Registration Dossier

Diss Factsheets

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:
DNEL (Derived No Effect Level)
Value:
3 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
other: General exposure limit for inhalable inert dust
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
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 item is not subject to classification and labeling requirements under current EU regulations (Directive 67/548/EEC and Regulation (EC) No.1272/2008.

No systemic effects have been observed in rodent studies after short-term and long-term exposure to the test substance. The LD50 for acute oral exposure is greater than 10000 mg/kg bw. For acute dermal exposure the LD50 is greater than 2500 mg/kg bw. Thus, according to Chapter R.8 of the ECHA guidance on information requirements and chemical safety assessment (2008) the DNEL derived for long-term exposure was considered sufficient to ensure the safety of human workers.

The test substance is not irritating to skin and eyes and has no skin sensitizing potential. All in vitro and in vivo genetic toxicity studies with the test substance and the analogous test substance CAS 76199-85-4 were negative. Test article-related systemic effects were also not reported in the subacute oral gavage study of the analogous test substance CAS 76199-85-4. Thus, DNEL – systemic effects for long-term exposure are not required.

The overall assessment factor of 600 applied to the NOAEL of 1000 mg/kg bw/d results in a theoretical DNEL (dermal) for workers of > 1.67 mg/kg bw/d. However, since no adverse effects were seen at the limit dose and skin permeability is not expected, no DNEL for dermal exposure is provided.

 

In addition, the NOAEL was modified to get the correct starting point for DNEL derivation for the inhalation route (route to route extrapolation, oral to inhalation), resulting in a corrected starting point of 1763.2 mg/m3/d (division by factor 0.38 m3/kg bw; corrected for activity driven differences of respiratory volumes in workers compared to workers in rest (6.7 m3/10 m3)). 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 and the AF for the quality of the whole database (for the read-across substance) was set as 2 to be appropriate to ensure safety (ECHA, 2008) resulting in a DNEL (inhalation) value of 11.75 mg/m3.  

For local long-term inhalation toxicity, it needs to be considered that the substance is handled in a dusty form. In order to protect against local overload from dust exposure, the general exposure limit for inhalable dust of 3 mg/m3is applied. As this value is lower than the one for long-term inhalation systemic effects, only the local DNEL (general inhalable dust limit) is displayed.

  ECHA (2008): Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterization of dose [concentration]-response for human health.

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 labeling requirements under current EU regulations (Directive 67/548/EEC and Regulation (EC) No.1272/2008).

No systemic effects have been observed in rodent studies after short-term and long-term exposure to the test item. The LD50 for acute oral exposure is greater than 10000 mg/kg bw. For acute dermal exposure the LD50 is greater than 2500 mg/kg bw.

The test substance is not irritating to skin and eyes and has no skin sensitizing potential. Two in vitro genetic toxicity studies were negative. Test article-related systemic effects were also not reported in the subacute oral gavage study of the analogous test substance CAS 76199-85-4.

 

No DNEL is derived for inhalation by consumers because the pigment is present in consumer products in a not inhalable form. It is always embedded in a matrix.

 

A DNEL for long-term oral exposure is not provided because no adverse effects were observed at the limit dose.

 ECHA (2008): Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose [concentration]-response for human health.