3-methyl-1-vinyl-1H-imidazolium methyl sulphate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

08.09.2011-17.04.2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD 431; OECD 439

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

3-methyl-1-vinyl-1H-imidazolium methyl sulphate

EC Number:

247-832-2

EC Name:

3-methyl-1-vinyl-1H-imidazolium methyl sulphate

Cas Number:

26591-72-0

Molecular formula:

C6H9N2.CH3O4S

IUPAC Name:

1-ethenyl-3-methyl-1H-imidazol-3-ium methyl sulfate

Details on test material:

- Name of test material (as cited in study report): 3-Methyl-1-vinyl-1 H-imidazolium methyl sulfate
- Physical state: solid
- Analytical purity: 99.97 area-%
- Lot/batch No.: 77761968E0
- Expiration date of the lot/batch:
- Stability under test conditions: The stability under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.
- Other: Test substance number: 11/0584-1

Test animals

Species:

other: human reconstructed epidermis

Strain:

other: not applicable

Details on test animals or test system and environmental conditions:

not applicable

Test system

Type of coverage:

other: not applicable

Preparation of test site:

other: not applicable

Vehicle:

other: Highly de-ionized water (corrosion test); PBS, sterile (irritation test)

Controls:

other: not applicable

Amount / concentration applied:

The test substance was applied undiluted.

Duration of treatment / exposure:

corrosion test: 3 min and 1 hour
irritation test: 1 hour

Observation period:

corrosion test: 0 hours (The assay medium was replaced by MTT solution after treatment and tissues were incubated for 3 hours.)
irritation test: 42 hours (After rinsing, tissue were incubated at 37°C for 24 hours in medium. After 24 hours tissues were once again transferred into fresh medium and incubated for additional 18 hours. Afterwards, medium was replaced by MTT solution for the viability testing)

Number of animals:

Corrosion test: 2 tissues
Irritation test: 3 tissues

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The tissues were washed with PBS to remove residual test material

SCORING SYSTEM:
Corrosive potential of the test materials is predicted from the mean relative tissue viabilities obtained after 3 min treatment compared to the negative control tissues concurrently treated with highly de-ionized water
Mean tissue viability (% of negative control)
3 min: < 50 = corrosive
3 min: ≥ 50 and 1 hour: < 15 = corrosive
3 min: ≥ 50 and 1 hour: ≥ 15 = non-corrosive

Although the method is not finally validated for categorizing the severity of corrosivity according to certain classification and labeling systems, it is suggested to use the most stringent category for test substances leading to viabilities below 50% after 3 min treatment.

Irritant potential of the test materials is predicted from the mean relative tissue viabilities after 1 hour with a post-incubation time of 42 hours compared to the negative control tissues concurrently treated with sterile PBS. A chemical is considered as "irritant", if the mean relative tissue viability with a test material is less than or equal to 50%.
Mean tissue viability (% of negative control)
≤ 50 = irritant
> 50 = non-irritant

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

other: other: mean OD570 values (as measures of the viability in % compared to control) test item, corrosion test

Value:

97 - 102

Remarks on result:

other:

Remarks:

Basis: mean 2 tissues. Time point: 3 min or 1 hour. Remarks: Corrosion test: Mean tissue viability (% of negative control): 3 min: < 50 = corrosive; 3 min: ≥ 50 and 1 hour: < 15 = corrosive; 3 min: ≥ 50 and 1 hour: ≥ 15 = non-corrosive . (migrated information)

Results 2

Irritation / corrosion parameter:

other: other: mean OD570 values (as measures of the viability in % compared to control) test item, irritation test

Value:

118

Remarks on result:

other:

Remarks:

Basis: mean 3 tissues. Time point: 42 hours. Remarks: Irritation test: Mean tissue viability (% of negative control) ≤ 50 = irritant; > 50 = non-irritant . (migrated information)

Any other information on results incl. tables

Corrosion test data after 3 min

Test substance	Mean OD 570	Viability [% of negative control]
Negative control	1.87	100
11/0584 -1	1.818	97
Positive control	0.244	13

Corrosion test data after 1 hour

Test substance	Mean OD 570	Viability [% of negative control]
Negative control	1.709	100
11/0013-1	1.741	102
Positive control	0.192	11

Irritation data

Test substance	Mean OD 570	Viability [% of negative control]
Negative control	1.711	100
11/0013-1	2.026	118
Positive control	0.095	6

The tissue viability is calculated as the quotient of the mean OD570 and the respecitve OD570 of the negative control (in percent). Acceptance criteria for the positive control (corrosion test: viability < 30% and irritation test: viability < 20%) were reached in both tests. Corrosive potential of the test materials is predicted from the mean relative tissue viabilities obtained after 3 min treatment compared to the negative control tissues concurrently treated with highly de-ionized water. A chemical is considered as "corrosive", if the mean relative tissue viability after 3 min treatment with a test material is decreased below 50%. In addition, those materials with a viability of ≥ 50% after 3 min treatment are considered as "corrosive" if the mean relative tissue viability after 1 hour treatment with a test material is decreased below 15%.

Irritant potential of the test materials is predicted from the mean relative tissue viabilities compared to the negative control tissues concurrently treated with sterile PBS. A chemical is considered as "irritant", if the mean relative tissue viability with a test material is less than or equal to 50%.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information

Executive summary:

The potential of 3-Methyl-1-vinyl-1 H-imidazolium methyl sulfate to cause dermal corrosion/irritation was assessed by a single topical application of the test substance to a reconstructed three dimensional human epidermis model (EpiDerm™). Because the viscous test substance could not be applied with a pipette or sharp spoon, a metal pin was covered with about 122 mg of the undiluted test substance. For the corrosion test two EpiDerm™ tissue samples were incubated with the test substance for 3 minutes and 1 hour, respectively. The irritation test was performed with three EpiDerm™ tissue samples, which were incubated with the test substance for 1 hour followed by a 42-hours post-incubation period. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the testsubstance treated epidermal tissues is compared to that of negative control tissues. The quotient of the values indicates the relative tissue viability. The EpiDerm™ skin corrosivity/irritation test showed the following results: The test substance is not able to reduce MTT directly. Corrosion test: The mean viability of the test-substance treated tissues determined after an exposure period of 3 minutes was 97%, and it was 102% after an exposure period of 1 hour. Irritation test: The mean viability of the test-substance treated tissues determined after an exposure period of 1 hour with about 42 hours post-incubation was 118%. Based on the observed results and applying the evaluation criteria it was concluded, that 3-Methyl-1-vinyl-1 H-imidazolium methyl sulfate does not show a skin irritation potential in the EpiDerm™ skin corrosion/irritation test under the test conditions chosen.