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 guideline study

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

Constituent 1
Chemical structure
Reference substance name:
Glycerol, ethoxylated, esters with acrylic acid
EC Number:
500-322-6
EC Name:
Glycerol, ethoxylated, esters with acrylic acid
Cas Number:
144086-03-3
Molecular formula:
UVCB substance
IUPAC Name:
[(uraniovanadio)methyl]borane
Details on test material:
- Name of test material (as cited in study report): Glycerin3EOTA
- Physical state: Liquid / beige, turbid
- Analytical purity: >99%
- Lot/batch No.: GK0561/160
- Stability under test conditions: The stability under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.
- Storage condition of test material: Room temperature
- Other: pH ca. 5

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., France
- Age at study initiation: 4 - 5 months
- Weight at study initiation: 3.06 kg
- Housing: Single housing in stainless steel wire mesh cages with grating, floor area: 3000 cm2
- Diet: Kliba-Labordiaet (Kaninchen & Meerschweinchenhaltung "GLP"), Provimni Kliba SA, Switzerland (about 130 g/animal per day)
- Water (e.g. ad libitum): Tap water
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
Amount applied: 0.1 ml
Duration of treatment / exposure:
24 hour(s)
Observation period (in vivo):
28 d
Number of animals or in vitro replicates:
1
Details on study design:
Comment: rinsed after (see exposure time)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): About 24 hours after application of the liquid test substance the treated eye of the animal(s) was rinsed with 3 to 6 mL of hand warm tap water for 1 to 2 minutes using a syringe with a blunt probe


SCORING SYSTEM: Draize


TOOL USED TO ASSESS SCORE: Daylight tubes "Lumilux" (L 58W/860 PLUS ECO 25X1, Osram, Germany)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24 - 48 - 72 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: score 3 in readings of d7 to d28; involved area score was 4 on h48 and h72 readings, score 2 on d7 and d14 readings, and score 1 on d21 and d28 readings
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24 - 48 - 72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 14 d
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24 - 48 - 72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 21 d
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24 - 48 - 72 h
Score:
3.33
Max. score:
4
Reversibility:
fully reversible within: 21 d
Irritant / corrosive response data:
At the 1h reading, the index for corneal opacity, area and Iris could not be read because of severe swelling
At the 24h reading, the index for Iris and area could not be read because of severe swelling
Other effects:
Discharge (score 3) was completely reversible within 14 days

Any other information on results incl. tables

Additional findings were:

Discharge of blood: readings 24h – 7d

Pupil contracted: readings 48h – 7d

Suppuration: readings 48h – 7d

Small retraction in the eyelid: readings 7d – 28d

Loss of corneal tissue: readings 7d – 21d

Vascularization of the cornea, circumscribed area, marginal: reading 7d

Vascularization of the cornea, circumscribed area, into the central part: reading 14d – 28d

Scleral vessels injected, circumscribed area: reading 21d

Scleral vessels injected, circular: readings 7d, 14d and 28d

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Remarks:
Migrated information