Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Dose descriptor:
NOAEL
7 500 mg/kg bw/day
Additional information
Short description of key information:
No reproductive toxicity

Effects on developmental toxicity

Description of key information
No developmental toxicity
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
7 500 mg/kg bw/day

Justification for classification or non-classification

‘Glycerides, C8-18 and C18-unsatd. (SDA Reporting Number: 01-001-00)’ and other substances of the same read-across category have been tested for reproductive toxicity in rodents and found to have no effect after oral exposure. No reproductive toxicity is expected from dermal exposure as systemic uptake will be lower than from the oral route. Finally, given the physical state, low vapour pressure of the substance and the fact that it is not handled or marketed as a liquid or a powder, reproductive toxicity as a result of inhalatory exposure is not expected.

 ‘Glycerides, C8-18 and C18-unsatd. (SDA Reporting Number: 01-001-00)’ and other substances of the same read-across category 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.

Based on the existing information, the substance does not require classification for reproductive or developmental toxicity according to Directive 67/548/EC or Regulation 1272/2008/EC.

Additional information