Registration Dossier
Registration Dossier
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EC number: 433-480-9 | CAS number: 623-53-0
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: Guideline followed is similar to OECD 405 and was performed under GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: According to the requirements of the Japanese Ministry of Agriculture, Forestry and Fisheries (MAFF), Testing Guidelines for Toxicology Studies, 59 NohSan No. 4200.
- Principles of method if other than guideline:
- The guideline followed is similar to OECD guideline 405.
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 433-480-9
- EC Name:
- -
- Cas Number:
- 623-53-0
- Molecular formula:
- C4 H8 O3
- IUPAC Name:
- ethyl methyl carbonate
- Test material form:
- other: liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK.
- Age at study initiation: 12-16 weeks old
- Weight at study initiation: 2.68 - 3.16 kg
- Housing: housed individually in suspended metal cages.
- Diet: RABMA Rabbit Diet ad libitum
- Water: mains drinking water ad libitum
- Acclimation period: minimum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 22
- Humidity (%): 44 - 56
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- 0.1 ml (instilled into the conjunctival sac of the right eye). The left eye was not treated and served as the control.
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- Prior to the start of the test, both eyes of each test animal were examined for evidence of ocular irritation or defect. Initially only one rabbit was treated with a volume of 0.1ml instilled into the conjunctival sac of the right eye. The left eye was untreated and served as the control. Immediately after administration, an assessment of the initial pain reaction was made. Upon this assessment, the remaining 5 test animals were treated with one drop of local anaesthetic (Ophthaine, 0.5% proxymetacaine hydrochloride) to minimise pain before instillation of the test material.
Assessment of ocular damage/irritation was made at 1, 24, 48 and 72 hours after treatment and evaluated according to the method of Draize.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 4.8
- Max. score:
- 110
- Reversibility:
- fully reversible
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0.3
- Max. score:
- 110
- Reversibility:
- fully reversible
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 0
- Max. score:
- 110
- Reversibility:
- fully reversible
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 110
- Reversibility:
- fully reversible
Any other information on results incl. tables
No corneal effects were observed during the study. Iridial inflammation was observed in one treated eye 1 hour after treatment, but no other iridial effects were noted. Minimal to moderate conjunctival irritation were observed in all treated eyes an hour after treatment. In one eye conjunctival redness persisted to the 24 -hour observation. All treated eyes appeared normal 24 -48 hours post-treatment.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the eye irritation potential of ethyl methyl carbonate has been assessed and has been determined to not be irritating to the eyes.
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