Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

Due to rapid hydrolysis of TiCl4 in contact with water via target compound titanium oxychloride to the final hydrolysis products TiO2 and HCl, the final hydrolysis products are the relevant potentially toxic species.

The absorbance of TiO2 from the gastro-intestinal tract has been shown to be below the limit of detection in a toxicokinetic study in rats (Landford-Pollard_2003). Similar results are to be expected for absorption via the respiratory route. Therefore the exposure of progeny towards titanium species stemming from TiCl4 exposure is deemed negligible.

As the pH effects resulting from hydrochloric acid are not of relevance for this assessment, the hazard characterisation shall be based on the other final hydrolysis product titanium dioxide.

Based on column 2 of the table given in REACH Annex IX, the study on reproduction toxicity needs not to be conducted if the substance has been proven to have little toxic activity. This is deemed to be the case for titanium dioxide, as demonstrated in the other toxicity sections of the dossier.

This assessment is in line with the assessments of the potential of the two hydrolysis products to cause reproductive toxicity or teratogenicity:

Citation from the TiO2 REACH dossier: “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 TiO2 does not present a reproductive toxicity hazard.” Finally no effects on reproductive organs were detected in a 2 year study in rats with inhalation exposure to TiCl4 concentrations that caused minimal to severe local effects in the lung. Based on this information, neither parent compound TiCl4, nor target compound TiOCl2, nor final hydrolysis products TiO2 and HCl are deemed to have any potential to cause developmental toxicity, teratogenicity or effects on fertility.

Based on this information neither parent compound TiCl4, nor target compound TiOCl2, nor final hydrolysis products TiO2 and HCl are deemed to have any potential to cause developmental toxicity, teratogenicity or effects on fertility. Therefore further testing is scientifically unjustified.


Short description of key information:
The conduct of reproduction toxicity studies direct on the unstable target compound titanium oxychloride is technically not feasible. Read-across with studies on the final hydrolysis products titanium dioxide and hydrochloric acid is being proposed. Conduct of studies is waived as titanium dioxide has been proven to have little toxic activity. Based on the knowledge available, neither parent compound TiCl4, nor target compound TiOCl2, nor final hydrolysis products TiO2 and HCl are deemed to have any potential to cause developmental toxicity, teratogenicity or effects on fertility.

Effects on developmental toxicity

Description of key information
Neither parent compound TiCl4, nor target compound TiOCl2, nor final hydrolysis products TiO2 and HCl are deemed to have any potential to cause developmental toxicity, teratogenicity or effects on fertility. 
Additional information

See discussion above (Effects on fertility).

Justification for classification or non-classification

Neither parent compound TiCl4, nor target compound TiOCl2, nor final hydrolysis products TiO2 and HCl are deemed to have any potential to cause developmental toxicity, teratogenicity or effects on fertility.

Additional information

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