Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.32 mg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.32 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.032 mg/L
Assessment factor:
500
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 only assess the aquatic toxicity of the degradation products. A review of the components demonstrates that only triethanolamine has any significant toxicity to aquatic organisms and review of data has concentrated on this component.

 

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. 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. 

 

There has been extensive research on titanium dioxide pigments and a review by the US EPA has been used as a source of information (UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES)

 

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

A titanate complex has been extensively tested and data is used as part of the read-across process. This is for the substance Titanium complexes of ammonium lactate, triisopropanolamine and polyethylene glycol, CAS 1072830-14-8. This demonstrates the limited toxicity of this class of substance, even though it is questionably whether aquatic studies should have been attempted for this substance without pre-hydrolysing in accordance with OECD guideline 23 on testing of difficult substances.

Classification is not required.