1H-Imidazolium, 3-ethyl-1-methyl-, ethyl sulfate (1:1)

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: Guideline study (OECD 405)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Details on test material:

- Physical apprearance: Light yellow viscous liquid
- Batch: 99/484
- Storage: RT in the dark
- Stability undert storage conditions: not indicated
- Specific gravity: 1.23
- Purity: 99% (HPLC)
- Stability under storage conditions: 10th June 2005 (allocated by NOTOX, 1 year after receipt of the test substance)

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: 7- 9 weeks
- Sex: male
- Weight at study initiation: > 1.3 kg
- Housing: individually
- Diet : Standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits, Al tromin, Lage, Germany) approx. 100 g per day. In addition, hay (BMI, Helmond, the Netherlands) was provided at least three times a week .
- Water: Free access to tap-water
- Acclimation period: =>5 days. A health inspection was performed prior to commencement of treatment, to ensure that the animals were in a good state of health. Special a ttention was paid to the eyes, which were free from any abnormalit.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.2-22.3
- Humidity (%): 33-59
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: other eye

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml

Duration of treatment / exposure:

24

Observation period (in vivo):

The eyes of each animal were examined approximately 1, 24, 48 and 72 hours after Instillation of the test substance.

Number of animals or in vitro replicates:

3

Details on study design:

The study was designed as such that, first a single rabbit (sentinel) was treated. The two other animals were treated in a similar manner 5 days later, after considering the degree of skin irritation observed in the first animal.

Each animal was treated by instillation of 0.1 ml of the test substance in the conjunctival sac of one of the eyes after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test substance. The other eye remained untreated and served as the reference control. Any bright green stained area, indicating epithelial damage, was estimated as a percentage of the total corneal area.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with water containing 2% fluorescein adjusted to pH7
- Time after start of exposure: 24

SCORING SYSTEM: Draize scoring

OBSERVATION
- Mortality: twice daily
- Toxicity: at least once daily
- Body weight measurements: day of treatment (prior to appliation) and the termination

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

for all 3 animals

Time point:

other: 24 + 48 +72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

for all 3 animals

Time point:

other: 24 + 48+ 72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of all 3 animals

Time point:

other: 24 + 48 + 72 h

Score:

0.5

Max. score:

4

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of all 3 animals

Time point:

other: 24 + 48 + 72 h

Score:

0.1

Max. score:

4

Other effects:

No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Any other information on results incl. tables

Table 1: Individual and Mean Value Irritation scores

Readings	Animal	Cornea Opacity	Iris	Conjunctiva Redness	Swelling
1h	1	0	1	1	2
	2	0	1	2	1
	3	0	0	2	2
24h	1	0	0	1	0
	2	0	0	2	0
	3	0	0	1	1
48h	1	0	0	0	0
	2	0	0	1	0
	3	0	0	0	0
72h	1	0	0	0	0
	2	0	0	0	0
	3	0	0	0	0
Mean (24h-72h)	1	0,0	0,0	0,3	0,0
	2	0,0	0,0	1,0	0,0
	3	0,0	0,0	0,3	0,3
Mean (24h-72h)	all animals	0,0	0,0	0,6	0,1

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU