Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Route of original study:
Oral
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
other: The general exposure limit for inhalable dust is applied. A specific DNEL for local effects was not determined as no relevant hazard was identified in the available data set (according to 67/548/EEC and EC/1272/2008).
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Route of original study:
Oral
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

The substance was found to be inert and overall poorly soluble.This is consistent with its function as a pigment. As such, its hazard is restricted to the dusty form which contains particles in the inhalable size range. Inert particles are cleared from the lung unless an overload burden is reached. The most sensitive endpoint would be general lung toxicity, which is not available from the picklist. Instead the respiratory tract (irritation) was chosen and the general inhalable dust limit of 3 mg/m3 air is given as the DNEL for long-term local effects.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Route of original study:
Oral
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

The substance was found to be inert and overall poorly soluble.This is consistent with its function as a pigment. As such, its hazard is restricted to the dusty form which contains particles in the inhalable size range. The pure, dusty product is neither intended for use by the general population nor are there any possible use scenarios that might be of interest to the general population. The pigments are contained in coatings of articles and are embedded in a matrix. Based on the very low vapour pressure, evaporation from the matrix is not possible. Therefore, no DNELs for the general population need to be derived.