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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/carcinogenicity studies in rodents and the relevant information on the toxicokinetic behavior in rats it is concluded that TiO2 does not present a reproductive toxicity hazard. There is evidence from the animal long-term toxicity/carcinogenicity 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 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 carbide. 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 can be used for read-across.

For the reasons presented above, conducting a developmental toxicity study and two-generation reproduction toxicity study would not provide any further insights in the toxicity of TiC. Because of the lack of absorption and systemic distribution an exposure of the reproductive organs in male and female rats to TiC is rather unlikely. Thus any specific effects on reproduction are not to be expected. Therefore, it is scientifically not justified to conduct a developmental toxicity study and two-generation reproduction study in rats which complies 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:
no substance specific data available

Justification for classification or non-classification