bis(trifluoromethylsulfonyl)azanide;1-ethyl-3-methylimidazol-3-ium

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Study Initiation: January 18, 2018 Experiment Start Date: January 23, 2018 Experiment Termination Date: January 25, 2018 Study Termination (Draft Report): February 20, 2018

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 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:

OECD Guideline for testing of chemicals: Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage OECD 492, last version from 9 October 2017

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

1-ethyl-3-methyl-1H-imidazol-3-ium; trifluoro[(trifluoromethanesulfonylazanidyl)sulfonyl]methane

EC Number:

700-235-5

Cas Number:

174899-82-2

Molecular formula:

C8H11F6N3O4S2

IUPAC Name:

1-ethyl-3-methyl-1H-imidazol-3-ium; trifluoro[(trifluoromethanesulfonylazanidyl)sulfonyl]methane

Test material form:

liquid

Details on test material:

clear liquid, colorless

Specific details on test material used for the study:

Test Item Name 1-Ethyl-3-methylimidazolium bis(trifluoromethylsulfonyl)imide
Synonym EMIM-TFSI; EMIM-NTf2
Molecular weight 391.31 g/mol
Molecular Formula C8H11F6N3O4S2
CAS No 174899-82-2
EC-No 700-235-5
Lot No. 25PI208_12
Appearence colourless clear liquid
Purity > 99 %w
Homogenity homogenous
Production Date 27/04/2017
Expiry Date 05/2019

Storage Conditions: at 20±5°C, kept away from humidity

Test animals / tissue source

Species:

human

Details on test animals or tissues and environmental conditions:

The EpiOcular™ human cell construct for eye irritation testing (OCL-200-EIT) (Lot No. 27020) was obtained from MatTek In Vitro Life Science Laboratories, SR.

Standard Assay Kit Components (OCL-200-EIT)
1 Sealed 24-well plate (EPI-200) Contains 24 tissues in cell culture inserts on agarose
2 24-well plates sterile (Falcon) Used for MTT viability assay
6 6-well plates sterile (Falcon) Used for maintaining tissues during assay
1 bottle, 200 mL Assay medium (OCL-200-ASY) DMEM based medium
1 bottle, 100 mL DPBS Rinse Solution (TC-PBS) Used for wetting and rinsing the inserts

Test system

Controls:

yes, concurrent positive control

yes, concurrent negative control

Duration of treatment / exposure:

30- min exposure

Duration of post- treatment incubation (in vitro):

2-hour post-incubation after exposure

Number of animals or in vitro replicates:

Two tissue replicates

Results and discussion

In vitro

Results

Irritation parameter:

other: relative tissue viability

Remarks:

determined by the MTT reduction assay

Value:

101.4

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Any other information on results incl. tables

Eye irritation potentialof1-Ethyl-3-methylimidazolium bis(trifluoromethylsulfonyl)imideafter 30-min exposure in human model EpiOcular^TM

 

Test item	OD	SD	Viability	SD	in vivo
	mean	of OD	mean (%)	of viabilities	prediction
Negative control^a	1.940	0.008	100.0	0.44	NI
Positive control^b	0.904	0.021	46.6	1.11	I
1-Ethyl-3-methylimidazolium bis(trifluoromethylsulfonyl)imide	1.966	0.047	101.4	2.42	NI

a  H₂O

b  methyl acetate

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item 1-Ethyl-3-methylimidazolium bis(trifluoromethylsulfonyl)imide was examined for in vitro eye irritation in human model EpiOcularTM. The magnitude of viability was quantified by using MTT test.

Validity of the test method was ascertained by positive control methyl acetate. Two tissue replicates were used for each treatment (exposure time 30 minutes), including negative and positive controls.
The tissue viability met the acceptance criterion (mean OD of negative control was 1.940). The viability of culture treated by positive control methyl acetate was 46.6%. The positive control met the acceptance criterion: mean tissue viability less than 50%.

Determined viability of culture treated by 1-Ethyl-3-methylimidazolium bis (trifluoromethylsulfonyl)imide (101.4%) fulfilled the criteria for irritancy.
Therefore, the test item 1-Ethyl-3-methylimidazolium bis(trifluoromethylsulfonyl)imide is considered to be non irritant to the eye.

Executive summary:

The test item 1-Ethyl-3-methylimidazolium bis(trifluoromethylsulfonyl)imide was examined for eye irritation potential in EpiOcular^TMEye Irritation Test (OCL-200-EIT). 

The irritation potential of the test item was assessed in compliance with: OECD Guideline for testing of chemicals: Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals not Requiring Classification and Labelling for Eye Irritation or Serious EyeDamage OECD 492

and

Protocol: EpiOcular™ Eye Irritation Test (OCL-200-EIT) -For the prediction of acute ocular ]irritation of chemicals; for use with MatTek Corporation’s Reconstructed Human EpiOcular^TMModel.

Two tissue replicates were used for each treatment (exposure time of 30 min), including negative and positive controls. The magnitude of viability was quantified by MTT test. Validity of the test method was ascertained by a positive control.

The tissue viability met the acceptance criterion (mean OD of negative control was 1.94). The viability of culture treated by positive control methyl acetate was 46.6%. The positive control met the acceptance criterion: mean tissue viability less than 50%.

The viability of culture treated by 1-Ethyl-3-methylimidazolium bis(trifluoromethylsulfonyl)imide was 101.4%. 

Based on the results of the study, the test item 1-Ethyl-3-methylimidazolium bis (trifluoromethylsulfonyl)imide according to Evaluation criteria and Acceptance criteria is considered to be non-irritant (NI).