Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.32 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.032 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
no hazard identified

Sediment (freshwater)

Hazard assessment conclusion:
no hazard identified

Sediment (marine water)

Hazard assessment conclusion:
no hazard identified

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
no hazard identified

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Due to the degradation when mixed in water, it is considered valid to assess the chronic aquatic toxicity of the degradation products. A review of the components demonstrates that only the amine has any significant toxicity to aquatic organisms and review of data on this component suggest low toxicity. The data provided from the NONS assessment suggests a higher level of toxicity to Daphnia than estimated and it is possible that the TiO2 precipitate cause physical harm to the Daphnia.

A PNEC has been set using the triethanolamine component, present in molar ratio at < 50% w/w in the substance. Limited chronic aquatic toxicity has been found, but one reference noted that suggests Daphnia reproductive effect at 16 mg/l for triethanolamine (equivalent to 32 mg/l for the registered substance). This study has also been cited in the disseminated dossier for triethanolamine (Source: European Chemicals Agency,http://echa.europa.eu/) and has been used to set a PNEC of 32 mg/l.

 

 

PNEC estimates for propan-2-ol is estimated and propylene glycol are reported at over 100 mg/l, so these are not considered to be contributing to any hazard from the substance. Source: European Chemicals Agency,http://echa.europa.eu/. These have not been reviewed in detail. 

 

The reported NOEC for Daphnia over 21 days is 2 mg/l based on titanium analysis, but this is not considered valid.

Instead, published long-term toxicity of diethanolamine is used, together with the default assessment factors

Titanium is considered to be a poor indictor from analysis and it is itself shown to be of low hazard.

http://www.epa.gov/opprd001/inerts/titaniumdioxide.pdf

 

β€œThe available ecotoxicity data on titanium dioxide are primarily limited to acute aquatic toxicity studies. The acute aquatic LC,, of titanium dioxide in is reported to be >I000 mg/L based on water accommodated fraction (ECOTOX 2002). Based on the insoluble nature of titanium dioxide in water and the low acute toxicity of titanium dioxide to freshwater fish, there are no non-target aquatic species risk concerns resulting from the use of titanium dioxide as an inert ingredient. Based on the lack of absorption as well as no identified toxicological effects of concern in animal testing, there are also no risk concerns for non-target terrestrial organisms resulting from the use of titanium dioxide as an inert ingredient.”

Conclusion on classification

Acute toxicity indicates that classification is not required.