Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 8 May 2002 to 17 May 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- A GLP study performed to standardised guidelines 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 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Protocol Deviations:
- Dosing was performed twice for animals BWR9 and BWN5 during the exposure period to ensure a close contact between the test material and the skin
- Animals dosed were female instead of male
- To ensure the well being of the animals during the study the food was changed
These deviations were considered to have no effect on the outcome 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Netherlands, Horst
- Weight at study initiation: 2059-2191 g
- Housing: individually housed during study
- Diet: Lactamin K-5; Batch100 120 g/day
- Water: tap water ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 ºC
- Humidity (%): 55 ± 15%
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
On the day before application of the test material each rabbit was prepared by clipping the hair from the back and sides using a hair clipper. The exposure area was 2.5 cm x 2.5 cm and was marked using a water-resistant marker before dosing. On the day of dosing, a dose of 0.5 ml of test material was applied to a gauze patch. The test area was covered with the gauze patch and was held in place with a non-irritating tape. Animals were restrained in a restraining table during the exposure period to prevent the animals from reaching the exposed skin area.
0.5 ml of test material was applied again on the patch (animals BWR9 and BWN5) two hours after the first application.
POSITIVE CONTROL
The positive control used was the reference item 1% dodecylsulfat (SDS). 0.5 ml of 1% SDS was applied to the gauze patch under the same conditions as the test material. As with the test material, 0.5 ml 1% SDS was re-applied to the gauze patch 2 hours after the first application. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 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. Animals were examined for signs of erythema and oedema at 1, 24, 48 and 72 hours after patch removal.
- Number of animals:
- 4 (3 were treated with test material and 1 recieved a dose of the positive control, dodecylsulfat- SDS)
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: non-irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): washing was not performed
SCORING SYSTEM: Dermal irritation/corrosion was scored and recorded according to the grading of skin reaction according to OECD Guideline 404. The scoring system used in the study is presented in Table 1 in the field "Any other information on materials and methods incl. tables"
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1 day
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1, 2 and 3 days
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1, 2 and 3 days
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Animal BWR9 had a very slight erythema 60 minutes after patch removal. The positive skin reaction was reversible within 1 day. The observed positive skin reactions for the reference item (positive control) was as expected (Animal no BWC2).
- Other effects:
- No abnormal clinical signs were observed during the study.
Bodyweight change: two animals gained weight and one animal lost a small amount of weight.
Any other information on results incl. tables
Table 2: Erythema/eschar and oedema formation after 4 hours exposure
Raisacooat KZ 20 | Erythema and Eschar (score 0-4) | Oedema (score 0-4) | |||||||
Time period (h) | Time period (h) | ||||||||
Rabbit no. | 1 | 24 | 48 | 72 | 1 | 24 | 48 | 72 | Sum |
BWC2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
BWN5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
BWR9 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Sum | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Mean | 0.33 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
1% SDS | Time period (h) | Time period (h) | |||||||
Rabbit no. | 1 | 24 | 48 | 72 | 1 | 24 | 48 | 72 | Sum |
BWC2 | 1 | 2 | 1 | 1 | 0 | 0 | 0 | 0 | 5 |
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 did not elicit any reaction in any of the animals during the course of the study that meant the test material required classification as a skin irritant. The study is considered to be reliable, relevant and adequate for risk assessment and classification and labelling purposes.
- Executive summary:
The skin irritation potential of the test material was determined in accordance with the standardised guidelines OECD 404. The rabbits were each exposed to a dose of 0.5 ml test material for 4 hours and observed for the following 3 days for any sign of skin irritation. A single rabbit was dosed in the same way to a 0.5 ml dose of 1% SDS which acted as a positive control for the test. As expected, there was a positive skin reaction for the reference item. In animals dosed with the test material only animal BWR9 showed very slight erythema 60 minutes after patch removal. The positive skin reaction was reversible within one day. There were no other signs of skin irritation.
Under the conditions of the study, the test material is considered to be practically non-irritating to the skin based on an internal system for description of irritation responses. The test material does not require classification for skin irritation in line with Regulation No 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.