Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
DNEL (Derived No Effect Level)
Value:
3 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
other: German MAK value for inert inhalable dusts
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:
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).

No systemic effects have been observed in acute rodent studies after short-term and subacute exposure to the test substance in doses up to 2000 mg/kg bw. . Thus, according to Chapter R.8 of the ECHA guidance on information requirements and chemical safety assessment (2008) the systemic DNELs derived for long-term exposure were considered sufficient to ensure the safety of human workers.

The substance is in organic pigment. Based on toxicokinetic considerations and absence of findings in the subacute oral toxicity study and in the screening study for reproductive toxicity, the substance is considered to be not taken up by the body.

Inhalation

The described NOAEL of the oral study has to be modified to get the correct starting point for DNEL derivation for the inhalation route. Here, the NOAEL has to be divided by a factor of 0.38 m3/kg bw and corrected for activity driven differences of respiratory volumes in workers compared to workers in rest (6.7 m3/10 m3)), resulting in a corrected starting point of 1763.2 mg/m3/d. The AF for remaining differences was set as 2.5. In order to recognize possible intraspecies differences in workers an AF of 5 and for time extrapolation (sub-acute to chronic) an AF of 6 was estimated to be appropriate to ensure safety (ECETOC TR 86, 2003) resulting in a total AF of 75 and in a DNEL value of 23.51 mg/m3. It should be noted that the general exposure limit for inhalable dust applies and that the calculated DNEL is higher than any national exposure levels for dust.

General Population - 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:
other toxicological threshold
Value:
3 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
other: German MAK Threshold for inert inhalable dust
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
Modified dose descriptor starting point:
NOAEL
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
Most sensitive endpoint:
repeated dose toxicity
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).

No systemic effects have been observed in acute rodent studies after short-term exposure to the test substance in doses up to 2000 mg/kg bw. Thus, according to Chapter R.8 of the ECHA guidance on information requirements and chemical safety assessment (2008) the systemic DNELs derived for long-term exposure were considered sufficient to ensure the safety of the general population.

Test article-related systemic effects were also not reported in a subacute oral gavage study in rats.