the test item into ‘No prediction can be made’ category as per the United Nations (UN) Globally Harmonised System (GHS) for classification of chemicals.

Executive summary:

'Short Time Exposure In-Vitro Study Using SIRC Cell Line for Identification of Eye Irritation or Serious Eye Damage of Trans-2,3-Dibromo-2-Butene-1,4-Diol' was carried out in compliance with the Organization for Economic Co-operation and Development (OECD) Guidelines for Testing of Chemicals, Section 4, No. 491 - Short Time Exposure In Vitro Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage, adopted by the council on 09 October 2017 and as per mutually agreed Study Plan.

Under the given experimental conditions of 'Short Time Exposure In-Vitro Study Using SIRC Cell Line for Identification of Eye Irritation or Serious Eye Damage of Trans-2,3-Dibromo-2-Butene-1,4-Diol' (OECD Guideline No. 491)', it is concluded that this test method has successfully classified the test item into ‘No prediction can be made’ category as per the United Nations (UN) Globally Harmonised System (GHS) for classification of chemicals.