Registration Dossier
Registration Dossier
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EC number: 268-083-8 | CAS number: 68002-70-0 This substance is identified by SDA Substance Name: C16-C22 trialkyl glyceride and SDA Reporting Number: 21-001-00.
Carcinogenicity
Administrative data
Description of key information
Not considered to be carcinogenic.
Key value for chemical safety assessment
Justification for classification or non-classification
Oral carcinogenicity testing was not conducted for ‘glycerides, C16-22 (SDA Reporting Number: 21-001-00)’. However,other substances of the same read-across category,i.e. ‘glycerides, C8-18 and C18-unsatd. (SDA Reporting Number: 01-001-00)’ and ‘glycerides, C16-18 and C18-unsatd. (SDA Reporting Number: 11-001-00)’have been tested for carcinogenicity in rodents and found to have no effects after oral exposure.Results are summarised in the table below.
Moreover, predictions for ‘glycerides, C16-22 (SDA Reporting Number: 21-001-00)’ (considering the major components of fully hydrogenated high erucic acid rapeseed oil, (i.e. tribehenin and tristearin) from the Danish QSAR database and Toxtree (v.1.6) reveal no structural alert for carcinogenicity.
This is in line with the fact that these substances are well known to have a very long history of safe use in nutritional (food and feed), cosmetic and industrial applications.In the form of olive oil, corn oil, sunflower oil, etc., they are also frequently employed as vehicles in toxicity studies following international testing guidelines (e.g. OECD) for the evaluation of the repeated dose toxicity, carcinogenicity or reproductive/developmental toxicity of chemical substances, without any apparent adverse effects (CIR, 1997 and 2001b).
As dermal absorption is lower than absorption via the oral route (see Section 5.7), carcinogenicity following dermal systemic uptake is not expected. This is further supported by negative genotoxic/mutagenic effects.
Finally,based on its physical state (solid) and low vapour pressure (< 1.33 x 10-8Pa at 20°C), the possibility of inhalation exposure will be extremely limited. In many cases the substance is used in industrial applications and transported and handled in liquid form (heated). If the substance is in powder form, sprayed or otherwise finely dispersed in the air, the use of respiratory protection (filter mask) is recommended at workplace. Thus carcinogenicity as a result of respiratory exposure is considered unlikely.
Additional information
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