Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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: 250-097-0 | CAS number: 30233-64-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- other: weight of evidence analysis based on expert evaluated 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:
- Data are available for docosanoic acid, monoester with glycerol as well as similar glycerol monoesters (glyceryl hydrogenated rosinate, glyceryl rosinate, and glyceryl stearate) in relation to skin irritating properties.
The following expert opinions (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 data requirements of REACH Annex VIII (1-10 t/y), data on skin irritation 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, 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 skin irritation potential of this substance is therefore assessed using a weight of evidence approach based on the sparse data on glycerol monobehenate and the group of other monoglycerides with long chain fatty acids, having similar properties. Hereby, a larger data set is available for deriving a conclusion on the skin irritation properties of the substance.
A weight of evidence approach is used for the assessment of the skin irritation potential of the substance.
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
Results and discussion
In vivo
Results
- Remarks on result:
- other: The overall weight of evidence indicates that glycerol monobehenate does not cause skin irritation and should not be classified for skin irritation according to (EC) No 1272/2008.
Any other information on results incl. tables
The attached weight of evidence document describes a number of human data and experimental animal data from rabbit studies (NZW rabbits) as referenced in CIR (2016).
The CIR (2016) expert assessment of glycerol monoesters describes a number of human repeat insult patch tests (RIPT) and single-insult occlusive patch tests with different glycerol monoesters tested at different concentrations (15-50%). These data indicate that glycerol monoesters of fatty acids with chain length of C12 and in a concentration level of 50% may induce irritation on human skin, whereas glycerol esters of fatty acids with chain length at and above C14 in a concentration level up to 50% do not cause skin irritation. From these studies it can be concluded that in humans no indications of dermal irritation were reported in dermal irritation and skin sensitisation testing with esters of glycerol and fatty acids with a chain length of C14 and above.
Further, the CIR (2016) expert assessment also describes experimental animal data on skin irritation. From these, it can be concluded that undiluted glycerol monobehenate, glyceryl hydrogenated rosinate, glyceryl rosinate, and glyceryl stearate were not irritating to rabbit skin when using occlusive patch (NZW rabbits).
The overall weight of evidence indicates that glycerol behenate does not cause skin irritation and should not be classified for skin irritation according to (EC) No 1272/2008.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Undiluted glycerol monobehenate, glyceryl hydrogenated rosinate, glyceryl rosinate, and glyceryl stearate was not irritating to rabbit skin. In humans no indications of dermal irritation were reported in dermal irritation and skin sensitisation testing with esters of glycerol and fatty acids with a chain length of C14 and above. The overall weight of evidence indicates that glycerol behenate does not cause skin irritation and should not be classified for skin irritation according to (EC) No 1272/2008.
- Executive summary:
Limited data available on skin irritation for docosanoic acid, monoester with glycerol (glycerol monobehenate). Glycerol monobehenate is a mono-constituent substance. The main component is docosanoic acid, monoester with glycerol, 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 skin irritation potential of docosanoic acid, monoester with glycerol (glycerol monobehenate) is therefore assessed using a weight of evidence approach based on the sparse data on glycerol monobehenate and the group of other monoglycerides with long chain fatty acids, having similar properties. Hereby, a larger data set is available for deriving a conclusion on the skin irritation properties of the substance.
The CIR (2016) expert assessment of glycerol monoesters describes a number of human repeat insult patch tests (RIPT) and single-insult occlusive patch tests with different glycerol monoesters tested at different concentrations. From these studies it can be concluded that in humans no indications of dermal irritation were reported in dermal irritation and skin sensitisation testing with esters of glycerol and fatty acids with a chain length of C14 and above. Further, the CIR (2016) expert assessment also describes experimental animal data on skin irritation. Form these, it can be concluded that undiluted glycerol monobehenate, glyceryl hydrogenated rosinate, glyceryl rosinate, and glyceryl stearate were not irritating to rabbit skin.
The overall weight of evidence indicates that glycerol monobehenate does not cause skin irritation and should not be classified for skin irritation according to (EC) No 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.
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.
