Registration Dossier
Registration Dossier
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EC number: 250-097-0 | CAS number: 30233-64-8
Eye irritation
Administrative data
- Endpoint:
- eye 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. - GLP compliance:
- not specified
- Remarks:
- Data extracted from expert opinions
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 eye 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 f experimental animal data from rabbit studies (NZW rabbits) as referenced in CIR (2016).
No eye irritation were seen with undiluted glyceryl behenate and glyceryl palmitate/stearate (not irritating; slight lacrimation in all animals at 1 h and 1 animal at 24 h; no other ocular effects were observed) while undiluted glyceryl rosinate showed slightly eye irritation in two studies (first study: slightly irritating; mild irritation of the conjunctiva was observed in 4 rabbits at 24-h. Second study: slightly irritating; slight signs of irritation to the cornea, iris, and the conjunctiva; conjunctival irritation did not fully reverse in 2 animals within 72 h).
Same lack of clear eye irritation was seen using glyceryl oleate, glyceryl ricinoleate, glyceryl stearate when testing formulations containing 50 -100%. Further, glyceryl citrate/lactate/linoleate/oleate was not classified as ocular irritants in rabbits.
Based on the lack of eye irritation in experimental animal testing with glycerol monobehenate and other esters of glycerol and other fatty acids, the overall weight of evidence indicates that glycerol behenate does not cause eye irritation and should not be classified for eye irritation according to (EC) No 1272/2008.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the lack of eye irritation in experimental animal testing with glycerol behenate and other esters of glycerol and other fatty acids, the overall weight of evidence indicates that glycerol behenate does not cause eye irritation and should not be classified for eye irritation according to (EC) No 1272/2008.
- Executive summary:
Limited data available on eye 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 available information comprises adequate, reliable studies from reference substances with similar structure and intrinsic properties. The weight-of-evidence approach is justified based on common functional group and common precursors/breakdown products. The information from these independent sources is consistent and provides sufficient weight of evidence leading to an endpoint conclusion in accordance with Annex XI, 1.2, of Regulation (EC) No 1907/2006
The eye 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 on eye irritation of glycerol monoesters describes a number of experimental animal data from rabbit studies. No eye irritation were seen with undiluted glyceyl behenate and glyceryl palmitate/stearate while undiluted glyceryl rosinate showed slightly eye irritation. Same lack of clear eye irritation were seen using glyceryl oleate, glyceryl ricinoleate, glyceryl stearate when testing formulations containing 50 -100%. Further, glyceryl citrate/lactate/linoleate/oleate was not classified as ocular irritants in rabbits.
Based on the lack of eye irritation in experimental animal testing with glycerol behenate and other esters of glycerol and other fatty acids, the overall weight of evidence indicates that glycerol behenate does not cause eye irritation and should not be classified for eye 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.
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