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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:
experimental study
Adequacy of study:
supporting study
Study period:
29 Jun - 03 Jul 1998
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Analytical purity of test substance not specified.

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:
other: The test was conducted according to COLIPA standard.
Deviations:
yes
Remarks:
analytical purity of test substance not specified
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 caprylate
- 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).
Slight erythema was seen in 10/20 volunteers, one individual also had slight desquamation (mean score for erythema: 0.53; mean score for erythema, edema, desquamation and fissure: 0.63). The slight reactions occuring under 24 h occlusive test conditions indicate that the undiluted test substance methyl caprylate is not irritating to human skin. The positive test result obtained for SDS confirmed the validity of the test.

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 caprylate

10/20

10

0

0

0

66

0

0

0

0

76

2

0

0

0

74

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

7

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.