Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Workers - 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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

Inhalation exposure.

Available oral and dermal studies do not indicate any systemic adverse effects. Neither systemic nor local findings were detected. The physicochemical properties support the notion that the test material is not bio-available. Thus, no substance specific adverse effects are to be expected after inhalation exposure. Nevertheless, effects based on the presence of dust in the respiratory tract cannot completely be excluded.

As no inhalation data are available precaution leads to the conclusion of “low hazard”.

Dermal exposure

No hazard identified

Available oral and dermal studies do not indicate any systemic or local adverse effects of treatment. Neither systemic nor local findings were detected. The physicochemical properties support the notion that the test material is not bio-available. Thus, no substance specific adverse effects are to be expected after dermal exposure.

 

Eye exposure

Low hazard (no threshold derived)

The available eye irritation study indicates a slight local irritation of the conjunctivae. The physicochemical properties support the notion that the test material is not bio-available but acts as a solid foreign body. No substance specific adverse effects are to be expected after ocular exposure.

General Population - Hazard via inhalation 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
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

There is no exposure of the general population to the material.