Registration Dossier

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.