Glycerides, C16-22

Endpoint summary

Description of key information

Oral NOAEL for risk assessment purposes: 7.5% in feed, equivalent to an estimated 3,750 mg/kg bw/day.

Dermal exposure is lower than oral due to lower penetration (10 versus up to 17%).

No significant respiratory exposure.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion

Dose descriptor:

NOAEL

3 750 mg/kg bw/day

Study duration:

subchronic

Species:

rat

Justification for classification or non-classification

A large number of repeated dose oral toxicity studies have been conducted with ‘glycerides, C16-22 (SDA Reporting Number: 21-001-00)’ and other substances of the same read-across category. These studies are usually conducted in the form of various vegetable oils at different degrees of hydrogenation, particularly in the context of nutritional research as well as in toxicological investigations. As defined in the present Chemical Safety Report (see Section 1.2), ‘glycerides, C16-22 (SDA Reporting Number: 21-001-00)’ is a component of normal diets.Differences may be observed on bodyweight gain, food consumption and certain measured parameters depending on the nature, chain length distribution of the fatty acids associated to the glycerides and their degree of unsaturation. Similar results were obtained for the other substances of the same read-across category. But overall research indicates that, when consumed at nutritionally relevant concentrations (i.e. typically up to the equivalent of 35% of calories in food), there are no adverse effects on health and longevity. The maximum levels of erucic acid in food, are limited in Europe to10% in oil for human consumption and 5% as total level of fatty acids in the fat component of diets.

Across all studies, tested doses ranged from 7.5 to 19% in diet. No significant toxicity was seen at any of the tested dose rates. For risk assessment purposes, the relevant oral NOAEL could therefore conservatively be considered to be 7.5% in diet (the NOAEL for ‘glycerides, C16-22 (SDA Reporting Number: 21-001-00)’), on the basis of a sub-chronic feeding study, which is equivalent to an estimated 3,750 mg/kg bw/day.

‘Glycerides, C16-22 (SDA Reporting Number: 21-001-00)’ and other substances from the same read-across categorypresent 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.

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,repeated inhalation exposure is not expected to pose an issue for human health.

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