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Diss Factsheets
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EC number: 627-025-5 | CAS number: 101541-04-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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