Methyl myristate

Direct observations: clinical cases, poisoning incidents and other

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

Test material information

Constituent 1

Reference substance name:

Methyl oleate

EC Number:

203-992-5

EC Name:

Methyl oleate

Cas Number:

112-62-9

Molecular formula:

C19H36O2

IUPAC Name:

methyl (Z)-octadec-9-enoate

Details on test material:

- Name of test material (as cited in study report): methyl oleate
- 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:

One volunteer developed a slight erythema.

Scores for test substance (mean of all volunteers):
Erythem: 0.11
Erythema, Edema, Desquamation and fissure: 0.11

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 oleate 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 oleate	19/20	2	0	0	0	74	0	0	0	0	76	0	0	0	0	76
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 oleate as not irritating to human skin.