Registration Dossier

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:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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

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