Registration Dossier
Registration Dossier
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EC number: 206-596-0 | CAS number: 355-93-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 May 2007 to 31 October 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- The study was not commissioned with compliance with REACH as a goal, rather the study was commissioned during early product development.
Test material
- Reference substance name:
- 2,2,3,3,4,4,5,5-octafluoropentyl methacrylate
- EC Number:
- 206-596-0
- EC Name:
- 2,2,3,3,4,4,5,5-octafluoropentyl methacrylate
- Cas Number:
- 355-93-1
- Molecular formula:
- C9H8F8O2
- IUPAC Name:
- 2,2,3,3,4,4,5,5-octafluoropentyl 2-methylprop-2-enoate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 08230AB
- Purity: 99.8%
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kuiper Rabbit Ranch (Gary, IN)
- Age at study initiation: 4 months of age
- Weight at study initiation: 2.84-3.09 kg
- Housing: housed individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.9 - 21.2°C
- Humidity (%): 27-401%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 16 May 2007 To: 24 May 2007
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 mL of undiluted test substance
- Duration of treatment / exposure:
- single exposure; the treated eye of each rabbit was rinsed with water 24 hours after dosing.
- Observation period (in vivo):
- 1, 24, 48, 72-hours after test substance administration
- Duration of post- treatment incubation (in vitro):
- Not applicable
- Number of animals or in vitro replicates:
- 3 animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: the treated eye of each rabbit was rinsed with water
- Time after start of exposure: 24 hours after dosing.
SCORING SYSTEM: according to EEC grading guidelines
TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- animal: 1, 2, 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- probability of weak irritation
- Remarks:
- conjunctiva discharge score of 1 at 1 hour in 1 animal
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Slight, clear fluid was discharged on the fur below the eye of two animals at the 1-hour time point. The animals were recovered from the signs of discharge at the 24-hour time point.
- Other effects:
- Throughout the study, no deaths occurred and none of the animals were found moribund.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The mean eye irritation score at 24, 48, and 72 hours for corneal opacity, iris lesion, conjunctival redness and chemosis were all 0 for 3 animals.
- Executive summary:
Undiluted test substance was placed in the conjunctival sac of the right eye of each of the three female rabbits used in the study. The untreated left eye of each rabbit served as a control for comparison purposes. The treated eye of each rabbit was rinsed with water 24 hours after administration of the test substance and scored for irritation at 1, 24, 48, and 72 hours post-dose.
Slight, clear fluid was discharged on the fur below the eyes of two animals at the 1-hour scoring interval. The rabbits completely recovered from signs of ocular discharge at the 24-hour scoring interval.
The mean scores for corneal opacity, iris lesion, conjunctival redness and chemosis were all 0.
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