Registration Dossier

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:
other toxicological threshold
Value:
3 mg/m³
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

No substance specific data on repeated dose toxicity is available for titanium nitride. Due to similar physico-chemical properties, similar transformation/dissolution results and similar in vitro bioaccessibility in synthetic body fluids compared to titanium dioxide, data from TiO2 can be used for read-across.

Available data on repeated inhalation exposure of rats to titanium dioxide, especially those of the 2-year inhalation toxicity/carcinogenicity study, allowed a derivation of NOAEC values for non-neoplastic adverse and neoplastic effects after chronic exposure to pigment grade titanium dioxide. Two-year inhalation exposure in male and female Sprague-Dawley rats to 10, 50, or 250 mg/m³ of titanium dioxide (Lee et al., 1985) resulted in a dose- and time-dependent deposition of titanium dioxide in the lungs leading to a marked impairment of lung clearance. The continued exposure to titanium dioxide within the lungs was associated with a dose-related dust cell accumulation, a foamy macrophage response, type II pneumocyte hyperplasia, alveolar proteinosis, alveolar bronchiolarisation, cholesterol granuloma formation, focal pleurisy and collagenised fibrosis at exposure to 50 and 250 mg/m³ of titanium dioxide. Based on these findings, a NOAEC of 10 mg/m³ was derived for fibrogenic (non-neoplastic) effects in the lung. Another chronic study in mice, rats and hamsters (Bermudez, 2002) indicate that a concentration of 50 mg/m³ already elicits a particle overload in rats. Thus, the LOAEL is considered to be over-conservative for humans. Instead of deriving a long-term DNEL for the inhalation route for TiN the general dust limit of 3 mg/m³ for respirable particles has been applied according to ECHA guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of dose [concentration]-response for human health, chapter R.8.7.1.

For other workplaces where the nature of the aerosols corresponds largely to the definition of the inhalable/respirable fraction, the application of this DNEL warrants an intrinsic conservatism.

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