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EC number: 240-985-6 | CAS number: 16923-95-8
- 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
Endpoint summary
Administrative data
Description of key information
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
- Study period:
- 1996-11-26 to 1996-12-03
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study reliable with restrictions - the stability was missing in the study report.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- , 1992-07-17
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed 1996-02-27
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: twelve to sixteen weeks old
- Weight at study initiation: 2.38 to 2.62 kg
- Housing: the animals were individually housed in suspended metal cages.
- Diet (ad libitum): STANRAB SQC Rabbit Diet, Special Diets Services Ltd, Witham, Essex, UK
- Water (ad libitum): mains drinking water
- Acclimation period: minimum acclimatisation period of five days
ENVIRONMENTAL CONDITIONS
- Temperature: 17 to 19°C
- Relative humidity: 49 to 64%
- Air exchanges: approximately fifteen changes per hour
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): a quantity of 0.5 g of the test material, moistened with distilled water was applied.
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL of distilled water - Duration of treatment / exposure:
- 4 hours
- Observation period:
- approximately one hour following the removal of the patches, and 24,48 and 72 hours later as well as on Day 7
- Number of animals:
- 3 male rabbits
- Details on study design:
- TEST SITE
- Area of exposure and type of wrap if used: on the day before the test each rabbit was clipped free of fur from the dorsal flank area using veterinary clippers. Only animals with a healthy intact epidermis by gross observation were selected for the study.
On the day of the test a suitable test site was selected on the back of each rabbit. A quantity of the test material, moistened with distilled water, was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin. The patch was secured in position with a strip of surgical adhesive tape (BLENDERM: approximate size 2.5 cm x 4.0 cm). To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset (TUBIGRIP) and the animals were returned to their cages for the duration of the exposure period.
REMOVAL OF TEST SUBSTANCE
- Washing: the corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: four hours after application
SCORING SYSTEM: according to the Draize scale
Any other skin reactions, if present, were also recorded.
If irreversible alteration of the dermal tissue is noted in any rabbit, which may include ulceration and clear necrosis or signs of scar tissue, the test material is classified as corrosive to rabbit skin. - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Very slight erythema was noted at one treated skin site at the 24, 48 and 72-hour observations. No other evidence of erythema was noted.
No evidence of oedema was noted.
No evidence of skin irritation was noted at two treated skin sites during the study.
No corrosive effects were noted. - Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material is non-irritating to the skin of rabbits.
According to 67/548/EC and subsequent regulations, dipotassium hexafluorozirconate is not classified as a skin irritant.
According to the EC Regulation No. 1272/2008 and subsequent regulations, dipotassium hexafluorozirconate is not classified as a skin irritant.
Reference
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
- Study period:
- 1996-12-09 to 1996-12-10
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study reliable with restrictions - the stability was missing in the study report.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987-02-24
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed 1996-02-27
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: twelve to sixteen weeks old
- Weight at study initiation: 2.70 kg
- Housing: the animal was housed in a suspended metal cage.
- Diet (ad libitum): STANRAB SQC Rabbit Diet, Special Diets Services, Witham, Essex, UK
- Water (ad libitum): mains drinking water
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature: 18 to 19°C
- Relative humidity: 49 to 56%
- Air exchanges: approximately fifteen changes per hour
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): a volume of 0.06 mL of the test material, which was found to weigh approximately 100 mg (as measured by gently compacting the required volume into an adapted syringe) was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after application, to prevent loss of the test material, and then released. The left eye remained untreated and was used for control purposes. - Duration of treatment / exposure:
- not applicable
- Observation period (in vivo):
- approximately 1 and 24 hours following treatment
- Number of animals or in vitro replicates:
- one male rabbit
- Details on study design:
- Immediately before the start of the test, both eyes of the provisionally selected test rabbit were examined for evidence of ocular irritation or defect with the aid of a light source from as standard ophthalmoscope.
SCORING SYSTEM: according to the Draize scale
Any other ocular effects were also recorded.
Immediately after administration of the test material, an assessment of the initial pain reaction was made.
If the rabbit shows irreversible ocular damage the test material will be classified as corrosive to the eye.
TOOL USED TO ASSESS SCORE: examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope. - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Opacity of cornea covered an area greater than three quarters, up to whole area.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24 hour
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Due to showing signs of pain and discomfort (i.e. holding head to one side and abnormally quiet) the animal was killed for humane reasons after the 24-hour observation. Opacity of cornea covered an area greater than three quarters, up to whole area.
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- other: Pupil abnormally small in appearance.
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24 hour
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- other: Due to showing signs of pain and discomfort (i.e. holding head to one side and abnormally quiet) the animal was killed for humane reasons after the 24-hour observation. Pupil abnormally small in appearance.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other: Petechial haemorrhage of nictitating membrane.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24 hour
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other: Due to showing signs of pain and discomfort (i.e. holding head to one side and abnormally quiet) the animal was killed for humane reasons after the 24-hour observation. Haemorrhage of conjunctival membranes; pale appearance of nictitating membrane.
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Discharge with moistening of the lids and hairs a considerable area around the eye.
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24 hour
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Due to showing signs of pain and discomfort (i.e. holding head to one side and abnormally quiet) the animal was killed for humane reasons after the 24-hour observation. Discharge with moistening of the lids and hairs a considerable area around the eye.
- Irritant / corrosive response data:
- Diffuse corneal opacity was noted in the treated eye one hour after treatment with translucent corneal opacity noted at the 24-hour observation. Iridial inflammation was noted in the treated eye one hour after treatment and at the 24-hour observation.
Moderate conjunctival irritation was noted in the treated eye one hour after treatment with severe conjunctival irritation at the 24-hour observation.
Petechial haemorrhage of the nictitating membrane was noted in the treated eye one hour after treatment. Haemorrhage of the nictitating membrane and conjunctival membranes of upper and lower eyelids was noted at the 24-hour observation. The nictitating membrane appeared pale and the pupil abnormally small at this time.
Due to showing signs of pain and discomfort (i.e. holding head to one side and abnormally quiet) the animal was killed for humane reasons after the 24-hour observation, in accordance with company policy and current UK Home Office guidelines. - Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material is considered to cause serious damage to the eyes of rabbits.
According to 67/548/EC and subsequent regulations, dipotassium hexafluorozironate is classified as being a risk of causing serious damage to the eyes (R41).
According to the EC Regulation No. 1272/2008 and subsequent regulations, dipotassium hexafluorozironate is classified as Category 1.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
According to a reliable, guideline conform study (OECD 404), dipotassium hexafluorozirconate is not irritating or corrosive to skin.
According to a reliable, guideline conform study (OECD 405), dipotassium hexafluorozirconate causes serious damage to the eye.
Justification for selection of skin irritation / corrosion endpoint:
Key study.
Justification for selection of eye irritation endpoint:
Key study.
Effects on eye irritation: corrosive
Justification for classification or non-classification
According to a reliable, guideline conform study (OECD 404), dipotassium hexafluorozirconate is not irritating or corrosive to skin. No classification for skin irritation/corrosion is required.
According to a reliable, guideline conform study (OECD 405), dipotassium hexafluorozirconate causes serious damage to the eye. Consquently, dipotassium hexafluorozirconate is classified for irreversible effects on the eye (Category 1), according to Regulation (EC) No 1272/2008.
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