Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Extensive testing and reviews have been conducted on titanium dioxide, triethanolamine and propylene glycol, demonstrating that there is no mutagenic potential. 

 

An IARC monograph on triethanolamine suggests that there is no evidence for mutagenicity, and this is cited in the IUCLID file. WORLD HEALTH ORGANIZATION

INTERNATIONAL AGENCY FOR RESEARCH ON CANCER, IARC Monographs on the Evaluation of Carcinogenic Risks to Humans Volume 77

Some Industrial Chemicalshttp://monographs.iarc.fr/ENG/Monographs/vol77/volume77.pdf

 

Titanium dioxide has been extensively investigated, especially in nano-form for use in cosmetics and several review documents suggest low risk. One citation is in Drug Chemistry and Toxicology, 2011 July 34(3):277-84.Cytotoxicity and genotoxicity of titanium dioxide nanoparticles in UVA-irradiated normal peripheral blood lymphocytes: Kang, Lee et al.

Propylene glycol has also been extensively evaluated and review documents suggest low risk of mutagenic potential. A review by the US EPA (Prevention Pesticides and Toxic Substances, EPA-739-R-06-002, September 2006)

 

http://www.epa.gov/oppsrrd1/REDs/propylene_glycol_red.pdf

 

Propylene glycol and dipropylene glycol were tested for mutagenic or genotoxic potential and found to be negative in a battery of studies: a bacterial gene mutation assay using Salmonella typhimurium, and in vitro Chinese hamster ovary (CHO) mutation assay, an in vitro Chinese hamster ovary (CHO) chromosomal aberration assay and an in vitro sister chromatid exchange assay.

 

Propan-2-ol is reported in a review by the EU Scientific Committee on Health and Environmental Risks conclude low toxic risk (25th plenary on 9 September 2008), but suggests that data is limited with regard to in-vitro mutagenicity evaluation.


Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification