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.
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Dose descriptor:
- NOAEL
- 7 000 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
Based on evidence from other substances of the same read-across category,‘glycerides, C16-22 (SDA Reporting Number: 21-001-00)’are not expected to show reproductive/developmental toxicity after oral exposure. No reproductive toxicity is expected from dermal exposure as systemic uptake will be lower than from the oral route.Due to 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 handled in powder form, sprayed or otherwise finely dispersed in the air, the use of respiratory protection (filter mask) is recommended at workplace.Thus, the reproductive toxicity as a result of respiratory exposure is considered unlikely.
Further, ‘glycerides, C16-22 (SDA Reporting Number: 21-001-00)’ and other substances of the same read-across categoryhave 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 reproductive toxicity classification for reproductive or developmental toxicity according to Directive 67/548/EC or Regulation 1272/2008/EC.
Additional information
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