Registration Dossier
Registration Dossier
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EC number: 204-680-1 | CAS number: 124-10-7
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 29 Jun - 03 Jul 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test procedure in accordance with generally accepted scientific standards and described in sufficient detail.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
- Type of study / information:
- study with volunteers
- Endpoint addressed:
- skin irritation / corrosion
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: The test was conducted according to COLIPA standard.
- Deviations:
- yes
- Remarks:
- lack of details on test substance
- GLP compliance:
- no
- Remarks:
- but GCP compliant
Test material
- Reference substance name:
- Methyl myristate
- EC Number:
- 204-680-1
- EC Name:
- Methyl myristate
- Cas Number:
- 124-10-7
- Molecular formula:
- C15H30O2
- IUPAC Name:
- methyl myristate
- Details on test material:
- - Name of test material (as cited in study report): Methyl myristate
- Analytical purity: no data
Constituent 1
Method
- Ethical approval:
- confirmed and informed consent free of coercion received
- Details on study design:
- Subjects:
- Number of subjects exposed: 20
- Sex: male and female
- Age: without restriction, not documented
Type of exposure:
Dermal, under occlusive conditions.
Study conduct:
An amount of 70 µL of the test substance was applied on the back of volunteers for 24 h with occlusive patches (Fin Chamber on Scanpor, 12 mm). The skin was subsequently examinated at 6, 24, 48 and 72 h and effects were graded according to the scale of Frosch and Kligman, J Am Acad Dermatol 1: 35-41, 1979.
Reference substances:
The following substances were used as references: Cosmet. alcohol, paraffin oil, Texapon N28 (1%), SDS, water, and phys. sodium chloride (NaCl). - Exposure assessment:
- measured
Results and discussion
- Results:
- The aim of this test method is the induction of skin reactions with concentrations of test substances higher than the commercial use (e.g. undiluted) for comparison of the reactions with positive (e.g. sodium dodecyl sulfate (SDS)) and negative controls (e.g. water).
Slight erythema was seen in 2/20 volunters and one case had strong erythema; four individuals showed slight desquamation. The mean score was 0.47 for erythema and 0.68 for erythema, edema, desquamation and fissure.
The slight reactions occurring under these test conditions of occlusive dressing for 24h with the undiluted test substance and the valid positive control SDS lead to the result, that the test substance methyl myristate is not irritating to human skin.
Any other information on results incl. tables
Number of reactions for the parameters erythema, edema and desquamation added up from all time points (6, 24, 48, and 72 h) and differentiated according to the strength.
Scoring |
|
Erythema |
Edema |
Desquamation |
||||||||||||
Substance |
Without reaction |
1 |
2 |
3 |
4 |
0 |
1 |
2 |
3 |
4 |
0 |
1 |
2 |
3 |
4 |
0 |
Methyl myristate |
17/20 |
6 |
0 |
1 |
0 |
69 |
0 |
0 |
0 |
0 |
76 |
4 |
0 |
0 |
0 |
72 |
SDS 0.5% |
2/20 |
39 |
11 |
0 |
0 |
26 |
1 |
0 |
0 |
0 |
75 |
25 |
3 |
0 |
0 |
48 |
Water |
19/20 |
1 |
0 |
0 |
0 |
75 |
0 |
0 |
0 |
0 |
76 |
0 |
0 |
0 |
0 |
76 |
Cosmet. alcohol |
18/20 |
2 |
0 |
0 |
0 |
74 |
0 |
0 |
0 |
0 |
76 |
5 |
0 |
0 |
0 |
71 |
Paraffin oil |
20/20 |
0 |
0 |
0 |
0 |
76 |
0 |
0 |
0 |
0 |
76 |
0 |
0 |
0 |
0 |
76 |
Texapon N28 1% |
7/20 |
28 |
0 |
0 |
0 |
48 |
0 |
0 |
0 |
0 |
76 |
22 |
0 |
0 |
0 |
54 |
Phys. NaCl |
19/20 |
2 |
0 |
0 |
0 |
74 |
0 |
0 |
0 |
0 |
76 |
1 |
0 |
0 |
0 |
75 |
Scoring according to Frosch P.J. & Kligman A.M., The soap chamber test; a new method for assessing the irritancy of soaps, J Am Acad Dermatol 1: 35-41, 1979
0 = no reactions
0.5 = minimal or doubtful reactions
1 = slight reactions
2 = moderate reactions
3 = strong uniform reactions
Applicant's summary and conclusion
- Conclusions:
- The study guideline from COLIPA is in accordance with generally accepted scientific standards, which makes the study report acceptable for assessment. According to C&L guide Art. 3.2.6.1. (EC, 1993a) R38 is to be applied to “substances and preparations which cause significant inflammation of the skin, based on practical observation in humans on immediate, prolonged or repeated contact”. The lack of such effects leads to the classification of the test substance methyl caprylate as not irritating to human skin.
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