3-chloro-2-[3-(chloroacetyl)-4,5-dihydro-1,2-oxazol-5-yl]phenyl methanesulfonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10 - 24 Aug 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)

Version / remarks:

adopted in 2013

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)

Version / remarks:

adopted in 2017

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)

Version / remarks:

adopted in 2010

GLP compliance:

yes (incl. QA statement)

Remarks:

Behörde für Gesundheit und Verbraucherschutz, Hamburg, Germany

Test material

Test material information

Constituent 1

Reference substance name:

3-chloro-2-[3-(2-chloroacetyl)-4,5-dihydro-1,2-oxazol-5-yl]phenyl methanesulfonate

EC Number:

811-477-7

Cas Number:

1446134-16-2

Molecular formula:

C12H11Cl2NO5S

IUPAC Name:

3-chloro-2-[3-(2-chloroacetyl)-4,5-dihydro-1,2-oxazol-5-yl]phenyl methanesulfonate

Test animals / tissue source

Species:

cattle

Strain:

not specified

Test system

Vehicle:

physiological saline

Controls:

yes, concurrent vehicle

yes, concurrent positive control

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 750 μL
- Concentration: 20% in physiological saline

VEHICLE CONTROL
- Amount applied: 750 µL
- Concentration: 0.9% (v/w)

POSITIVE CONTROL
- Amount applied: 750 µL
- Concentration: 20% in physiological saline

Duration of treatment / exposure:

4 h

Observation period (in vivo):

not applicable

Duration of post- treatment incubation (in vitro):

not applicable

Number of animals or in vitro replicates:

Three corneae were used for each treatment group.

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Remarks:

mean value of 3 corneae

Run / experiment:

4 h exposure

Value:

1.171

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.

Conclusions:

The irritation potential of the test substance was assessed in the BCOP assay. Application of the test substance to bovine corneae resulted in a calculated mean IVIS of 1.171 ± 1.444, which is below the cut-off value of 3 (UN GHS no category). Hence, the test item did not show severely irritant or corrosive properties. All validity criteria were within acceptable limits. Thus, the test substance is considered to be non-corrosive, but no prediction on the irritation potential can be made and further evaluation and/or data generation is required.