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Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1997-02-25 and 1997-03-21
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP-conform study according to OECD guideline and EU method. The purity of the test substance analogue was only 46.4%. For read-across justification, please refer to section 13.
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
1996
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
A reliable guinea pig test was already available.
Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River GmbH - Wiga, Kisslegg, Germany
- Age at study initiation: yound adult animals
- Weight at study initiation: 326 - 378 g
- Housing: Animals were housed in groups of five.
- Diet: ad libitum (Kliba Labordiät 341; Klingentalmühle AG, Kaiseraugust, Switzerland)
- Water: ad libitum (tap water; about 2 g of ascorbic acid per 10 L water was added to the drinking water twice a week)
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
- intradermal injection: 5% test substance concentration
- epidermal application: undiluted test substance
- epidermal, challenge: 75% test substance concentration
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
- intradermal injection: 5% test substance concentration
- epidermal application: undiluted test substance
- epidermal, challenge: 75% test substance concentration
No. of animals per dose:
control group: 5
test group: 10
Details on study design:
RANGE FINDING TESTS:
A. EPIDERMAL APPLICATION:
- Concentrations: 100%, 75%, 50% and 25% test substance
- Site of application: flank, on the same area respctively
- Number of animals: 4 per test concentration
- Time of exposure: 2 times for 24 hours within a period of 96 hours
- Observation point after exposure: 24 and 48 hours

B. INTRDERMAL INJECTIONS:
- A 5 % test substance preparation in 0 .9 % aqueous NaCl-solution resp. in Freund's adjuvant / 0 .9 % aqueous NaCl solution (1 : 1) was injected with a syringe .
- signs of skin irritation was assessed after 24 hours

MAIN STUDY
A.1 INDUCTION EXPOSURE (intradermal)
- Exposure period: 2 injections each of 0.1 mL/site
- Test groups: (A) 1:1 mixture of FCA and 0.9% aqueous NaCl-solution, (B) 5% test substance in 0.9% aqueous NaCl-solution, (C) 5% test substance in 1:1 mixture of FCA and 0.9% aqueous NaCl-solution
- Control group: were treated as described for the experimental animals but without test substance, only with the formulating agent
- Site: shoulder (front row, middle row, back row)
- Duration: single injection

A.2 INDUCTION EXPOSURE (epidermal), 7 days after intradermal induction
- Test group: undiluted test substance
- Control group: were not treated, since the test substance was applied undiluted and thus no solvent was used
- Site: shoulder
- Duration: 48 hours

B. CHALLENGE EXPOSURE; 14 days after percutaneous induction
- No. of exposures: 1
- Exposure period: 24 hours
- Test groups and control group 1: were treated with 75% test substance in aqua bidest; control group 2 remaind untreated
- Site: intact flank
- Evaluation (hr after challenge): 24 and 48 hours
Challenge controls:
Yes
Positive control substance(s):
no
Positive control results:
The positive control with Alpha-Hexylcinnamaldehyde techn. 85% showed that the test system was able to detect sensitizing compounds under the laboratory conditions chosen.
Reading:
1st reading
Hours after challenge:
24
Group:
other: control group
Dose level:
75%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
one animal died during the experiment
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: control group. Dose level: 75%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: one animal died during the experiment.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: control group
Dose level:
75%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
one animal died during the experiment
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: control group. Dose level: 75%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: one animal died during the experiment.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
75%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
75%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 75%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The test substance analogue 3 -methyl-1-vinylimidazolium methosulfat was tested for its sensitizing effects on the skin of the guinea pig in the Maximization test based on the method of Magnusson and Kligman.Ten test and five control animals were used for the main study. Based on the results of a range-finding study, the concentrations of the test material analogue for the induction and challenge phase were selected as follows: intradermal induction (5% in 0.9% aqueous NaCl-solution or in FCA/0.9% aqueous NaCl-solution (1:1) or 0.9% aqueous NaCl-solution), percutaneous induction (undiluted test substance analogue), challenge (75% in aqua bidest.). The intradermal induction with 5% test substance analogue preparations caused slight to well-defined signs of skin irritation in all test group animals. After the percutaneous induction with the undiluted test substance incrustation, partially open (caused by the intradermal induction) could be observed in addition to well-defined erythema and slight edema in all test group animals. No skin reactions were noted at the challenge sites of the test or control group animals at the 24 or 48 -hour observations. Thus, the test material analogue produced a 0% (0/10) sensitisation rate and was classified as a non-sensitiser to guinea pig skin.  


Migrated from Short description of key information:
The test article analogue 3-methyl-1-vinylimidazolium methosulfat does not have a sensitizing effect on the skin of the guinea pig in the maximization test under the test conditions chosen.

Justification for selection of skin sensitisation endpoint:
Only one reliable study, which is GLP-conform and in accordance to OECD guideline.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)
The available study is considered reliable and suitable for classification purposes under 67/548/EEC. As a result the test substance is not considered to be classified for skin sensitisation under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EG.

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the test substance is not considered to be classified for skin sensitisation under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation EC 605/2014.