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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
Carcinogenicity
Administrative data
Description of key information
Oral:
NOAEL (rat) = 1760 mg/kg bw/day (RA Syloid 244)
Inhalation:
NOAEC (rat) = 10 mg/m³ (RA Kaolin)
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 1 760 mg/kg bw/day
Carcinogenicity: via inhalation route
Endpoint conclusion
- Dose descriptor:
- NOAEC
- 10 mg/m³
Justification for classification or non-classification
There is no need for classification of Kaolin, calcined as carcinogen.
Additional information
There is no data available for Kaolin, calcined. However, long-term feeding studies are reported for synthetic amorphous silica (SAS) by Takizawa (Takizawa et al. 1988, RL2). Three groups of rats and mice received Syloid 244 at dietary levels of 1.25, 2.5 and 5% for 103 and 93 weeks, respectively. This corresponded to average daily doses of 2000 mg/kg bw/day for the high-dose group of rats and to 4500 to 5800 mg/kg bw/day for the high-dose groups of female and male mice, respectively. The animals were in good condition throughout and showed high survival. The tumour responses in all organs of SAS-treated rats and mice were not statistically significantly different from the controls (Fisher´s exact test and Cochran-Armitage test for trend). Based on the negative results after long-term oral application of SAS, there is no evidence of a carcinogenic potential arising from ingestion of these amorphous minerals.
There is additional data for carcinogenicity which was conducted with the read across substance Kaolin (Wagner, 1987, RL2). None of 40 rats exposed to Kaolin dust at a concentration of 10 mg/m³ for 6 hours per day with exposure durations ranging from 3 months to 12 months showed tumour formation.
Additionally there are several results from epidemiological studies which were also conducted with the read across substance Kaolin supporting the results which were obtained in experimental animals (Altekruse et al. 1984, RL2; Sepulveda et al. 1983, RL2; Kennedy et al., 1983, RL2; Ogle et al. 1989, RL2; Rundle et al., 1993, RL2).
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