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Toxicological information

Exposure related observations in humans: other data

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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

Reference
Name:
Unnamed
Type:
Constituent
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.

Applicant's summary and conclusion