Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
13. Oct. 2004 - 21. Oct. 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
460-100-9
EC Name:
-
Cas Number:
342573-75-5
Molecular formula:
Hill formula: C8H16N2O4S CAS formula: C6H11N2.C2H5O4S
IUPAC Name:
3-ethyl-1-methyl-1H-imidazol-3-ium ethyl sulfate

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Species : Albino Rabbit, New Zealand White, (SPF-Quality); Recognised by international guidelines as the recommended test system (e.g. EC, OECD). Source : Charles River Deutschland, Kisslegg, Germany
Number of animals : 3 males
Age and body weight : Animals used within the study were at least 6 weeks old and body weights were at least 1.0 kg.
Identification : Earmark.
Animal Husbandry
Conditions : Animals were housed in a controlled environment, in which optimal conditions were considered to be approximately 15 air changes per hour, a temperature of 21.0 ± 3.0°C (actual range: 20.2 - 22.3°C), a relative humidity of 30-70% (actual range: 33 - 59%) and 12 hours artificial fluorescent light and 12 hours darkness per day.
Accommodation : Individually in labelled cages with perforated floors (Scan bur, Denmark, dimensions 56x44x37.5 cm). Acclimatisation period was at least 5 days before start of treatment under laboratory conditions.
Diet : Standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Lage, Germany) approx. 100 g. per day. Certificates of analysis were examined and retained in the NOTOX archives. In addition, hay (BMI, Helmond, the Netherlands) was provided at least three times a week.
Water : Free access to tap-water. Certificates of quarterly analysis were examined and retained in the NOTOX archives.
Results of analysis for ingredients and/or contaminants of diet and water were assessed and did not reveal any findings that were considered to have affected study integrity.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
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.
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
The eyes of each animal were examined approximately 1, 24, 48 and 72 hours after instillation of the test substance. The irritation scores and a description of all other (local) effects were recorded
Number of animals or in vitro replicates:
3
Details on study design:
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. Immediately after the 24-hour observation, a solution of 2% fluorescein in water (adjusted to pH 7.0) was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage. Any bright green stained area, indicating epithelial damage, was estimated as a percentage of the total corneal area.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: mean 24 -72 hours
Score:
0.32
Max. score:
1
Reversibility:
fully reversible within: 72 hours

Any other information on results incl. tables

MEAN VALUE EYE IRRITATION SCORES:

Animal no.

Mean 24 – 72 hours

Age at start

Body weight

Corneal opacity

Iris

Conjunctivae

Start

Termination

Redness

Chemosis

271

0.0

0.0

0.3

0.0

 

1611

1750

287

0.0

0.0

1.0

0.0

 

1341

1509

289

0.0

0.0

0.3

0.3

 

1353

1466

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on these results and according to the:
- OECD Harmonized Integrated Hazard Classification System for Human Health and Environmental Effects of Chemical Substances (OECD, 1998), 1-ETHYL-3-METHYL IMIDAZOLIUM ETHYLSULFATE does not have to be classified for eye irritation.
- EC criteria for classification and labelling requirements for dangerous substances and preparations (Council Directive 67/548/EEC), 1-ETHYL-3-METHYL IMIDAZOLIUM ETHYLSULFATE (EMIM ES) does not have to be classified and has no obligatory labelling requirement for eye irritation.
Executive summary:

Acute eye irritation/corrosion study with 1-ETHYL-3-METHYL IMIDAZOLIUM ETHYLSULFATE in the rabbit.

The study was carried out based on the guidelines described in: - OECD No 405 (2002) "Acute Eye Irritation / Corrosion" - EC Commission Directive, Annex 5, B.5, (2004) "Acute Toxicity: Eye Irritation / Corrosion" - EPA, OPPTS 870.2400 (1998): "Acute Eye Irritation" - JMAFF guidelines (2000). Single samples of 0.1 ml of 1-ETHYL-3-METHYL IMIDAZOLIUM ETHYLSULFATE were instilled into one eye of each of three rabbits. Observations were made 1, 24, 48 and 72 hours after instillation. Instillation of the test substance resulted in effects on the iris and conjunctivae. Iridial irritation grade 1 was observed and had resolved within 24 hours. The irritation of the conjunctivae consisted of redness, chemosis and discharge and had completely resolved within 48 hours in two animals and within 72 in the other animal.

Based on these results and according to the:

- OECD Harmonized Integrated Hazard Classification System for Human Health and Environmental Effects of Chemical Substances (OECD, 1998), 1-ETHYL-3-METHYL IMIDAZOLIUM ETHYL..SULFATE (EMIM ES) does not have to be classified for eye irritation.

- EC criteria for classification and labelling requirements for dangerous substances and preparations (Council Directive 67/548/EEC), 1-ETHYL-3-METHYL IMIDAZOLIUM ETHYLSULFATE (EMIM ES) does not have to be classified and has no obligatory labelling requirement for eye irritation. -