1H-Imidazolium, 3-ethyl-1-methyl-, 1,1,1-trifluoromethanesulfonate (1:1)

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:

other: GLP and guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

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 Ocular Corrosives and Severe Irritants)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Commission Regulation (EU) 1152/2010

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-ethyl-3-methyl-1H-imidazol-3-ium trifluoromethanesulfonate

EC Number:

680-002-1

Cas Number:

145022-44-2

Molecular formula:

C6 H11 N2. C F3 O3 S

IUPAC Name:

1-ethyl-3-methyl-1H-imidazol-3-ium trifluoromethanesulfonate

Details on test material:

- Name of the test substance used in the study report: EMIM Triflat
- Test-substance No.: 09/0070-2
- Lot/batch No.: Los-Nr. 0000000001
- pH-value: ca. 5 (undiluted test substance)
- Physical state: Liquid
- Analytical purity: The test substance has been characterized by analyses
- Storage stability: The stability under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this
responsibility

Test animals / tissue source

Species:

other: isolated bovine cornea

Strain:

other: in vitro testing

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: each treatment group consisted of 3 corneas

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750µl
Negative Control (NC)
- De-ionized water
Positive Control (PC)
- Sodium hydroxide 1% (w/v) solution in de-ionized water

Duration of treatment / exposure:

10 minutes

Observation period (in vivo):

Post-exposure incubation: 2-hours

Details on study design:

The objective was to assess the potential of the test substance to cause serious damage to isolated bovine corneas for product safety and regulatory purposes. The assessment of serious eye damage is included in international regulatory requirements for the testing of chemicals. Due to animal welfare reasons serious eye damage was determined using the isolated corneas from the eyes of freshly slaughtered cattle.
After application of the test material to the epithelial surface of the corneas, corneal opacity is measured quantitatively as the amount of light transmission through the cornea. Permeability is measured quantitatively as the amount of sodium fluorescein dye that passes across the full thickness of the cornea. Both measurements are used to calculate an In Vitro Irritancy Score (IVIS) of the test substance, which is used for prediction of serious eye damage.
Corneal opacity was measured quantitatively as the amount of light transmission through the cornea. Permeability was measured quantitatively as the amount of sodium fluorescein dye that passes across the full thickness of the cornea. Both measurements were used to calculate an In Vitro Irritancy Score of the test substance relative to the control corneas.

Results and discussion

Any other information on results incl. tables

The following rules of assessment apply:

IVIS	Prediction
>55	risk of serious damage to the eyes
<= 55	no risk of serious damage to the eyes

Applicant's summary and conclusion

Conclusions:

Based on the observed results it was concluded, that EMIM Triflat does not cause serious eye damage in the Bovine Corneal Opacity and Permeability Test (BCOP Test) under the test conditions chosen.

Executive summary:

The potential of EMIM Triflat to cause serious damage to the eyes was assessed by a single topical application of 750 μL of the undiluted test substance to the epithelial surface of isolated bovine corneas. Three corneas were treated with the test substance for 10 minutes followed by a 2-hours post-incubation period. Corneal opacity was measured quantitatively as the amount of light transmission through the cornea. Permeability was measured quantitatively as the amount of sodium fluorescein dye that passes across the full thickness of the cornea. Both measurements were used to calculate an In Vitro Irritancy Score of the test substance relative to the control corneas. Based on the observed results it was concluded, that EMIM Triflat does not cause serious eye damage in the Bovine Corneal Opacity and Permeability Test (BCOP Test) under the test conditions chosen.