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Registration Dossier
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EC number: 236-752-3 | CAS number: 13474-25-4
Toxicological information
Skin sensitisation
Currently viewing:
Administrative data
- 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.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- 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.
Test material
- 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:
- 3-methyl-1-vinyl-2,3-dihydro-1H-imidazol-1-ium methyl sulfate
Constituent 1
In vivo test system
Test animals
- 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
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- 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
Challengeopen allclose all
- 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
Results and discussion
- 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.
In vivo (non-LLNA)
Resultsopen allclose all
- 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.
Applicant's summary and conclusion
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