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EC number: 296-473-8 | CAS number: 92704-41-1 The product of high temperature calcination (above 450°C (842°F)) of naturally occurring kaolin, a hydrated aluminum silicate, resulting in the evolution of water and the formation of new substances depending upon the calcination temperatures employed.
- 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
Skin:
Not irritating to skin (RA Kaolin clay polydimethylsiloxane; rabbit, semiocclusive 4 h)
Eye:
Not irritating to eye (RA Kaolin; rabbit, 0.1 mL)
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin irritation
There is only a short abstract available for the skin irritating potential of Kaolin, calcined (KPC Europe 2005, RL4). Therefore read-across was conducted from the structurally related substances Kaolin clay polydimethylsiloxane, silicic acid, aluminium salt (in vitro test) and the FCC catalysts CCZ-44 and FCC CBZ-1 (catalysts contain up to 45% Kaolin, calcined).
In vivo
In an acute skin irritation/corrosion test with three New Zealand White rabbits according to GLP-guideline 404 no effects on skin (edema or erythema, respectively) were detected after 4 hours semiocclusive treatment with Kaolin, calcined (KPC Europe, 2005, RL4).
Kaolin clay polydimethylsiloxane was tested for acute dermal irritation/corrosion in a GLP-guideline study according to OECD Guideline 404 (Engelhard Corp., 1997, RL2).
0.5 gram of the test substance, as 50% (w/w) mixture in distilled water was applied semiocclusive in a single dose to the skin of six New Zealand White rabbits for 4 hours. The observation period was terminated at 72 hours instead of 14 days, since no signs for dermal irritation (edema or erythema, respectively) were noted at any reading time point after patch removal. Furthermore, there were no sign of gross toxicity.
The skin irritating potential of the FCC catalysts CCZ-44 and CBZ-1 were determined in a non-GLP study (Calkins and Ward, 1976, RL2). The test substances were applied at 2000 mg/kg bw to the intact skin of 5 rabbits each for 24 hours under occlusive conditions. No signs of erythema or edema were noted at the treatment sites in any animal during the 48 hour observation period.
In vitro
The skin irritation potential of silicic acid, aluminium salt was determined (Paulus, 2010; RL2) according to OECD guideline (Draft proposal for a new guideline. In vitro skin irritation: human skin model test, Dezember, 2007). Approx. 25 mg of the test item were applied to EpiDermTM tissues. After 35 minutes incubation tissues were rinsed and incubated for further 42 hours. The cell viability was measured photometric by dehydrogenase conversion of MTT. No decrease of cell viability was detected compared to the negative control. Under these test conditions the substance has no skin irritation potential.
Eye irritation
Except of one short abstract (KPC Europe 2005, RL4), no data were located for Kaolin, calcined regarding eye irritation/corrosion. Therefore the structurally-related compounds Kaolin and the FCC catalysts CCZ-44 and CBZ-1 (catalysts contain up to 45% Kaolin, calcined) were taken into account.
In vivo
In an acute eye irritation/corrosion test with three New Zealand White rabbits according to GLP-guideline 404, available as short abstract only, an average grade for redness (conjuntivae) of 0.4 was recorded after treatment with Kaolin, calcined (KPC Europe, 2005, RL4). Other ocular reactions could not be detected.
The acute eye irritation of the read-across substance Kaolin was investigated in a GLP-guideline study (EPA OPPTS 870.2400) in rabbits (Engelhard Corp., 2000, RL2). 0.1 mL (0.04-0.05 g) of the test substance was instilled into the right eye of one male and two female New Zealand White strain rabbits (no washout). The left eye, which remarks untreated, served as control. The resulting ocular reaction to the substance was evaluated by the method of Draize 1, 24, 48 and 72 hours after treatment. One hour following test substance installation, all three treated eyes exhibited conjunctivitis. The overall incidence and severity decreased thereafter. By 48 hours all animals were free of ocular irritation. There were no other signs of gross toxicity.
FCC catalysts CCZ-44 and FCC CBZ-1 were tested in eye irritation studies in rabbits according to the guideline of the Department of Transportation, Code of Federal Regulations, Title 49, Part 173 (Calkins and Ward, 1976, RL2). 100 mg of the test substances were instilled into the conjunctival sac of the right eye of six New Zealand White rabbits each without washing off. The untreated eye of the same animal served as control. The FCC catalysts CCZ-44 and CBZ-1 are not considered as ocular irritant since no eye effects were noted up to 72 hours.
Respiratory irritation
No data available.
Justification for classification or non-classification
Based on the results obtained, Kaolin, calcined does not fulfill the criteria to be classified for eye or skin irritation/corrosion according to DSD (67/548/EEC) or CLP (1272/2008/EC).
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