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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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
Key value for chemical safety assessment
Effects on fertility
Additional information
There are no data available for Kaolin, calcined. However, some data are available for structurally related compounds. Sodium silicoaluminate and Syloid 244 were examined for embryotoxic and developmental effects during the gestation phase in various animals species (rat, mouse, rabbit and hamster) at an oral dose of 1600 mg/kg bw/day (Syloid 244: up to 1340 mg/kg bw/day in rats and mice, respectively).
There were no significant signs of maternal or embryotoxic/developmental effects. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the frequencies occuring spontaneously in the control animals (Food and Drug Research Laboratories, 1973).Short description of key information:
No data available.
Effects on developmental toxicity
Description of key information
Oral:
RA from Synthetic silica sodium silicoaluminate:
NOAEL (maternal toxicity): 1600 mg/kg bw/day (for rat, mouse, rabbit and hamster)
NOAEL (teratogenicity): 1600 mg/kg bw/day (for rat, mouse, rabbit and hamster)
RA from Syloid 244 (Silica aerogel):
NOAEL (maternal toxicity): 1340 mg/kg bw/day (for rat and mouse)
NOAEL (teratogenicity): 1340 mg/kg bw/day (for rat and mouse)
NOAEL (maternal toxicity): 1600 mg/kg bw/day (for rabbit and hamster)
NOAEL (teratogenicity): 1600 mg/kg bw/day (for rabbit and hamster)
Effect on developmental toxicity: via oral route
- Dose descriptor:
- NOAEL
- 1 600 mg/kg bw/day
Additional information
There are no data available for Kaolin, calcined regarding developmental toxicity/teratogenicity. However, there are data available for structural analogue substances.
Within the scope of a comprehensive and valid testing programme, sodium silicoaluminate was examined for embryotoxic and developmental effects during the gestation phase in various animals species (rat, mouse, rabbit and hamster) at an oral dose of 1600 mg/kg bw/day. There were no significant signs of maternal or embryotoxic/developmental effects. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the frequencies occuring spontaneously in the control animals (Food and Drug Research Laboratories, 1973).
The administration of up to 1340 mg Syloid 244/kg bw/day to pregnant mice and rats for 10 consecutive days had no clearly discernible effect on nidation or on maternal or fetal survival.
The results of Syloid 244 look similar to the results of silicoaluminate. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls. Syloid 244 was tested up to 1600 mg/kg bw/day in rabit and hamster. Under the experimental conditions Syloid 244 showed no significant effects on teratogenicity in (Food and Drug Research Laboratories, 1973).
An additional study determined the effects of kaolin (clay) ingestion on the maternal blood and embryonic development of the pregnant rat (Patterson and Staszak, 1977, RL2). Thirty-six Sprague-dawley female rats were divided into three groups: control diet, 20% kaolin diet, and iron-supplemented 20% kaolin diet. The diets were fed 37 to 68 days, 69 to 95 days, and 96 to 117 days prior to fertilization, and the same diets were fed for the duration of the gestation period. Results of analysis of variance indicates that the kaolin fed rats did produce pups weighing significantly less than pups born to the controls or the iron-supplemented kaolin fed group. The length of the pups was not significantly different among the three groups across time and no morphological abnormalities were observed in any of the pups.
In another study examining reproductive effects Sprague-Dawley rats were administered calcium montmorillonite orally on pregnancy days 1-15 (Wiles et al., 2004, RL2). No effects were examined on the maternal body weights, litter weights or embryonic resorptions. Detailed examination of fetuses for malformations was not performed; dams were killed to early (on gestational day 16).
Justification for classification or non-classification
Based on data for structurally related compounds it is not expected that Kaolin, calcined produces adverse effects on the reproductive performance or embryonic/foetal development. No classification is required according to DSD (67/548/EEC) or CLP (1272/2008/EC).
Additional information
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.