4'-methoxyacetophenone

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1973-08-13

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

In principle similar to OECD Guideline 406

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Principles of method if other than guideline:

Human Patch Test with with 25 volunteers. No controls with control subjects were carried out, but a preliminary study with a mild irritant reference substance (sodium lauryl sulfate) for reliability check was conducted. This method is based on the visual assessement of erythrema as indicator of contact allergic response in previously sensitized test persons.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

4'-methoxyacetophenone

EC Number:

202-815-9

EC Name:

4'-methoxyacetophenone

Cas Number:

100-06-1

Molecular formula:

C9H10O2

IUPAC Name:

1-(4-methoxyphenyl)ethanone

Method

Type of population:

not specified

Ethical approval:

not specified

Subjects:

- Number of subjects exposed:
- Sex: Male
- Age: 22-62
- Demographic information: None

Clinical history:

Healthy. Not further specified.

Controls:

None

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: Patch test (epicutaneous test)

ADMINISTRATION
- Type of application: Epicutaneous, occlusive
- Description of patch: None
- Vehicle / solvent: Unchanged (no vehicle)
- Concentrations: 6%
- Volume applied: Not specified
- Testing/scoring schedule: Not specified
- Removal of test substance: Not specified


EXAMINATIONS
- Grading/Scoring system: Not specified
- Statistical analysis: None

Results and discussion

Results of examinations:

SYMPTOMS
- Frequency, level, duration of symptoms observed: None

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions (48 h and 72 h after challenge): 0
- Number of subjects with negative reactions (48 h and 72 h after challenge): 25
- Number of subjects with equivocal reactions (48 h and 72 h after challenge): 0
- Number of subjects with irritating reactions (48 h and 72 h after challenge): 0

RESULTS

- 1st reading (48 h after challenge): No indication of skin sensitisation
- 2nd reading (72 h after challenge): No indication of skin sensitisation

Any other information on results incl. tables

Table: Results of the Maximization Test

			Challenge
Subject No.	Age	Race	48-hrs.	72-hrs.
1	24	B	0	0
2	27	B	0	0
3	40	B	0	0
4	22	B	0	0
5	23	B	0	0
6	32	B	0	0
7	22	B	0	0
8	36	B	0	0
9	28	B	0	0
10	28	B	0	0
11	39	B	0	0
12	22	B	0	0
13	31	B	0	0
14	46	B	0	0
15	49	B	0	0
16	25	B	0	0
17	62	B	0	0
18	39	B	0	0
19	23	B	0	0
20	23	B	0	0
21	25	B	0	0
22	25	B	0	0
23	30	B	0	0
24	24	B	0	0
25	24	B	0	0

Applicant's summary and conclusion

Conclusions:

Based on the result of this test, the test item has no skin sensitizing potential.

Executive summary:

The skin sensitising potential of the test item was assessed in a Human Patch Test. Twenty-five healthy male volunteers at age between 22 and 65 years were exposed to the test substance for a five alternate-day 48-hour period. A preliminary study confirmed that sodium lauryl sulfate is suitable for pretreatment in the main test. For pre-treatment, a 5% sodium lauryl phosphate was applied to the patch sites for a duration of 24 hours. After a rest period of ten days, a 10% aquaous solution of sodium lauryl sulfate was applied under occlusion. Afterwards the volunteers were challanged with patches of the test item, applied for 48 hours to fresh sites (occlusive). After 48 hours of exposure the patches were removed and the sites were examined subsequently and 24 hours thereafter. In result there were no signs of contact-sensitisation observeable after a challenge period of 48 and 72 hours (mean score = 0, no visible change). It can be concluded that the test item has no skin sensitizing potential.