Registration Dossier
Registration Dossier
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EC number: 226-971-2 | CAS number: 5580-58-5
Toxicological Summary
Administrative data
Workers - 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
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 substances 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 substances are organic pigments. Based on toxicokinetic considerations (referring to the Chapter R.7 c (2017) 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 substances are 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, 2013). However, in the absence of effects at the limit dose, a DNEL cannot be sensibly derived and is therefore not provided.
Inhalation
No DNEL for systemic effects is derived because no hazard is identified.
Dermal
No DNEL is derived because no hazard is identified.
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
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, Report No. 85R0411/11C114, 2012). 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.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
