Registration Dossier

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Administrative data

Description of key information

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Extensive testing and reviews have been conducted on titanium dioxide, triethanolamine and propylene glycol, demonstrating limited adverse effects over repeat application. Propan-2-ol vapour may cause some adverse effects at very high levels, but it is not considered likely that even under condition of rapid degradation in water, propan-2-ol vapour will form due to the high water solubility of the alcohol.

 

Propan-2-ol NOAEL 1000 mg/kg/day, but with slight liver weight increase. This is reported as part of a reproduction toxicity assay. Review by the EU Scientific Committee on Health and Environmental Risks conclude low toxic risk (25th plenary on 9 September 2008)

 

http://ec.europa.eu/health/archive/ph_risk/committees/04_scher/docs/scher_o_105.pdf

 

Triethanolamine, NOAEL 1000 mg/kg/day over 90 days (Disseminated dossier, Source: European Chemicals Agency,http://echa.europa.eu/)

Titanium complexes of ammonium lactate, triisopropanolamine and polyethylene glycol is included as a supporting study, with only a slight change in blood parameters that were not considered to be adverse.

 

90 day inhalation,Propan-2-ol Regul Toxicol Pharmacol.1996 Jun; 23(3):183-92. Isopropanol: summary of TSCA test rule studies and relevance to hazard identification. Kapp RW JR et al) the study result was to be NOAEL 5000 ppm

Justification for classification or non-classification

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