Registration Dossier
Registration Dossier
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EC number: 613-739-4 | CAS number: 65039-09-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-ethyl-1-methyl-1H-Imidazolium chloride (1:1)
- EC Number:
- 613-739-4
- Cas Number:
- 65039-09-0
- Molecular formula:
- C6 H11 N2 . Cl
- IUPAC Name:
- 3-ethyl-1-methyl-1H-Imidazolium chloride (1:1)
- Reference substance name:
- 1-Ethyl-3-methyl-1-imidazolium chloride (EMIM CI)
- IUPAC Name:
- 1-Ethyl-3-methyl-1-imidazolium chloride (EMIM CI)
- Details on test material:
- - Name of the test substance used in the study report: 1-Ethyl-3-methyl-1-imidazolium chloride (EMIM CI)
- pH-value: ca. 5 (undiluted test substance moistened with water)
- Analytical purity: 97.4 g/100 g
- Lot/batch No.: EMIMCI 31F221105
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Centre Lago S. A., 01540 Vonnas, France
- Age at study initiation: ca. 6 months
- Weight at study initiation: 0: 3.60 kg – 3.70 kg
- Housing: Single housing in stainless steel wire mesh cages with grating, floor area: 3000 cm2.
- Diet (e.g. ad libitum): Kliba-Labordiaet (Kaninchen & Meerschweinchenhaltung “GLP”), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland (about 130 g/animal per day)
- Water (e.g. ad libitum): ad libitum, Tap water
- Acclimation period: at least 5 days before application
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 – 24°C
- Humidity (%): 30 – 70%
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal
- Amount / concentration applied:
- 0.1 mL bulk volume (about 74 mg) of the undiluted semi-solid test substance
The solid test substance was heated at about 85°C for better handling. Before application, the test substance was cooled down to body temperature. At this temperature the test substance was semi-solid and could be applied with a sharp spoon. - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Single instillation into the conjunctival sac of the right eyelid.
About 24 hours after application of the test substance the treated eye of the animals was rinsed with 3 to 6 mL of hand-warm tap water for 1 to 2 minutes using a syringe with a blunt probe.
Readings: Approx. 1, 24, 48 and 72 h after application and then in weekly intervals maximally up to day 28.
Body weight determination just before application of the test substance and after the last reading.
A check for any dead or moribund animal was made twice each workday (at the beginning and end of work) and once daily at weekends and on public holidays.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0.1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 1.1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
Any other information on results incl. tables
Readings |
Animal |
Cornea |
Iris |
Conjunctiva |
Additional findings |
|||
Opacity |
Area of cornea involved |
Redness |
Chemosis |
Discharge |
||||
1 h |
01 |
0 |
0 |
0 |
2 |
2 |
3 |
49 |
02 |
0 |
0 |
0 |
2 |
3 |
3 |
|
|
03 |
0 |
0 |
0 |
2 |
3 |
3 |
|
|
24 h |
01 |
0 |
0 |
0 |
2 |
2 |
2 |
48 |
02 |
0 |
0 |
0 |
2 |
1 |
0 |
48 |
|
03 |
0 |
0 |
1 |
2 |
2 |
2 |
PC, 48 |
|
48 h |
01 |
0 |
0 |
0 |
2 |
1 |
0 |
48 |
02 |
0 |
0 |
0 |
2 |
1 |
0 |
48 |
|
03 |
0 |
0 |
0 |
2 |
1 |
1 |
48 |
|
72 h |
01 |
0 |
0 |
0 |
2 |
1 |
0 |
48 |
02 |
0 |
0 |
0 |
2 |
0 |
0 |
48 |
|
03 |
0 |
0 |
0 |
2 |
1 |
0 |
48 |
|
7 d |
01 |
0 |
0 |
0 |
0 |
0 |
0 |
|
02 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
03 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
Mean 24 – 72 h |
01 |
0.0 |
|
0.0 |
2.0 |
1.3 |
|
|
02 |
0.0 |
|
0.0 |
2.0 |
0.7 |
|
|
|
03 |
0.0 |
|
0.3 |
2.0 |
1.3 |
|
|
|
Mean |
|
0.0 |
|
0.1 |
2.0 |
1.1 |
|
|
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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