Registration Dossier
Registration Dossier
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EC number: 278-388-8 | CAS number: 76199-85-4
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
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.
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 36888-99-0
were negative. Test article-related systemic effects were also not reported in the reproductive screening (oral gavage) study of the analogous test substance CAS 36888-99-0. Thus, a DNEL – systemic effects for long-term exposure is 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. Since no adverse effects are observed at the limit dose and skin permeability is not expected, no DNEL for dermal exposure is given.
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.
This value is lower than a DNEL that could be derived of a NOAEL of 1000 mg/kg bw of a subacute study.
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
It is referred to the discussion for workers in the section above.
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.
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.
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