Registration Dossier
Registration Dossier
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EC number: 500-322-6 | CAS number: 144086-03-3 1 - 6.5 moles ethoxylated
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: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- 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
- 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:
- Glycerol, ethoxylated, esters with acrylic acid
- 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
Constituent 1
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
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