Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Oral NOAEL for risk assessment purposes: 18.5% in feed, equivalent to an estimated 9,250 mg/kg bw/day. 
Dermal exposure is lower than oral due to lower penetration (10 versus up to 96%).
No significant respiratory exposure.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
9 250 mg/kg bw/day
Study duration:

Additional information

Justification for classification or non-classification

A large number of repeated dose oral toxicity studies have been conducted with ‘glycerides, C8-18 and C18-unsatd. (SDA Reporting Number: 01-001-00)’ in the form of various vegetable oils at different degrees of hydrogenation in the context of nutritional research as well as in toxicological investigations. As defined in the present regsitration, this substance is a components of normal diets. Although differences may be observed on bodyweight gain, food consumption and certain measured parameters depending on the chain length distribution of the fatty acids associated to the glycerides and their degree of unsaturation, research overall indicates that, when consumed at nutritionally relevant concentrations (i.e. up to the equivalent of ca. 35% of total calorie intake, there are no adverse effects on health and longevity. Similar results were obtained for the other substances of the same read-across category. Across all studies, the highest oral NOAEL could be considered to be 18.5% in feed, equivalent to an estimated9,250mg/kg bw/day. This value is considered relevant for risk assessment purposes, although it is only a reflection of the study setup and not of effects observed at higher doses.

‘Glycerides, C8-18 and C18-unsatd. (SDA Reporting Number: 01-001-00)’ and other substances from the same read-across category present low systemic toxicity upon repeated dose oral exposure for which absorption is higher than via the dermal route, so that repeated dose dermal toxicity is also expected to be minimal. Furthermore, given its physical state (solid to semi-solid under environmental conditions), low vapour pressure and the fact that it is not handled or marketed as a liquid or a powder, repeated inhalation exposure is not considered to pose an issue for human healthunder normal and foreseeable handling and use conditions.

Based on the above information, the substance does not qualify for classification according to Directive 67/548/EC or Regulation 1272/2008/EC.