Registration Dossier
Registration Dossier
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EC number: 500-066-5 | CAS number: 28961-43-5 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:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- ethoxylated trimethylolpropane triacrylate (TMPeoTA)
- IUPAC Name:
- ethoxylated trimethylolpropane triacrylate (TMPeoTA)
- Reference substance name:
- Propylidynetrimethanol, ethoxylated, esters with acrylic acid
- EC Number:
- 500-066-5
- EC Name:
- Propylidynetrimethanol, ethoxylated, esters with acrylic acid
- Cas Number:
- 28961-43-5
- Molecular formula:
- n.a.
- IUPAC Name:
- Poly(oxy-1,2-ethanediyl),.alpha.-hydro-.omega.-[(1-oxo-2- propenyl)oxy]-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1)
- Details on test material:
- - Physical state: liquid
- Analytical purity: > 83 %
- Lot/batch No.: B40071
- Stability under test conditions: The stability of the test substance was confirmed by reanalysis
- Storage condition of test material: room temperature, exclusion of light
Constituent 1
Constituent 2
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: 3-4 months
- Weight at study initiation: 2.65-2.80 kg
- Housing: individually
- Diet: ca. 130 g/animal/day (Kliba-Labordiät)
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C
- Humidity (%): 30-70 %
- Air changes (per hr): fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- single application; substance was washed out after 24 hours
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 24 hours
SCORING SYSTEM: according to OECD guideline 405
TOOL USED TO ASSESS SCORE: light
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.56
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.11
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
Any other information on results incl. tables
The mean individual scores of the animals (24/48/72 hours) were:
corneal opacity: 1 in 3/3 animals
iris: 0 in 1/3 animals, 0.67 in 1/3 animals and 1.33 in 1/3 animals
redness of the conjunctivae: 2.33 in 1/3 animals; 2.67 in 2/3 animals
chemosis: 1.67 in 1/3 animals, 2.33 in 2/3 animals
Due to the overall and individual mean scores observed, the test substance has to be classified as irritating to eye (R36) according to EU- and as eye irritant Cat. 2A according to GHS-criteria.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Indication of an irritant property to the eye
- Executive summary:
The potential of "confidential substance name" to cause damage to the conjunctiva, Iris or cornea was assessed in 3 White New Zealand rabbits, subjected to a single ocular application of 0.1 ml of the test substance according to OECD 405.
The ocular reactions were assessed approximately 1, 24, 48 and 72 hours after application and then in weekly intervals until day 14.
Slight to severe conjunctival redness, slight to marked conjunctival swelling and slight to severe discharge were observed during the course of the study. Slight corneal opacity was observed in all animals and moderate or severe iritis was noted in two animals during the observation period.
The ocular reactions were reversible in all animals within 14 days after application. The average score (24 to 72 hours) for irritation was calculated to be 1.0 for corneal opacity, 0.7 for iris, 2.6 for conjunctival redness and 2.1 for chemosis.
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