Registration Dossier
Registration Dossier
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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.
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3 mg/m³
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3 mg/m³
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3 mg/m³
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3 mg/m³
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
Workplace exposure to Kaolin, calcined is neither regulated on the EU level nor in any of the member states. Therefore, the limits of inhalation exposure to Kaolin, calcined at the workplace are based on the general limit values for dust (TRGS 900, June 2008):The existing OEL for dust is 3 mg/m³ (alveolar fraction) and 10 mg/m³ (respirable fraction). It is proposed to adopt the more critical value of 3 mg/m³ as DNEL. This approach is in compliance with the ECHA "Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose [concentration]-response for human health", May 2008.
Kaolin, calcined contains respirable quartz (CAS No.14808-60-7) in concentrations below 1%. Cristobalit could not be detected in Kaolin, calcined.
IMA-Europe (2010) proposes to classifiy mixtures and substances containing respirable crystalline silica (respirable quartz and respirable cristobalite, RCS) for the silicosis hazard as STOT RE 1, if the RCS concentration is equal to or greater than 10% and as STOT RE 2, if the RCS concentration is between 1 and 10%. In the case the RCS content in mixtures and substances is below 1%, no classification is required.
Therefore, there is no need for classification of Kaolin, calcined for repeated dose by the inhalative route.
Reference:
IMA, Position Paper (February 2010). Classification and labelling of respirable crystalline silica (RCS). http://www.ima-reach-hub.eu/index.php?option=com_docman&task=cat_view&gid=66
General Population - Hazard via inhalation route
Systemic effects
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
A risk potential to the general population is not expected at all. Since exposure of the general public is not relevant, DNELs for the general population were not derived.
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.
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