Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Toxicological information

Exposure related observations in humans: other data

Currently viewing:

Administrative data

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
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference Type:
study report
Report date:

Materials and methods

Type of study / information:
study with volunteers
Endpoint addressed:
skin irritation / corrosion
Test guideline
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:
but GCP compliant

Test material

Constituent 1
Chemical structure
Reference substance name:
Methyl laurate
EC Number:
EC Name:
Methyl laurate
Cas Number:
Molecular formula:
methyl laurate
Details on test material:
- Name of test material (as cited in study report): Methyl laurate
- Physical state: colourless liquid
- Purity: 98 - 100%


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:
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

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