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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 629-780-6 | CAS number: 1234694-02-0
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Study period:
- 16 Dec 1993 - 21 Feb 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
- Type of study / information:
- study with volunteers
- Endpoint addressed:
- skin irritation / corrosion
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The test was conducted according to the method of Burckhardt (Dermatologica 126:37-46, 1964). The test item was applied epicutaneously for 30 minutes (repeated application every 30 seconds) on a skin area of 3 cm diameter, under open conditions, on the inside of the forearms of volunteers. Four different concentrations were tested, 10, 20, 50 and 100%.
- GLP compliance:
- no
- Remarks:
- but GCP compliant
Test material
- Reference substance name:
- Methyl laurate
- EC Number:
- 203-911-3
- EC Name:
- Methyl laurate
- Cas Number:
- 111-82-0
- Molecular formula:
- C13H26O2
- IUPAC Name:
- methyl laurate
- Details on test material:
- - Name of test material (as cited in study report): Methyl laurate
- Physical state: colourless liquid
- Purity: 98 - 100%
Constituent 1
Method
- Ethical approval:
- confirmed and informed consent free of coercion received
- Details on study design:
- Application of test item was repeated every 30 seconds for a period of overall 30 minutes on the inside of the forearms of volunteers under open conditions.
- Exposure assessment:
- measured
- Details on exposure:
- - Number of subjects exposed: 60
- Number of subjects per dose: 20 (at 50 % and 100 %)
- Number of subjects per dose: 10 (at 10 and 20 %)
- Sex: male and female
- Age:
- - 1st test: mean 33 years
- - 2nd test: mean 42.5 years
- - 3rd test: 37.9 years
Results and discussion
- Results:
- Upon 30 minutes exposure to different concentrations of methyl laurate up to 100 % in human volunteers, under open conditions, no skin irritating potential was observed.
Applicant's summary and conclusion
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.
