Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

Neither TiCl4 nor its hydrolysis products TiO2 and HCl present a potential for 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

Due to rapid hydrolysis of TiCl4 in contact with water the hydrolysis products TiO2 and HCl 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.

Chloride is an essential ion, taken up in large amounts with food and water. HCl is produced in concentrations of up to 0.17 M in the human stomach. Additional uptake of chloride by exposure to HCl stemming from TiCl4, which is limited by the corrosive action of the substance, is negligible compared to this nutritional uptake. In water HCl dissociate into the ions hydrogen and chloride which are essential for and highly abundant in any living organism. The corrosive action of HCl is nullified by the buffering capacities of blood and other tissues. Therefore no hazard is to be expected for the progeny of mammals from HCL stemming from TiCl4 exposure.

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 HCl REACH dossier:

“Hydrochloric acid is irritant or corrosive, depending on concentration, and its toxicity is related to site-of-contact effects. In contact with water it dissociates completely to give eventually hydronium and chloride ions, both normal constituents in the body of all mammalian species, and no systemic toxicity is expected.”

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 these informations TiCl4 is deemed not to have any potential to cause developmental toxicity, teratogenicity or effects on fertility. Therefore further testing is scientifically unjustified.

No classification for the respective endpoints is needed.

Short description of key information:

Neither TiCl4 nor its hydrolysis products TiO2 and HCl present a reproductive toxicity hazard.

Effects on developmental toxicity

Description of key information

Neither TiCl4 nor its hydrolysis products TiO2 and HCl present a potential for developmental toxicity/teratogenicity.

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
Additional information

See discussion above (Effects on fertility).

Justification for classification or non-classification

There is no evidence to suggest that titanium tetrachloride should be classified for reproductive or developmental toxicity.

Additional information