Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
gas under pressure: refrigerated liquefied gas
Details on test material:
- Name of test material (as cited in study report): DEGD, Bis (2-ethoxyethyl) ether
- Substance type: Solvent for toner
- Physical state: Colourless liquid
- Analytical purity:99.95 (GC%)
- Lot/batch No.:2E09WA
- Expiration date of the lot/batch:31 December 2012
- Stability under test conditions:
- Storage condition of test material: Refrigerator (ca.4C) in the dark
- Other:

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: respected breeders
- Age at study initiation:36 or 39 weeks
- Weight at study initiation:3.80 to 4.38 kg
- Housing: housed individually in a plastic cage with perforated floors
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period:21 or 22 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C):16 to 20°C
- Humidity (%):40 to 70%.
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12hrs/12hrs

IN-LIFE DATES: From: 26 October 2012 To: 15 November 2012

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye of each animal remained untreated
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml


Duration of treatment / exposure:
The eyelids were then gently held together for one second before releasing. The substance was not removed and the eyes were not washed.
Observation period (in vivo):
Ocular reactions to treatment were assessed 1, 24, 48 and 72 hours and eight days after treatment
Number of animals or in vitro replicates:
Three rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:

SCORING SYSTEM: according to the system of Kay and Calandra (1962)

TOOL USED TO ASSESS SCORE: An ophthalmoscope or pencil beam torch was available for use to facilitate inspection of the eyes.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 1, 24, 48, 72h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 1, 24, 48, 72h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 1, 24, 48, 72h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 1, 24, 48, 72h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 1, 24, 48, 72h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1, 24, 48, 72h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48h
Remarks on result:
other: Redness of conjunctiva - Mean score following grading at 24, 48 and 72 hours after instillation of the test material
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 1, 24, 48, 72h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: Redness of conjunctiva - mean scores following grading at 24, 48 and 72 hours after instillation of the test material
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 1, 24, 48, 72h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: Redness of conjunctiva - mean scores following grading at 24, 48 and 72 hours after instillation of the test material
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1, 24h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48h
Remarks on result:
other: mean scores following grading at 24, 48 and 72 hours after instillation of the test material
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 1, 24h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48h
Remarks on result:
other: mean scores following grading at 24, 48 and 72 hours after instillation of the test material
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 1, 24, 48, 72h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: mean scores following grading at 24, 48 and 72 hours after instillation of the test material

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

Injection of the conjunctival blood vessels and very slight or slight chemosis was evident in all animals during the first 24 hours following instillation; in two cases the conjunctival injection persisted throughout the first 72 hours after instillation. Slight or moderate discharge was apparent in all animals one hour after instillation. The treated eye of one animal was overtly normal by 48 hours after instillation and in the remaining two animals on Day 8. However, DEDG did not require labelling in accordance with European Commission regulation 1272/2008.