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EC number: 250-097-0 | CAS number: 30233-64-8
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- other: Weight of evidence analysis based on expert evaluation data on hydrolysis products and structural analogues
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: based on expert group reviews
- Justification for type of information:
- Because of the structural and functional similarities, data from other glyceryl monoesters are also included in this weight of evidence assessment as supporting data.
The following expert opinion (attached in section 13) will be used in the weight of evidence approach:
CIR 2016: Cosmetic Ingredient Review. Safety assessment of monoglyceryl monoesters as used in cosmetics. Final amended report, January 15, 2016.
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 022
- Report date:
- 2022
Materials and methods
- Principles of method if other than guideline:
- In relation to the data requirements of REACH Annex VIII (10-100 t/y), data on acute toxicity must be provided. Limited data on this endpoint is available for docosanoic acid, monoester with glycerol (glycerol monobehenate).
Glycerol monobehenate is a mono-constituent substance. The main component is docosanoic acid, monoester with glycerol which is present in the product at a concentration of 80-97%; the remaining compounds are mainly fatty acids and monoesters of fatty acid and glycerol. Glycerol can also be present in a low concentration. Glyceryl monoesters (monoglycerides) are metabolized to free fatty acids and glycerol, both of which are available for the resynthesis of triglycerides.
The acute toxicity of this substance is therefore assessed in the present document as a weight of evidence analysis based on existing data on groups of mono-, di- and triglycerides, fatty acids, which are all components with similar properties. Hereby, data is available for deriving a conclusion on the acute toxicity of the substance.
A weight of evidence approach is used for the assessment of the acute toxicity via oral, inhalation, and dermal route of exposure.
Test material
- Reference substance name:
- Docosanoic acid, monoester with glycerol
- EC Number:
- 250-097-0
- EC Name:
- Docosanoic acid, monoester with glycerol
- Cas Number:
- 30233-64-8
- Molecular formula:
- C25H50O4
- IUPAC Name:
- 2-hydroxy-1-(hydroxymethyl)ethyl docosanoate
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST MATERIAL
- Concentration (if solution): - Duration of exposure:
- 24 h
- Doses:
- 5000 mg/kg
- No. of animals per sex per dose:
- 4
Results and discussion
Effect levels
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Collection of relevant data, please see attached document
- Clinical signs:
- other:
Applicant's summary and conclusion
- Conclusions:
- No irritation observed, no acute toxicity at the tested level
- Executive summary:
Glycerol monobehenate is a mono-constituent substance. The main component is docosanoic acid, monoester with glycerol which is present in the product at a concentration of 80-90%; the remaining compounds are mainly fatty acids and monoesters of fatty acid and glycerol. Glycerol can also be present in a low concentration. Glyceryl monoesters (monoglycerides) are metabolized to free fatty acids and glycerol, both of which are available for the resynthesis of triglycerides.
From literature search, no specific data on the acute dermal toxicity of glycerol monobehenate was found. However, three studies conducted on other glycerol monoesters of fatty acids were found in an expert assessment from CIR (2016).
Glyceryl Rosinate was administered to New Zealand white Rabbits at 5000 mg/kg bw or 10 000 mg/kg bw in water. The report LD50 in the two studies were 5000 and 10 000 mg/kg bw.
Glycerides, C16-18 and C18-hydroxy mono- and di- was administered neat on Wistar rats at 2000 mg/kg bw. No irritation was observed and the LD50 was set at 2000 mg/kg bw.
Based on the dermal studies identified in the CIR report, the expert panel concluded that the LD50 for glyceryl rosinate, and glycerides, C16-18 and C18-hydroxy mono- and di- are 10 000 mg/kg bw and 2000 mg/kg bw, respectively.
The overall conclusion is therefore that monobehenate has low acute dermal toxicity with a LD50-value above 2000 mg/kg bw. Thus, classification for acute dermal toxicity according to (EC) No 1272/2008 is not warranted.
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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