Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Based on the weight of evidence from available long-term toxicity studies in rodents and the relevant information on the toxicokinetic behavior in rats it is concluded that TIN, based on data from the read across partner TiO2, does not present a reproductive toxicity hazard. There is evidence from the animal long-term toxicity studies in rats and mice that the intake of high amounts of TiO2 or inhalation to high concentrations of TiO2 was not associated with adverse effects on the reproductive organs. The results of the toxicokinetic study prove that no significant systemic absorption occurred via the oral exposure route as indicated by the titanium concentrations in whole-blood and urine which were below the limit of quantification (<0.04 mg/l). Tissue titanium concentrations in liver, kidney and muscle were below the limit of detection (<0.1- <0.2 mg/kg wet weight) indicating no substantial accumulation of titanium in the body. Furthermore, any metabolism of the inorganic material can be excluded.

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

For the reasons presented above, conducting a reprotoxicity screening study would not provide any further insights in the toxicity of TiN and would not comply with the 3R-rules and the principles of animal welfare (in accordance with Annex X, section 8.7, column 2 of regulation (EC) 1907/2006).


Short description of key information:
Based on the weight of evidence from the available long-term toxicity/carcinogenicity studies in rodents and the relevant information on the toxicokinetic behaviour in rats it is concluded that TiN, based on data from the read across partner TiO2, does not present a reproductive toxicity hazard.

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

Additional information