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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:
1998-06-29 to 1998-07-03
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:
1998
Report date:
1998

Materials and methods

Study type:
study with volunteers
Endpoint addressed:
skin irritation / corrosion
Test guideline
Qualifier:
according to guideline
Guideline:
other: COLIPA
Deviations:
yes
Remarks:
lack of details on test substance
Principles of method if other than guideline:
70 µL of the test substances are applied on the back of volunteers for 24 h with occlusive patches (Fin Chamber on Scanpor, 12 mm). The skin is subsequently examinated at 6, 24, 48 and 72 h and effects are graded according to the scale of Frosch and Kligman (1979).
GLP compliance:
no
Remarks:
GCP compliant (incl. certificate)

Test material

Constituent 1
Chemical structure
Reference substance name:
Methyl palmitate
EC Number:
203-966-3
EC Name:
Methyl palmitate
Cas Number:
112-39-0
Molecular formula:
C17H34O2
IUPAC Name:
methyl palmitate
Details on test material:
- Name of test material (as cited in study report): Methyl palmitate
- Analytical purity: no data

Method

Type of population:
general
Subjects:
- Number of subjects exposed: 20
- Sex: male and female
- Age: without restriction, not documented
Ethical approval:
confirmed and informed consent free of coercion received
Route of exposure:
dermal
Reason of exposure:
intentional
Exposure assessment:
measured
Details on exposure:
70 µL of the test substances are applied on the back of volunteers for 24 h with occlusive patches (Fin Chamber on Scanpor, 12 mm).
Examinations:
The skin is subsequently examinated at 6, 24, 48 and 72 h and effects are graded according to the scale of Frosch and Kligman (1979).
Medical treatment:
No

Results and discussion

Clinical signs:
No erythema and four cases with slight desquamation were detected

Scores for test substance (mean of all volunteers):
Erythem: 0.21
Erythema, Edema, Desquamation and fissure: 0.47
Results of examinations:
Aim of these 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. SDS) and negative controls (e.g. water). 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 palmitate 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 and differentiated according to the strength.

 

 

Erythema

Edema

Desquamation

Substance

Without reaction

1

2

3

4

0

1

2

3

4

0

1

2

3

4

0

Methyl palmitate

16/20

4

0

0

0

72

0

0

0

0

76

5

0

0

0

71

 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

Parrafin 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., 1979, 1, pp. 35-41:

0 = no reactions

0.5 = minimal or doubtful reactions

1 = slight reactions

2 = moderate reactions

3 = strong uniform reactions

4 = very strong 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 sufficient 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 these effects leads to the classification of the test substance methyl palmitate as not irritating to human skin.