Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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