Registration Dossier
Registration Dossier
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EC number: 204-680-1 | CAS number: 124-10-7
Direct observations: clinical cases, poisoning incidents and other
Administrative data
- Endpoint:
- direct observations: clinical cases, poisoning incidents and other
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Study period:
- 1993-12-16 to 1994-02-21
- 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
- Study type:
- study with volunteers
- Endpoint addressed:
- skin irritation / corrosion
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Burckhardt (Dermatologica 129:37-46, 1964)
- Deviations:
- no
- Principles of method if other than guideline:
- The test item was applied epicutaneously for 30 min (application every 30 sec.) on and skin area of 3 cm diameter on the inside of the forearms. 4 different concentrations were tested, 10, 20, 50 and 100%.
- GLP compliance:
- no
- Remarks:
- 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
- Type of population:
- general
- Subjects:
- - 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
- Ethical approval:
- confirmed and informed consent free of coercion received
- Route of exposure:
- dermal
- Reason of exposure:
- intentional
- Exposure assessment:
- measured
- Details on exposure:
- Application of test item was repeated every 30 sec for a time of overall 30 min on the inside of the forearm of the volunteers under open conditions.
- Medical treatment:
- No
Results and discussion
- Clinical signs:
- None of the volunteers exhibited any reaction to the treatment.
- Results of examinations:
- Upon 30-minutes exposure to different concentrations of methyl laurate up to 100 % in human volunteers 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.
