Registration Dossier
Registration Dossier
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EC number: 218-746-2 | CAS number: 2224-15-9
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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
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:
- 2,2'-[ethylenebis(oxymethylene)]bisoxirane
- EC Number:
- 218-746-2
- EC Name:
- 2,2'-[ethylenebis(oxymethylene)]bisoxirane
- Cas Number:
- 2224-15-9
- Molecular formula:
- C8H14O4
- IUPAC Name:
- 2,2'-[ethylenebis(oxymethylene)]bisoxirane
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at start of treatment: 11 weeks
- Weight at start of treatment: 2.15-2.21 kg
- Housing: 1 animal / cage, Stainless wire mesh cages (450W x 600D x 360H (mm))
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: during the quarantine-acclimation period, all animals were observed for clinical
signs once daily for 8 days in the initial test and for 10 days in the confirmatory test
ENVIRONMENTAL CONDITIONS
- Temperature (°C): measurement: 19.1–22.1, permissible range: 18.0–24.0
- Humidity (%): measurement: 43.2–54.1, permissible range: 30.0–70.0
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- 0.1 mL
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM:
Draize
TOOL USED TO ASSESS SCORE: slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3.7
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3.7
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3.7
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 13 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 13 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 13 days
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Executive summary:
This study was conducted to evaluate the potential eye irritation/corrosion after a single application of the test substance, 2,2’-[ethylenebis(oxymethylene)]bisoxirane, in three 11 -week-old male New Zealand White rabbits.
0.1 mL of the test substance (100% test substance) was instilled to the conjunctivae sac of the right eye of one animal after gently pulling over the lower eyelid away from the eyeball.
The response scores of the cornea, iris and conjunctivae were recorded according to the method of Draize. In the initial and confirmatory tests, eye irritations were observed at 72 h after test substance application; therefore, additional eye observations were continued up to Day 21. Corneal opacity, redness of the conjunctivae and chemosis of the conjunctivae were observed in all animals until Day 21.
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