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EC number: 244-479-6 | CAS number: 21615-47-4
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 Feb - 05 Apr 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted in 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- adopted in 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- adopted in Nov 2000
- Deviations:
- not specified
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted in 2015
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Ammonium undecafluorohexanoate
- EC Number:
- 244-479-6
- EC Name:
- Ammonium undecafluorohexanoate
- Cas Number:
- 21615-47-4
- Molecular formula:
- C6H4F11NO2
- IUPAC Name:
- 2,2,3,3,4,4,5,5,6,6,6-Undecafluorohexanoic acid, ammonium salt (1:1)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- (SPF-Quality)
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: 9 - 11 weeks
- Weight at study initiation: 2.049 - 2.330 kg (range)
- Housing: individually in cages with perforated floors (56x44x37.5 cm)
- Diet: standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Lage, Germany) approx. 100 g per day, additionally pressed hay three times a week
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16.5 - 24.7
- Humidity (%): 29 - 78
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The other eye of each animal remained untreated and served as the reference control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 28 days
reading time points: 1, 24, 48 and 72 h and 7, 14, 21 days (and/or 28 days in the sentinel animal) - Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: fluorescein; Where standard lighting was considered inadequate for observing minor effects, eye examinations were performed using an ophthalmic examination lamp.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: a 20% aqueous solution of the test substance was used
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: a 20% aqueous solution of the test substance was used
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: a 20% aqueous solution of the test substance was used
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: a 20% aqueous solution of the test substance was used
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: a 20% aqueous solution of the test substance was used
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: a 20% aqueous solution of the test substance was used
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 28 days
- Remarks on result:
- other: a 20% aqueous solution of the test substance was used
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: a 20% aqueous solution of the test substance was used
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: a 20% aqueous solution of the test substance was used
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: a 20% aqueous solution of the test substance was used
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: a 20% aqueous solution of the test substance was used
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: a 20% aqueous solution of the test substance was used
- Irritant / corrosive response data:
- The corneal injury consisted of opacity (maximum grade 2) in all animals and epithelial damage (maximum fluor area 35%, 65% and 50% of the corneal area). In 2/3 animals corneal injury was reversible within 7 days and persisted until day 21 in the remaining animal. lridial irritation (grade 1) was observed in all animals and was reversible within 72 hours in 1/3 animals and within 7 days in the two remaining animals. The irritation of the conjunctivae consisted of redness (maximum grade 3), chemosis (maximum grade 4) and discharge (maximum grade 3). Redness had completely resolved within 21 and 28 days in 2/3 animals, respectively, and persisted until termination (day 21) in the remaining animal. Chemosis and discharge had completely resolved within 7 days in all animals.
- Other effects:
- - Lesions and clinical observations: As a result of the corneal injury, pannus (neovascularisation of the cornea) was apparent in 1/3 animals 7 and 21 days after instillation. Reduced elasticity of the eyelids was noted in all animals 24 and/or 48 hours and/or 7 days after instillation.
- Other observations: No staining of (peri) ocular tissues by the test substance was observed and no test substance remnants were seen.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Any other information on results incl. tables
Table 1: Results of eye irritation study.
Alteration |
Animal No. |
Time (h) |
|||||
1 |
24 |
48 |
72 |
mean 24/48/72 h |
reversible within |
||
Cornea (opacity) |
1 |
1 |
2 |
1 |
1 |
1.3 |
7 days |
2 |
1 |
1 |
1 |
1 |
1.0 |
7 days |
|
3 |
1 |
1 |
1 |
1 |
1.0 |
Not reversible within 21 days |
|
Area of corneal opacity * |
1 |
1 |
1 |
2 |
1 |
- |
- |
2 |
3 |
3 |
3 |
2 |
- |
- |
|
3 |
3 |
2 |
2 |
2 |
- |
- |
|
Iris |
1 |
0 |
0 |
1 |
1 |
0.7 |
7 days |
2 |
1 |
1 |
1 |
0 |
0.7 |
72 h |
|
3 |
1 |
1 |
1 |
1 |
1.0 |
7 days |
|
Conjunctivae Redness |
1 |
2 |
2 |
3 |
3 |
2.7 |
28 days |
2 |
2 |
3 |
3 |
3 |
3.0 |
Not reversible within 28 days |
|
3 |
2 |
3 |
3 |
3 |
3.0 |
21 days |
|
Conjunctivae Chemosis |
1 |
4 |
3 |
2 |
1 |
2.0 |
7 days |
2 |
3 |
3 |
2 |
1 |
2.0 |
7 days |
|
3 |
3 |
2 |
2 |
1 |
1.7 |
7 days |
*Area of cornea involved:
0 = No ulceration or opacity
1 = One quarter or less but not zero
2 = Greater than one quarter, but less than half
3 = Greater than half, but less than three quarters
4 = Greater than three quarters, up to whole area
Applicant's summary and conclusion
- Interpretation of results:
- other: Eye damage Cat. 1 according to Regulation (EC) No 1272/2008
- Conclusions:
- Under the conditions of this eye irritation study in rabbits the test substance was corrosive to the eye. Although a 20% aqueous solution of the test substance was used in this study, results are considered valid as corrosive properties can also be assumed for the pure test substance. Thus, the test substance is classified as Eye Dam. 1 (H318) according to Regulation (EC) No 1272/2008.
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