Registration Dossier
Registration Dossier
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EC number: 627-025-5 | CAS number: 101541-04-2
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Oral acute toxicity tests were performed on analogues substances (lipoaminoacids)
Additional information
Palmitoyl isoleucine must not be classified dangerous according to its acute oral toxicity in compliance with the European Directive 67/548/EC of dangerous substances.
For this evaluation of acute oral toxicity, LD50 –lethal dose 50- has been estimated higher than 2000 mg/kg.
This estimation is based on 2 criteria:
(1) The chemical structure of the product, lipoaminoacid structure, and the raw materials: a fatty acid, palmitic acid, obtained from vegetable oil, and an essential aminoacid, isoleucine.
According to the CIR of 1987 (re-assessed in 2006) on five fatty acids including palmitic acid and to the RTECs data, there is no concern on the acute oral toxicity of palmitic acid; a LD50 above 10g/kg was determined after an administration of doses up to 10 g/kg of palmitic acid by gavage to rabbits.
According to the CIR of 2011 on the alpha-aminoacids used in cosmetics (including isoleucine), isoleucine is not considered to pose any significant safety concern following oral exposure because amino acids are present in all living organisms. The “L-“amino acids are considered Generally Recognized As Safe (GRAS) in direct food additives by the FDA. Furthermore, a LD50 of 6822 mg/kg from the RTECs database was given after an oral administration of isoleucine to rats.
(2) The chemical analogy with other lipoaminoacids, with palmitic fatty chain, for which an acute oral toxicity test has been performed on animal. Especially, TIMECODETM, palmitoyl glycine, and SEPILIFT DPHPTM, dipalmitoylhydroxyproline. Both substances have a LD50 higher than 2000 mg/kg.
Justification for classification or non-classification
Palmitoyl isoleucine must not be classified dangerous according to its acute oral toxicity in compliance with CLP regulation 1272/2008
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