3-(p-methoxyphenyl)-2-methylpropionaldehyde

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

16 Jun 2008 to 25 Jul 2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

- Principle of test: repeated insult patch test
- Short description of test conditions: During the induction phase 0.3 mL of test material was applied to a Webril/ adhesive patch (25 mm Hill Top Chamber system), which was applied occlusively on Mondays, Wednesdays and Fridays. The test side (left site of the back) was wiped with a dry Kimwipe prior to patching. The patches were removed after 24 hours and no test material was applied for 24 hours or 48 hours (after the Friday application). In total a series of 9 induction patches were completed over a period of approximately 3 weeks. In the rest period, approximately 2 weeks, no test material was applied. During the challenge phase, the original induction sites were observed. The virgin right back site was usually used for the challenge phase. After 24 hours the patches were removed and the induction and challenge site were observed. Additional observations were made after 48, 72 and 96 hours.
-Scoring system: the sites were scored using the modified scoring scale of the international contact dermatitis research group system (1986)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-(p-methoxyphenyl)-2-methylpropionaldehyde

EC Number:

226-749-5

EC Name:

3-(p-methoxyphenyl)-2-methylpropionaldehyde

Cas Number:

5462-06-6

Molecular formula:

C11H14O2

IUPAC Name:

3-(4-methoxyphenyl)-2-methylpropanal

Test material form:

liquid

Method

Type of population:

general

Ethical approval:

confirmed and informed consent free of coercion received

Subjects:

- Number of subjects exposed: 126
- Sex: male (42) and female (84)
- number of subjects completed the test: 104 (33 male and 71 female)
- Age: 18 to 68

Clinical history:

- Did not exhibit any dermatological or other medical or physical condition which would preclude topical application.
- Not known pregnant nor nursing.
- An appropriate clearance period had elapsed since a subject was patched on a repeated insult patch test or a photo allergy test before being used in this study.

Route of administration:

dermal

Details on study design:

TYPE OF TEST USED:
repeated insult patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive
- Description of patch: 25 mm Hill Top Chamber System
- Vehicle / solvent: no
- Concentrations: pure substance
- Volume applied: 0.3 mL
- Testing/scoring schedule: after 24 or 48 hours (induction phase) and 24, 48, 72 and 96 hours (challenge phase)
- Removal of test substance: Patches were removed by technicians, except at Saturdays when the subjects removed the patches themselves, 24 hours after start of exposure.
- A series of nine (9) induction patches were completed over a period of approximately three weeks.
- Canthoxal concentration in the solution is 5%.
EXAMINATIONS
- Grading/Scoring system: modified scoring scale of the international contact dermatitis research group system (1986)

Results and discussion

Results of examinations:

0/104 subjects responded to the treatment

Applicant's summary and conclusion

Conclusions:

Application of 0.3 mL with 5% test substance was not sensitising under the conditions of the test.

Executive summary:

The basic schedule was kept in the induction phase every Monday, Wednesday and Friday till 9 applications had been made in approximately 3 weeks. The test concentration used was 5%. During the induction patches were placed at the left side of the back. Technicians removed the patches 24 hours after application, except for Saturdays on which the patients removed the patches themselves. After removal 24 hours without treatment were conducted, except for the 48 hours treatment free period after the Friday application. After two weeks a challenge patch was applied to the virgin right side of the back and removed after 24 hours. Reactions to the challenge were assessed after 24, 48, 72 and 96 hours. None of the 104 subjects tested was sensitized by the sample. It was therefore concluded that the test substance is not sensitizing.