1,2-dimethyl-3-propyl imidazolium bis((trifluoromethyl)sulfonyl)amide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18 MAY 2016 to 20 MAY 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 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

Version / remarks:

adopted 28 july 2015

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

No. 761/2009 dated 23 july 2009 (Eu Journal L220) - ATP Council regulation No. 440/2008 of 30 May 2008 (Eu journal L142)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

GROUPE INTERMINISTERIEL DES PRODUITS CHIMIQUES, France

Test material

Test material information

Constituent 1

Reference substance name:

1,2-dimethyl-3-propyl imidazolium bis((trifluoromethyl)sulfonyl)amide

EC Number:

805-807-9

Cas Number:

169051-76-7

Molecular formula:

C10H15F6N3O4S2

IUPAC Name:

1,2-dimethyl-3-propyl imidazolium bis((trifluoromethyl)sulfonyl)amide

Test material form:

liquid

Details on test material:

Appearance : colorless oil
Composition: a base stock containing (C, 28.64; H, 3.61; F, 27.18; N, 10.02; O, 15.26; S, 15.29)
Molecular formula : C10H15F6N3O4S2
Molecular Weight : 419.12 g/mol
Purity >99% (purity determined by MNR)
Homogeneity : homogeneous

Specific details on test material used for the study:

Batch : L16-0169
Production date of the batch : 2016-01-07
expiration date of the Batch : 2030-01-02
storage : room temperature

In vitro test system

Test system:

human skin model

Remarks:

Episkin SA, RHE/S/17/batch No. 16-RHE-051

Details on test system:

SKIN DISC PREPARATION
- Procedure used: Upon receipt, the insert (filter + epidermis) was gently removed from the agarose and placed in a 6 wells culture plate wich had been previously filled with 1 mL of growth medium (Episkin SA) during 2 hours and 40 minutes. then just brefore the treatment, the inserts were placed in 24 wells culture plate wich had been previously filled with 300 µl of maintenace medium (Episkin SA).
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature
- Temperature of post-treatment incubation : 37°C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Number of washing steps: 25
- Observable damage in the tissue due to washing: the tissues were noted to be whitish, comparable coloration to that of the negative control tissues.
- Modifications to validated SOP: No
DYE BINDING METHOD
- Dye used in the dye-binding assay: MTT
- Spectrophotometer:
- Wavelength: 570 nm
- The measurement of OD was performed using the ELx800 absorbance microplate reader supplied by BioTek and the validated software Gen5 ELISA v1.05.11 supplied by Biotek.
NUMBER OF INDEPENDENT TESTING RUNS / EXPERIMENTS TO DERIVE FINAL PREDICTION: The OD was measured in triplicate of MTT extract.
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test item is considered to be non irritant to skin: if the viability after 42 minutes of exposure and 42 hours of post-treatment incubation is > 50%.
- The test item is considered to be irritant to skin: if the tissue viability after 42 minutes of exposure and 42 hours of post-treatment incubation is ≤ 50%.

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

TEST MATERIAL
- The test item 1-Propyl-2,3-Dimethylimidazolium bis(trifluoromethanesulfonyl)imide was applied as supplied, at the dose of 16 µl.

NEGATIVE CONTROL
- 16 µl of DPBS - PAN BIOTECH Gmbh

POSITIVE CONTROL
- 16 µl of 5% SDS

Duration of treatment / exposure:

42 minutes

Duration of post-treatment incubation (if applicable):

42 hours

Number of replicates:

3

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Value:

117.8

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Other effects / acceptance of results:

Acceptability criteria : The standard deviation for the % of viability obtained in the three treated epidermises was 34.4 %, instead of ≤ 18%, as scheduled. Considering the results obtained, this deviation is considered as without impact on the conclusion of this study.

Any other information on results incl. tables

TEST ITEM : 1-Propyl-2,3-Dimethylimidazolium bis(trifluoromethanesulfonyl)imide

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

^{Application date : 18 May 2016}

^{Table 1}

	Skin	OD	Mean OD / disc (≠)	Mean OD/ product	Viability %	Mean viability %	SD	conclusion
Negative control	1	1.021 1.073 1.080	1.058	0.917	115.4	100.0	13.3
	2	0.800 0.888 0.840	0.843		91.9
	3	0.839 0.856 0.856	0.850		92.7
Positive control	4	0.020 0.023 0.023	0.022	0.020	2.4	2.1	0.4	Irritant
	5	0.016 0.016 0.015	0.016		1.7
	6	0.021 0.022 0.019	0.021		2.3
Test item PH-16 /0216	16	1.393 1.246 1.175	1.271	1.080	138.6	117.8	34.4	Non irritant
	17	1.337 1.240 1.185	1.254		136.8
	18	0.795 0.800 0.553	0.716		78.1

Notes

• If the viability obtained for the test item is greater than 50 %, the test item has to be considered as non irritant.
• If the viability obtained for the test item is less than or equal to 50 %, the test item has to be considered as irritant.

# : mean of 3 values (triplicate of the same extract)

OD : optical density

The optical density was measured after a 1:2 dilution of the formazan extracts in isopropanol.

Accceptability criteria : SD ≤ 18%

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-Propyl-2,3-Dimethylimidazolium bis(trifluoromethanesulfonyl)imide has to be considered as Non-irritant to skin in accordance with UN GHS Category. No hazard statement or signal word is required.

Executive summary:

The aim of the study was to evaluate the possible irritating effects of the test item 1-Propyl-2,3-Dimethylimidazolium bis(trifluoromethanesulfonyl)imide after topical administration on in vitro human reconstructed epidermis (SkinEthic model).

The test item 1-Propyl-2,3-Dimethylimidazolium bis(trifluoromethanesulfonyl)imide was applied as supplied, at dose of 16 µl, to 3 Reconstructed human epidermis (SkinEthic RHE model) during 42 minutes, followed by a rinse with 25 ml of PBD and a 42 hours 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 O.E.C.D Test Guidelines N°439 adopted 28 july 2015 and the test method 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 (E.U. Journal L142).

The mean percent viability of the treated tissues was 117.8%, versus 2.1% in the positive control (5% Sodium Dodecyl Sulfate).

In accordance with the regulation EC NO. 1272/2008, the test item  1-Propyl-2,3-Dimethylimidazolium bis(trifluoromethanesulfonyl)imide has to be considered as Non-irritant to skin in accordance with UN GHS Category.

No hazard statement or signal word is required.