Fatty acids, C12-16 (even numbered) and C18 unsatd., Me esters

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:

1994

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

Test material information

Constituent 1

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%

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.