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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 215-549-3 | CAS number: 1330-80-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data is from peer reviewed journals
Data source
Reference
- Reference Type:
- publication
- Title:
- Safety Assessment of Propylene Glycol Esters as Used in Cosmetics
- Author:
- Lillian C. Becker
- Year:
- 2 014
- Bibliographic source:
- Cosmetic Ingredient Review Washington, DC, August 18, 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- A skin irritation study was conducted on male albino rabbits to assess the irritation potential of Propylene glycol oleate.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2-hydroxypropyl octadec-9-enoate
- Cas Number:
- 1330-80-9
- Molecular formula:
- C21H40O3
- IUPAC Name:
- 2-hydroxypropyl octadec-9-enoate
- Test material form:
- liquid
- Details on test material:
- - Name of test material : 2-hydroxypropyl octadec-9-enoate
- Molecular formula: C21H40O3
- Molecular weight : 340.544 g/mol
- Smiles notation : C(CC(OC[C@@H](C)O)=O)CCCCC\C=C\CCCCCCCC
- InChl : 1S/C21H40O3/c1-3-4-5-6-7-8-9-10-11-12-13-14-15-16-17-18-21(23)24-19-20(2)22/h10-11,20,22H,3-9,12-19H2,1-2H3/b11-10+
- Substance type:Organic
- Physical state:Liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material: 2-hydroxypropyl octadec-9-enoate
- Molecular formula: C21H40O3
- Molecular weight: 340.544 g/mol
- Smiles notation: C(CC(OC[C@@H](C)O)=O)CCCCC\C=C\CCCCCCCC
- InChl : 1S/C21H40O3/c1-3-4-5-6-7-8-9-10-11-12-13-14-15-16-17-18-21(23)24-19-20(2)22/h10-11,20,22H,3-9,12-19H2,1-2H3/b11-10+
- Substance type: Organic
- Physical state: Liquid
Test animals
- Species:
- rabbit
- Strain:
- other: albino
- Details on test animals or test system and environmental conditions:
- sex: male
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- other: tetraglycol:distilled water 1:1, with and without 1% lidocaine
- Controls:
- not specified
- Amount / concentration applied:
- 1% in tetraglycol:distilled water 1:1, with and without 1% lidocaine
- Duration of treatment / exposure:
- Day 1, 3, 5, and 7
- Observation period:
- The test sites were kept under occlusion except when the dressing was removed on days 1, 3, 5, and 7 only long enough for observation
- Number of animals:
- 3 male albino rabbits
- Details on study design:
- Details on study design
TEST SITE
- Area of exposure: backs (clipped of hair) of the rabbits
- % coverage: exposure area diameter of 1.5 cm2
- Type of wrap if used: adhesive plasters
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data available
- Time after start of exposure: No data available
SCORING SYSTEM: No data available
Results and discussion
In vitro
- Other effects / acceptance of results:
- no data available
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: Days 1, 3, 5, and 7
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Mild erythema and no edema during the seven days of observation.
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Conclusions:
- Mild erythema and no edema was observed in rabbits during the 7 days of observation after treatment with propylene glycol oleate.
Hence, propylene glycol oleate can be considered not irritating to male albino rabbit skin. - Executive summary:
A Skin irritation study was conducted on albino male rabbit to assess the irritation potential of propylene glycol oleate.The animals were administrated of propylene glycol oleate (1% in tetraglycol: distilled water 1:1, with and without 1% lidocaine).
Propylene glycol oleate was administered to the backs (clipped of hair) of the rabbits in adhesive plasters with an exposure area diameter of 1.5 cm2. The test sites were kept under occlusion except when the dressing was removed on days 1, 3, 5, and 7 only long enough for observation. Then sterile pads were changed and the rabbit’s back reoccluded.
Mild erythema was observed in animals and no edema was observed during the 7 days of observation after treatment with propylene glycol oleate.
Hence, propylene glycol oleate can be considered not irritating to male albino rabbit skin.
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.
