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EC number: 238-485-8 | CAS number: 14484-69-6
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guideline study, no restrictions, fully adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Aluminum potassium fluoride
- EC Number:
- 262-153-1
- EC Name:
- Aluminum potassium fluoride
- Cas Number:
- 60304-36-1
- Details on test material:
- Identification: KALIUMTETRAFLUOROALUMINAT
Description: colourless powder
Batch number: 0136A
Purity/Formulation: Assay of F 51.4% (47-53%), Al 17.7% (14-18%)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Test system: New Zealand White Rabbit, SpF
- Rationale: Recognized by the international guidelines as the recommended test system
- Source: Elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne / France
- Age at start of treatment: 14 weeks (male), 14-16 weeks (females)
- Body weights at start of treatment: 2.7 to 3.1 kg
- Acclimatization: Seven days under laboratory conditions after health examination, only animals without any visual signs of illness were used for the study.
- Conditions: Standard Laboratory Conditions. The animal room was air-conditioned with 10-15 air changes per hour. The air was continuously monitored for temperature and relative humidity. The ranges for room temperature and relative humidity were 21-23.5 oC and approximately 39-75%, respectively. The animals were provided with an automatically controlled light cycle of 12 hours light and l2 hours dark. Music was played during the light cycle.
- Accommodation: Individually in stainless steel cages
- Diet: ad libitum
- Water: ad libitum
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: right eye served as the reference control
- Amount / concentration applied:
- 0.1 g (left eye only)
- Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 1 male and 2 females
- Details on study design:
- Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours, as well as 7, 10, 14, 17 and 21 days after test item application. The scores of each animal at the following reading times (24, 48 and 72 hours) were used in calculating the respective mean values for each type of lesion.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: primary irritation score
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 4.33
- Max. score:
- 13
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 17 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- Diffuse corneal opacity was seen in all animals at the 1-hour examination and persisted through 72 hours before disappearing at 7 days (one animal), 10 days (one animal) or 21 days (one animal). Slight reduced light reflex of the iris was noted in one animal at the 1-hour examination. Hyperemic blood vessels of the conjunctivae and nictitating membrane were observed in all animals 1 hour after treatment and increased in severity through 72 hours before diminishing to clear by day 10 (one animal), 14 (one animal) or 17 (one animal).
Obvious swelling of the conjunctivae and nictitating membrane with partial eversion of lids or with lids about half-closed was observed in all animals at the 1-hour reading before diminishing by day 7 (one animal), 10 (one animal) or 14 (one animal).
A red ring of blood vessels was observed in all animals above the iris at the 7-day reading and persisted in two animals at the 10-day reading before disappearing in only one animal 14 days after treatment.
The sclera was not visible in all animals at 1 hour due to the swelling. A slightly reddened sclera was observed in all animals at the 24-hour reading and increased in severity in one animal at the 48-hour reading whereas the sclera was not visible in the two other animals due to the mucous production in the treated eye. When the sclera of one animal was not visible, a moderately reddened sclera was seen in the two other animals at 72 hours. Slightly to markedly reddened sclera was observed in all animals from 7 to 17 days after treatment and still persisting on test day 21 in two animals.
No staining of the treated eyes by the test item was observed.
No corrosion was observed at any of the measuring intervals.
All eye reactions were not clear 21 days after treatment.
Applicant's summary and conclusion
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