Registration Dossier
Registration Dossier
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EC number: 445-090-6 | CAS number: 5614-37-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02 March 2002 - 19 March 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to OECD, EC, and US EPA test guidelines, and in compliance with GLP; on this basis the study is considered reliable without restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 445-090-6
- EC Name:
- -
- Cas Number:
- 5614-37-9
- Molecular formula:
- C6 H12 O
- IUPAC Name:
- Cyclopentyl methyl ether
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Analytical purity: 99.8%
- Lot/batch No.: 010912
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: At least 13 weeks
- Weight at study initiation: 2.8 to 3.1 kg
- Housing: Metal cages with perforated floors
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least 16 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19±2°C
- Humidity (%): 30 to 70%
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark
IN-LIFE DATES: From: 02 March 2002 To:19 March 2002
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- N/A (following instillation of the test material, the eye lids were held together for 1 second before release).
- 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): Not performed
SCORING SYSTEM: Refer to tables below.
TOOL USED TO ASSESS SCORE: handheld light
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 Days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- (All animals)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No corneal damage observed in any animal
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- (All animals)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: No iridial observed in any animal
- Other effects:
- There were no signs of toxicity or ill health in any rabbit during the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- A single instillation of the substance into the eye of the rabbit elicited well-defined to considerable conjunctival irritation.
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