Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 940-683-0 | CAS number: -
- 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
No acute toxicity studies available. Based on the inherent properites of fatty acids, C18 (saturated and unsaturated) ethyl esters and also taking into account the LD50 > 5000 mg/kg bw and LD50 > 2000 mg/kg bw for acute oral and dermal toxicity, respectively for the read-across substance CAS No 67762-38-3 (see attached waiving and justification document in section 13), fatty acids, C18 (saturated and unsaturated) ethyl esters seems to be of low oral and dermal toxicity. The inhalational exposure route is not relevant.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for selection of acute toxicity – oral endpoint
Fatty acids, C18 (saturated and unsaturated) ethyl esters consists primarily of ethyl esters of saturated and unsaturated C18-fatty acids, all of which is considered to be of low acute oral toxicity. In general, hydrolysis results in fatty acids and alcohols (ethanol), te ethanol being biotransformed into the corresponding acids (and acetic acid). The fatty acids are virtually without toxic effect. Fatty acids extracted from natural sources are included in REACH Annex V, point 9 and thus are excluded from registration in accordance with REACH Article 2(7)(b). Taken together, fatty acids, C18 (saturated and unsaturated) ethyl esters and the hydrolysis products seems to be of low oral toxicity, also seen from the read-cross substance used for this registration (CAS No 67762-38-3), where a LD50 > 5000 mg/kg bw was established. Thus, testing for acute oral toxicity seems scientifically unjustified.
Justification for selection of acute toxicity – inhalation endpoint
Fatty acids, C18 (saturated and unsaturated) ethyl esters) has very low vapor pressure and melting point. The potential for generation of inhalable forms is evaluated to be low. Also, the use of fatty acids, C18 (saturated and unsaturated) ethyl esters) will not result in generation of aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur. Thus, testing for acute inhalational toxicity seems scientifically unjustified.
Justification for selection of acute toxicity – dermal endpoint
Fatty acids, C18 (saturated and unsaturated) ethyl esters consists primarily of ethyl esters of saturated and unsaturated C18-fatty acids, all of which is considered to be of low acute oral toxicity. Topically applied fatty acid ethyl esters can penetrate to the living cells of normal epidermis, enter into metabolism and significantly modify endogenous epidermal lipids. In general, hydrolysis results in fatty acids and alcohols (ethanol), te ethanol being biotransformed into the corresponding acids (and acetic acid). The fatty acids are virtually without toxic effect. Fatty acids extracted from natural sources are included in REACH Annex V, point 9 and thus are excluded from registration in accordance with REACH Article 2(7)(b). Taken together, fatty acids, C18 (saturated and unsaturated) ethyl esters and the hydrolysis products seems to be of low oral toxicity, also seen from the read-cross substance used for this registration (CAS No 67762-38-3), where a LD50 > 2000 mg/kg bw was established. Thus, testing for acute dermal toxicity seems scientifically unjustified.
Justification for classification or non-classification
From the available data on acute toxicity for the read-across substance CAS No 67762 -38 -3 (see attached waiving and justification document in section 13), no classification apply for Fatty acids, C18 (saturated and unsaturated) ethyl esters).
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.