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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:
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:
1998
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

Constituent 1
Chemical structure
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
- Analytical purity: no data

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).
Ten cases of slight erythema (grade 1) and three cases of slight desquamation (grade 1) were observed over all reading time points; 14/20 subjects were without reaction. The slight reactions occurring under these conditions demonstrated that the test substance is well tolerated by normal skin and does not have to be considered as irritating to human skin. The mean irritation score over all subjects was 0.53 for erythema and 0.68 for the combination of the parameters erythema, edema, desquamation and fissures. Referring to the positive test substances, corresponding scores for SDS were 3.21 and 4.89, respectively; for Texapon N28 the scores were 1.47 and 2.63, respectively.

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 laurate

14/20

10

0

0

0

66

0

0

0

0

76

3

0

0

0

73

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.