Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
DNEL derivation method:
other: The general exposure limit for inhalable inert dust is applied.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
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 inert inhalable dust is applied.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
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:
no hazard identified

Additional information - workers

Based on all the available data, the test substance is not subject to classification and labelling requirements under current EU regulations (Directive 67/548/EEC and Regulation (EC) No.1272/2008).

Systemic effects have been neither observed in acute rodent studies after short-term exposure to the test substance at doses up to 10000 mg/kg bw, nor in an oral combined repeated dose and reproduction / developmental screening study at doses up to 1000 mg/kg bw/d.

The substance is an organic pigment. Based on toxicokinetic considerations (referring to the Chapter R.7 c (2008) of the ECHA guidance on information requirements and chemical safety assessment) and the absence of findings in the oral combined repeated dose and reproduction / developmental screening study, the substance is considered to be not taken up by the body.

The DNEL – systemic effects for long-term exposure can be derived based on the NOAEL from the oral combined repeated dose and reproduction / developmental screening study, set as greater or equal to the highest dose of 1000 mg/kg bw/d (BASF SE, 2013). However, in the absence of effects at the limit dose, a DNEL cannot be sensibly derived and is therefore not provided.

 

Inhalation

As the substance is an inert pigment, local (irritative) effects on the respiratory tract occur if particles of an inhalable size are present at a concentration creating a dust overload situation in the lung. Therefore, the DNEL is set at the general exposure limit for inhalable dust.

 

Dermal

No DNEL is derived because no hazard is identified.

General Population - Hazard via inhalation route

Systemic effects

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

Based on all the available data, the test substance is not subject to classification and labelling requirements under current EU regulations (Directive 67/548/EEC and Regulation (EC) No.1272/2008).

Systemic effects have been neither observed in acute rodent studies after short-term exposure to the test substance at doses up to 5000 mg/kg bw, nor in an oral combined repeated dose and reproduction / developmental screening study at doses up to 1000 mg/kg bw/d.

The substance is an organic pigment. Based on toxicokinetic considerations (referring to the Chapter R.7 c (2008) of the ECHA guidance on information requirements and chemical safety assessment) and the absence of findings in the oral combined repeated dose and reproduction / developmental screening study, the substance is considered to be not taken up by the body.

The DNEL – systemic effects for long-term exposure can be derived based on the NOAEL from the oral combined repeated dose and reproduction / developmental screening study, set as greater or equal to the highest dose of 1000 mg/kg bw/d (BASF SE, 2013). However, in the absence of effects at the limit dose, a DNEL cannot be sensibly derived and is therefore not provided.

 

Inhalation

As the substance is an inert pigment, local (irritative) effects on the respiratory tract occur if particles of an inhalable size are present at a concentration creating a dust overload situation in the lung. The general population does not handle the pigment in its dusty form. Therefore, no DNEL is derived.

 

Dermal

No DNEL is derived because no hazard is identified.