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EC number: 473-390-7 | CAS number: -
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- Ecotoxicological Summary
- Aquatic toxicity
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- Short-term toxicity to fish
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- Irritation / corrosion
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- Additional toxicological data

Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 2006 to April 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- humidity out of range for protocol. No adverse effect on the study
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 473-390-7
- EC Name:
- -
- Cas Number:
- 1093615-61-2
- Molecular formula:
- C7F15NO
- IUPAC Name:
- 2,2,3,3,5,5,6,6-octafluoro-4-(1,1,1,2,3,3,3-heptafluoropropan-2-yl)morpholine; 2,2,3,3,5,5,6,6-octafluoro-4-(1,1,2,2,3,3,3-heptafluoropropyl)morpholine
- Reference substance name:
- MTDID 7145
- IUPAC Name:
- MTDID 7145
- Details on test material:
- - Name of test material (as cited in study report): MTDID 7145
- Physical state:Liquid
- Analytical purity:~ 94.5%
- Lot/batch no.:142072;43
- Expiration date of the lot/batch: 30 December 2007
- Stability under test conditions: Stable
- Storage condition of test material: Room temperature in the dark
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan, Horst, The netherlands
- Age at study initiation: 9-13 weeks
- Weight at study initiation:2095 to 2638
- Housing:Individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 +/- 3 deg. C.
- Humidity (%): 28-68%
- Air changes (per hr):15
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 1, 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE: after 24 hours
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- 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:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Remarks:
- 24 hours
- Remarks on result:
- other: A weak conjunctival redness score of 1 (0-3) was observed in one animal at the 1 hour examination point. At the next examination at 24 hours, the redness was gone.
- Remarks:
- A weak conjunctival redness score of 1 (0-3) was observed in one animal at the 1 hour examination point. At the next examination at 24 hours, the redness was gone.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- 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:
- animal #2
- 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:
- animal #3
- 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:
- animal #1
- 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:
- animal #2
- 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:
- animal #3
- 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:
- Immediately after dose administration (1 hour), irritation (redness) was observed in the conjunctivae of one animal which completely resolved within 24 hours. No further evidence of irritation was observed in any animal.
- Other effects:
- No mortality occured
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- non-irritating
- Executive summary:
Acute eye irritation/corrosion potential of FC-770 (liquid, batch 142072:43) was evaluated in rabbits following OECD guideline No. 405 (2002) “Acute Eye Irritation/Corrosion.” A single dose of 0.1 mL undiluted test material was placed on the conjunctival sac of one eye of 3 male 6-week old New Zealand White Albino rabbits. The lower lid was gently pulled away from the eyeball for dosing and the lids were gently held together for approximately 1 second to prevent loss. The untreated eye of each animal served as the reference control. Animals were observed for eye irritation at approximately 1, 24, 48 and 72 hours after the instillation of the test substance. Immediately following the 24-hour observation a solution of 2% fluorescein in water was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage. Animals were euthanatized following the last observation. Immediately after dose administration, irritation (redness) was observed in the conjunctivae of one animal which completely resolved within 24 hours. No further evidence of irritation was observed in any animal. There were no observations of ocular corrosion or corneal epithelial damage in any animals. Based on these results FC-770 does not have to be classified and has no obligatory labeling requirement for eye irritation according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (New York and Geneva, 2003) and EC criteria for classification and labeling requirements for dangerous substances and preparations (Council Directive 67/548/EEC).
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