Registration Dossier
Registration Dossier
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EC number: 202-510-0 | CAS number: 96-49-1
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 14 -December 15, 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study was performed according to following guidelines: OECD 405, EU Method B.5, EPA OPPTS 870.2400 and in compliance with the GLP Regulations. No significant deviations can be observed from the study guidelines, which could have an impact on the performance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- stability not reported
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Ethylene carbonate
- EC Number:
- 202-510-0
- EC Name:
- Ethylene carbonate
- Cas Number:
- 96-49-1
- Molecular formula:
- C3H4O3
- IUPAC Name:
- 1,3-dioxolan-2-one
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): Ethylene carbonate
- Purity: > 99%
- Physical state: fine crystals
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Limited, Margate, Kent, UK.
- Age at study initiation: young adults
- Weight at study initiation: 2.969-3.914 kg
- Housing: individually, in cages suitable for animals of this strain and the weight range expected during the course of the study.
- Diet (e.g. ad libitum): Diet (STANRAB SQC), supplied by Special Diet Services Limited, Witham, Essex, UK, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: min.5d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C±3°C
- Humidity (%): 30-70
- Air changes (per hr): a minimum of 15 changes/hour,
- Photoperiod (hrs dark / hrs light): 12h dark/12h light
IN-LIFE DATES: From: 20 Nov 2000 To: 15 Dec 2000
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: OECD 405: untreated eye of the test animal serves as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Duration of treatment / exposure:
- 1-2 seconds
- Observation period (in vivo):
- 10 days
- Number of animals or in vitro replicates:
- 3 (1 male and 2 females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with water
- Time after start of exposure: 1 day
SCORING SYSTEM: observation
Draize and a modified form of the Kay and Calendra scoring system
TOOL USED TO ASSESS SCORE: fluorescein staining
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal 98
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal 106
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal 107
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal 98
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal 106
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal 107
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal 98
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal 106
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal 107
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- Animal 98
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal 106
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal 107
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritant / corrosive response data:
- Additional signs of irritation consisted of oedematous, erythematous or convoluted eyelids; lachrymatory or Harderian discharge; haemorrhage of
the nictitating membrane; dried secretion around the periorbital skin and eyelids closed due to discharge.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- JEFFSOL Ethylene Carbonate is a moderate irritant (class 5 on a 1-8 scale) to the rabbit eye. According to the criteria specified in the CLP Regulation (EC) No 1272/2008, JEFFSOL Ethylene Carbonate should be classified as an eye irritant substance category 2 (reversible eye effects).
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