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EC number: 243-053-7 | CAS number: 19430-93-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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Endpoint summary
Administrative data
Description of key information
No respiratory irritation was observed in rats exposed to 2000 ppm (20123 mg/m3) PFBE (3,3,4,4,5,5,6,6,6-nonafluorohexene) in a 28-day repeated exposure inhalation toxicity study.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline equivalent study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
- Species:
- rabbit
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 24 hrs
- Observation period:
- 48 hrs
- Number of animals:
- 6
- Details on study design:
- Six male albino rabbits were clipped free of hair on the trunk and lateral area and placed in FDA-type stocks. Doses of 0.5 ml of undiluted test material were applied to intact skin under 1 ½ inch x 1 ½ inch 12-ply gauze squares. Rubber sheeting was then loosely wrapped around the trunk and secured with adhesive tape. After 24 hours, the rabbits were removed from the stocks, the patches taken off and the reactions observed. Observations were also made at 48 hours.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- PFBE (3,3,4,4,5,5,6,6,6-nonafluorohexene) caused no skin irritation in 24 or 48 hrs when tested on the shaved intact skin of 6 male rabbits.
- Executive summary:
PFBE (3,3,4,4,5,5,6,6,6-nonafluorohexene) caused no skin irritation in 24 or 48 hrs when tested on the shaved intact skin of 6 male rabbits.
Reference
Table 1: Results of PFBE Skin Irritation Test in Rabbits.
24-Hour Observation |
48-Hour Observation |
||
Erythema |
Oedema |
Erythema |
Oedema |
None 6/6 |
None 6/6 |
None 6/6 |
None 6/6 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.1 ml
- Observation period (in vivo):
- 3-days
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- 0.1 ml of undiluted test material was placed into the right conjunctival sac of each of 2 male New Zealand White Rabbits. After 20 seconds, 1 treated eye was washed with tap water for 1 minute. The treated eye of the other rabbit was not washed. Observations of the cornea, iris and conjunctiva were made with an ophthalmoscope at 1 and 4 hours, and at 1, 2 and 3-days. Fluor-I-strip® and a slit lamp biomicroscope were used at examinations after the day of treatment.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- PFBE (3,3,4,4,5,5,6,6,6-nonafluorohexene) may produce slight to mild eye irritation.
- Executive summary:
PFBE (3,3,4,4,5,5,6,6,6-nonafluorohexene) caused slight corneal clouding and mild conjunctivitis in a treated rabbit eye. It caused slight corneal clouding and slight conjunctivitis in an eye, when treated and promptly washed. Both washed and unwashed eyes were normal 2 days after treatment.
PFBE (3,3,4,4,5,5,6,6,6-nonafluorohexene) may produce slight to mild eye irritation.
Reference
Table 1: Results of PFBE Eye Irritation Test in the Rabbit
Dose |
Treatment |
Ocular Effects |
||
Cornea |
Iris |
Conjunctiva |
||
0.1 ml |
Not washed |
General area of slight clouding at 1 hr; decreasing to a small area at 4 hr |
No involvement |
Redness:None Swelling:Slight 1 – 4 hr Discharge:Mild at 4 hr |
0.1 ml |
Washed |
Small area of slight clouding at 1 hr decreasing to a local area 4 hr – 1 day |
No involvement |
Redness:None Swelling:Slight 1 – 4 hr Discharge:None |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
1) In a dermal irritation/corrosion study to a protocol equivalent/similar to OECD Test Guideline 404, PFBE (3,3,4,4,5,5,6,6,6-nonafluorohexene) caused no irritation to the shaved intact skin of six male rabbits.
2) In an acute eye irritation/corrosion study to a protocol equivalent or similar to OECD Test Guideline 405, PFBE (3,3,4,4,5,5,6,6,6-nonafluorohexene) caused slight corneal clouding and mild conjunctivitis in a treated rabbit eye. It caused slight corneal clouding and slight conjuctivitis in an eye when treated and promptly washed, . Both washed and unwashed eyes were normal 2 days (48 hr) after treatment. As a result, PFBE (3,3,4,4,5,5,6,6,6-nonafluorohexene) was judged to be a slight/mild irritant to the eye.
Justification for selection of skin irritation / corrosion endpoint:
Study conducted to a protocol equivalent/similar to OECD Guideline 404
Justification for selection of eye irritation endpoint:
Study conducted to a protocol equivalent/similar to OECD Guildline 4
Effects on eye irritation: slightly irritating
Justification for classification or non-classification
In a dermal irritation/corrosion study to a protocol equivalent/similar to OECD Test Guideline 404, PFBE (3,3,4,4,5,5,6,6,6-nonafluorohexene) caused no irritation to the shaved intact skin of six male rabbits. Therefore classification for skin irritation/corrosion is not warranted according to EU Directive 67/548/EEC or the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
In an acute eye irritation/corrosion study to a protocol equivalent or similar to OECD Test Guideline 405, PFBE (3,3,4,4,5,5,6,6,6-nonafluorohexene) caused slight corneal clouding and mild conjunctivitis in a treated rabbit eye. It caused slight corneal clouding and slight conjuctivitis in an eye when treated and promptly washed. Both washed and unwashed eyes were normal 2 days (48 hr) after treatment. As a result, PFBE (3,3,4,4,5,5,6,6,6-nonafluorohexene) was judged to be a slight/mild irritant to the eye. Since the effects had totally disappeared after 48 hrs, the mean scores for corneal opacity and conjuctivitis graded at the 24hr, 48hr and 72hrs after treatment were likely to be <1. Therefore the irritant effects observed were not sufficently severe for PFBE (3,3,4,4,5,5,6,6,6-nonafluorohexene) to be classified as Irritating to Eyes (Category 2) according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008. Similarly, classification as Irritating to Eyes (R38) is not warranted according to EU Directive 67/548/EEC.
No respiratory irritation was observed in rats exposed to 2000 ppm (20123 mg/m3) PFBE (3,3,4,4,5,5,6,6,6-nonafluorohexene) in a 28-day repeated exposure inhalation toxicity study. Therefore, classification for respiratory irritation is not warranted according to EU Directive 67/548/EEC or the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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