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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12. September 2017 - 04. January 2018

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:

2018

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

Version / remarks:

Guideline No. 439 adopted 28 July 2017

Deviations:

yes

Remarks:

this deviation is considered as without impact on the concluion of the study

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)

Version / remarks:

Test method B.46 of Council regulation No. 761/2009 dated 23 July 2009 (EU Journal L220) - ATP Council regulation No. 761/2009 dated 23 July 2009 (EU Journal L220) - ATP Council regulation No. 440/2008 of 30 May 2008 (EU Journal L142)

Deviations:

yes

Remarks:

this deviation is considerd as without impact on the conclusion of the study

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:

- Source and lot/batch No.of test material: 25PI208_12; PA204
- Expiration date of the lot/batch: May 2019
- Purity test date: 99,84 wt%

- Storage condition of test material: room temperature, dry place

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

other: 0,5 cm² reconstructed epidermis of normal human keratinocytes

Cell source:

foreskin from a single donor

Details on test system:

0,50 cm² reconstructed epidermis (Episkin SA, RHE/S/17 Batch no. 17-RHE-104)
growth medium (Episkin SA, Batch No. 17 SGM 026)
maintenance medium (Episkin SA, Batch No. 17 SMM 016)

Control samples:

yes, concurrent negative control

yes, concurrent positive control

yes, concurrent MTT non-specific colour control

Amount/concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 16µL


NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 16 µL


POSITIVE CONTROL
- Amount(s) applied (volume or weight): 16 µL
- Concentration (if solution): 5% SDS

Duration of treatment / exposure:

42 minutes at room temperature, recovered with a nylon mesh provided by Episkin SA

Number of replicates:

3 living human skin models

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

3

Value:

109.1

Negative controls validity:

valid

Remarks:

Mean viability 100%

Positive controls validity:

valid

Remarks:

Mean viability 1,8%

Other effects / acceptance of results:

- OTHER EFFECTS:
- Visible damage on test system: no
- Direct-MTT reduction: yes
- Colour interference with MTT: no


ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
- Acceptance criteria met for variability between replicate measurements: yes
- Range of historical values if different from the ones specified in the test guideline: no

Any other information on results incl. tables

ASSESMENT OF THE SKIN IRRITATION

INDIVIDUAL AND AVERAGE VALUES OF OD AFTER 42 MINUTES EXPOSURE

TEST ITEM: 1 -Ethyl-3 -methylimidazolium bis(trifluoromethylsulfonyl)imide

Application: 16µL of the test item on 0.50 cm² human skin model

Application dates: 03.October 2017

Skin  OD  Mean OD / disc (#)  Mean OD / product  Viability %  Mean Viability %  SD viability  Conclusion  Negaive Control        1 0.772 0.824 0.834  0.810        0.653  124.0        100.0        20.8          2  0.555 0.595 0.587  0.579  88.6  3  0.542 0.591 0.579  0.571  87.4        Positive control  4  0.014 0.018 0.015  0.016        0.012  2.4        1.8        0.6        Irritant  5 0.011 0.010 0.010  0.011  1.7  6 0.009 0.008 0.008  0.009  1.4        Test item PH-17/0490  7 0.688 0.854 0.780  0.774        0.713  118.5        109.1        10.8        Non irritant  8 0.757 0.724 0.704  0.729  111.6  9 0.639 0.640 0.627   0.636  97.3

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In accordance with the Regulation EC No. 1272/2008, the test item 1-Ethyl-3-methylimidazolium bis(trifluoromethylsulfonyl)imide has to be considered as Non-irritant to skin. It corresponds to UN GHS No Category.
No hazard statement or signal word is required.

Executive summary:

The aim was to evaluate the possible irritating effects of the test item 1-Ethyl-3 -methylimidazolium bis(trifluoromethylsulfonyl)imide after topical application on in vitro human reconstructed epidermis (SkinEthic RHE model)

The test item 1-Ethyl-3 -methylimidazolium bis(trifluoromethylsulfonyl)imide was applied as supplied, at the dose of 16 µL, to 3 living Reconstructed Human eoidermis (SkinEthic RHE model) during 42 minutes. The application was followed by rinse with 25 mL of DPBS and a 42 hours and 40 minutes post-incubation period at 37°C, 5% CO₂.Cell viability was then measured by enzymatic conversion of the vital dye MTT into a blue formazan salt that was quantitatively measured after extraction from tissues. The experimental protocol was established in accordance with OECD Test Guideline No. 439 adopted 28 July 2015 and the Test methode B.46 of Council regulation No. 761/2009 dated 23 July 2009 (EU Journal L220) - ATP Council regulation No. 440/2008 of 30 May 2008 (EU Journal L142)

The mean percent viability of the treated tissues was 109.1% (considered as 100 %), versus 1.8% in the positive control (5% Sodium Dodecyl Sulfate)