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Toxicological information

Direct observations: clinical cases, poisoning incidents and other

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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:
1994
Report Date:
1994

Materials and methods

Study type:
study with volunteers
Endpoint addressed:
skin irritation / corrosion
Test guideline
Qualifier:
according to
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
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

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