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EC number: 938-677-8 | CAS number: -
- 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:
- 8 May 2002 to 20 May 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- A GLP study performed to a standardised guideline with a sufficient level of detail to assess the quality of the submitted data. The study was conducted with a solution of potassium zirconium carbonate, rather than the pure solid, the results of the study are considered to be the worst case scenario since the solution has a higher pH (ca. 11 vs. 9.2). As such the results are considered to be reliable and suitable for addressing this endpoint.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Protocol Deviations:
- The animals were female instead of male
- Animal care and use committee approval number was 1188/02 instead of 1180/02 (a wrong approval number was written in the study plan)
- Fodder was changed to ensure animal wellbeing during the experiment
- Animal no BWA5 was weighed before dosing but not at the end of the observation period (human error)
None of the deviations were considered to affect the results of the study. - GLP compliance:
- yes
Test material
- Reference substance name:
- Potassium Zirconium Carbonate
- IUPAC Name:
- Potassium Zirconium Carbonate
- Test material form:
- not specified
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Netherlands, Horst
- Weight at study initiation: 2127 - 2339 g
- Housing: individually housed during study
- Diet : Lactamin K-5; Batch100 120 g/day (during study)
- Water: tap water ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 ºC
- Humidity (%): 55 ± 15%
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light
IN-LIFE DATES: From 8 May 2002 to 20 May 2002
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- 0.1 ml undiluted test material was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second. The other eye, which remained untreated, served as a control. - Observation period (in vivo):
- Observation period: 72 hours, however this period was extended for one animal up to day 5.
Following administration, animals were examined for signs of irritation/corrosion after 1, 24, 48 and 72 hours. Observation of ocular reaction was extended for one animal (after dosing) up to 5 days.
Tested animals were observed twice a day (morning and afternoon) for general well being. The animals were observed daily for clinical signs and all clinical signs were recorded. - Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): irrigation was not performed
SCORING SYSTEM: The scoring system presented in the standard guidelines OECD 405 'the grading of ocular lesions' was used to score the reactions observed (see Table 1 in field "Any other information on materials and methods" for further information)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1 d
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 2 d
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 3 d
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- 5 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1 d
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 2 d
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 3 d
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritant / corrosive response data:
- The maximum score for each parameter was calculated using the scoring system presented in the Annex of OECD Guideline No. 405, and as included under the field "Any other information incl. tables".
Application of the test material into the eye caused a mild positive reaction in the conjunctivae tissue of all animals. All the eye reactions were reversible within 5 days. No reactions were observed in the control eye of any of the animals. - Other effects:
- All animals survived in good condition during the study.
The body weight of the test animals was decreased during the observation period but it was considered unlikely to have been test item related.
Any other information on results incl. tables
Table 2: Summary of Eye Reactions
Cornea (score 0-4) | Time period (h) | ||||
Rabbit no. | 1 | 24 | 48 | 72 | Sum |
BWE4 | 0 | 0 | 0 | 0 | 0 |
BWF6 | 0 | 0 | 0 | 0 | 0 |
BWA5 | 0 | 0 | 0 | 0 | 0 |
Sum | 0 | 0 | 0 | 0 | |
Mean | 0 | 0 | 0 | 0 | |
Iris (score 0-2) | Time period (h) | ||||
Rabbit no. | 1 | 24 | 48 | 72 | Sum |
BWE4 | 0 | 0 | 0 | 0 | 0 |
BWF6 | 0 | 0 | 0 | 0 | 0 |
BWA5 | 0 | 0 | 0 | 0 | 0 |
Sum | 0 | 0 | 0 | 0 | |
Mean | 0 | 0 | 0 | 0 | |
Cunjunctivae (score 0-3) | Time period (h) | ||||
Rabbit no. | 1 | 24 | 48 | 72 | Sum |
BWE4 | 0 | 0 | 1 | 0 | 1 |
BWF6 | 1 | 0 | 0 | 0 | 1 |
BWA5 | 1 | 0 | 0 | 0 | 1 |
Sum | 2 | 0 | 1 | 0 | |
Mean | 0.67 | 0 | 0.33 | 0 | |
Chemosis (score 0-4) | Time period (h) | ||||
Rabbit no. | 1 | 24 | 48 | 72 | Sum |
BWE4 | 1 | 1 | 1 | 1 | 4 |
BWF6 | 0 | 1 | 0 | 0 | 1 |
BWA5 | 1 | 1 | 0 | 0 | 2 |
Sum | 2 | 3 | 1 | 1 | |
Mean | 0.67 | 1 | 0.33 | 0.33 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the test, the test material only elicited mild positive conjunctivae reactions in any of the animals during the course of the test that meant that the test material dose not require classification as an eye irritant. The study is considered to be reliable, relevant and adequate for risk assessment and classification and labelling purposes.
- Executive summary:
The eye irritation potential of the test material was determined in accordance with the standardised guidelines OECD 405. 0.1 ml of the test material was applied into one of each eye of three rabbits. The rabbits were observed for up to 5 days to determine the grade of ocular reaction to the test material. All tested animals had a mild positive reaction to the test material which were fully reversible within 5 days.
Under the conditions of the test, the test material was considered to be not irritating to the unrinsed eye. The test material does not require classification for eye irritation in line with Regulation No. 1272/2008.
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