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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 273-727-6 | CAS number: 69012-27-7 By-product of chromium refining containing oxides of aluminum, magnesium and silicon.
- 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
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- repeated dose toxicity: inhalation
- Remarks:
- other: evaluation of an authoritative institution
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Evaluation of an authoritative institution
Data source
Reference
- Reference Type:
- other: Evaluation report
- Title:
- Unnamed
- Year:
- 2 007
Materials and methods
Test guideline
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- The Health Council of the Netherlands evaluation by for health based occupational exposure limit
- GLP compliance:
- no
Test material
- Reference substance name:
- Kaolin
- IUPAC Name:
- Kaolin
- Reference substance name:
- Kaolin
- EC Number:
- 310-194-1
- EC Name:
- Kaolin
- Cas Number:
- 1332-58-7
- IUPAC Name:
- 1332-58-7
- Details on test material:
- Kaolin (CAS number 1332-58-7; EEC number 310-127-6; RTECS number GF1670500) is a clay that consists primarily of kaolinite (CAS number 1318-74-7; EEC number 215-286-4), a non-fibrous aluminium silicate with the molecular formula Al2O3⋅2SiO2⋅2H2O. Kaolin is a fine white to light-yellow powder with an earthy taste.3 It usually contains small amounts of other minerals such as quartz, mica and TiO2. The amounts differ depending on the geographic location at which the kaolin is extracted.
Constituent 1
Constituent 2
Test animals
- Species:
- other: several
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- other: Evaluation of an authoritative institution
- Details on inhalation exposure:
- Review
Results and discussion
Results of examinations
- Details on results:
- The occupational exposure to kaolin has adverse health effects involving the lungs and with pneumoconiosis as the clinical finding.
The occupational exposure to 2.1 mg/m3 respirable kaolin dust constitutes an substantial risk for the development of pneumoconiosis ILO category 1. However, no studies are available from which to establish a NOAEL or LOAEL for kaolin dust.
Effect levels
- Dose descriptor:
- NOAEC
- Remarks on result:
- not determinable
- Remarks:
- no NOAEC identified
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Many reports of well-studied cases and a number of cross-sectional studies have shown that long-term exposure to kaolin may lead to pneumoconiosis, which has been named kaolinosis. Pneumoconiosis is diagnosed by chest X-ray, and is categorized as simple pneumoconiosis (category 1-3) or complicated pneumoconiosis (category A-C). Clinical symptoms and effects on pulmonary function are mainly observed in the complicated form. Although the mildest form of pneumoconiosis ILO category 1 is not yet associated with a decrease of pulmonary function, the pneumoconiosis category 1 can be considered as an undesired health effect, in
agreement with the European Committee’s report on miner’s pneumoconiosis. Studies with exposure data or dose-effect relationships are scarce. The available animal data are not suitable for the derivation of a health-based recommended
occupational exposure limit.
Adequate studies on the carcinogenicity or reproduction toxicity of kaolin are not available.
There is one study with human data in which a dose-response relationship was reported for respirable kaolin dust. According to this study, the average nonsmoking worker reaches pneumoconiosis ILO category 1 at the age of 60 after 40 years of occupational exposure to 2.1 mg/m3 respirable kaolin dust. From the data as presented in this publication, the committee can not establish a NOAEL or LOAEL. The publication does not contain information on the quartz content of the respirable dust exposures, the presence of which in kaolin can make it difficult to distinguish kaolinosis from silicosis (pneumoconiosis caused by quartz).
Applicant's summary and conclusion
- Conclusions:
- The exposure to kaolin has adverse effects involving the lungs and with pneumoconioisis as the clinical finding. However, no studies are available from which to establish a NOAEL or LOAEL for kaolin dust.
- Executive summary:
The available data on repeated dose toxicity caused by kaolin was evaluated by DECOS (2007). The available animal data are not suitable for the derivation of a health-based recommended occupational exposure limit.
There is one study with human data in which a dose-response relationship was reported for respirable kaolin dust.2 According to this study, the average nonsmoking worker reaches pneumoconiosis ILO category 1 at the age of 60 after 40 years of occupational exposure to 2.1 mg/m3 respirable kaolin dust. From the data as presented in this publication, the committee can not establish a NOAEL or LOAEL. The publication does not contain information on the quartz content of the respirable dust exposures, the presence of which in kaolin can make it difficult to distinguish kaolinosis from silicosis (pneumoconiosis caused by quartz).
The occupational exposure to kaolin has adverse health effects involving the lungs and with pneumoconiosis as the clinical finding.
However, no studies are available from which to establish a NOAEL or LOAEL for kaolin dust.
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.