4-methyl-3-decen-5-ol

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not reported

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was performed to sound scientific principles with a sufficient level of detail to assess the quality of the submitted data.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

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:

Repeated insult patch tests were conducted on 50 human subjects. The volunteers were exposed to 10 dermal applications of 8 different substance during induction exposure and 10 - 24 days after application of the last induction exposure, challenge patches were applied to the original contact sites and also to fresh, adjacent sites. The sites were scored prior to the next patch application during the induction exposure period and at 24 and 48 hours following the challenge application.

GLP compliance:

no

Remarks:

not applicable

Test material

Test material information

Constituent 1

Reference substance name:

4-methyl-3-decen-5-ol

EC Number:

279-815-0

EC Name:

4-methyl-3-decen-5-ol

Cas Number:

81782-77-6

Molecular formula:

C11H22O

IUPAC Name:

4-methyldec-3-en-5-ol

Test material form:

liquid

Method

Type of population:

not specified

Ethical approval:

confirmed and informed consent free of coercion received

Subjects:

- Number of subjects exposed: 60 volunteers (50 volunteers completed the study)- Sex: Male (14) and female (36)- Age: 16 to 65 years

Clinical history:

- History of allergy or casuistics for study subject or populations: All of the subjects did not exhibit any physical or dermatological conditions which would have precluded application of the test materials.

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: patch test (epicutaneous test).ADMINISTRATION- Type of application: occlusive.- Vehicle / solvent: dimethyl phthalate.- Concentrations: 10 % solution of test material in dimethyl phthalate.- Volume applied: 0.2 mL- Testing/scoring schedule: Individuals were scored at 48 hours.MAIN STUDYA. INDUCTION EXPOSURE- Area of Site: 2 cm² on the inner side of the arm or the back of each subject.- Frequency of applications: 10.- Duration of exposure: 24 hours.- Rest period: The subjects removed the patched 24 hours after application. Twenty four hour rest periods followed removals on Tuesdays and Thursdays and 48 hour rest periods followed Saturday removals. This procedure was repeated until 10 applications were performed.- Test groups: 0.2 mL of test material.- Scoring: Sites were scored before each repeat application.- Concentrations: 10 % solution of test material in dimethyl phthalate.B. CHALLENGE EXPOSURE- Time after induction: 10 to 24 days after the last induction application.- Site: Induction site as well as fresh, adjacent site.- No. of exposures: 1.- Concentrations: 10 % test material solution in dimethyl phthalate.- Evaluation (hr after challenge): 24 and 48 hours.EXAMINATIONS- Grading/Scoring system: Volunteers were scored according to the following scale:No reaction = 0Minimal erythema = ±Erythema = 1Erythema and edema = 2Erythema and moderate edema with papules = 3Erythema, marked edema, substantial vesiculation = 4

Results and discussion

Results of examinations:

SYMPTOMS- Slight transient reactions were observed during testing.NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION- Number of subjects with positive reactions: 0- Number of subjects with negative reactions: 40 (10 subjects dropped out during the course of the test due to personal reasons)- Number of subjects with equivocal reactions: 0- Number of subjects with irritating reactions: 0

Any other information on results incl. tables

Table 1: Results (individual scores)

Panellist No.	Age	Sex	Exposure no.										Challenge
													Original		Virgin
			1	2	3	4	5	6	7	8	9	10	24 h	48 h	24 h	48 h
1	25	F	0	0	0	0	0	0	0	0	0	0	0	0	0	0
2	17	M	0	0	0	0	0	0	0	0	0	0	0	0	0	0
3	27	F	0	0	0	0	0	0	0	0	0	0	0	0	0	0
4	49	F	0	0	0	0	0	0	0	0	0	0	0	0	0	0
5	28	F	0	0	0	0	0	0	0	0	0	0	0	0	0	0
6	21	M	Discontinued
7	25	M	0	0	0	0	0	0	0	0	0	0	0	0	0	0
8	45	F	0	0	0	0	0	0	0	0	0	0	0	0	0	0
9	47	F	0	0	0	0	0	0	0	0	0	0	0	0	0	0
10	32	M	0	0	0	0	0	0	0	0	0	0	-*	-*	-*	-*
11	26	M	0	0	0	0	0	0	0	0	0	0	0	0	0	0
12	31	F	0	0	0	0	0	0	0	0	0	0	0	0	0	0
13	23	F	Discontinued
14	40	M	0	0	0	0	0	0	0	0	0	0	0	0	0	0
15	35	F	0	0	0	0	0	0	0	0	0	0	0	0	0	0
16	27	F	0	0	0	0	0	0	0	0	0	0	0	0	0	0
17	32	M	0	0	0	0	0	0	0	0	0	1	0	0	0	0
18	32	F	Discontinued
19	31	F	Discontinued
20	39	F	Discontinued
21	22	F	0	0	0	0	0	0	0	0	0	0	0	0	0	0
22	38	F	0	0	0	0	0	0	0	0	0	0	0	0	0	0
23	26	F	0	0	0	0	0	0	0	0	0	0	0	0	0	0
24	29	F	0	0	0	0	0	0	0	0	0	0	0	0	0	0
25	17	M	0	0	0	0	0	0	0	0	0	0	0	0	0	0
26	18	F	0	0	0	0	0	0	0	0	0	0	0	0	0	0
27	20	F	0	0	0	0	0	0	0	0	0	0	0	0	0	0
28	34	F	0	0	Discontinued
29	27	F	0	0	0	0	0	0	0	0	0	0	0	0	0	0
30	20	F	0	0	0	0	0	0	0	0	0	0	0	0	0	0
31	38	F	0	0	0	0	0	0	0	0	0	0	0	0	0	0
32	34	F	0	0	0	0	0	1	0	0	0	0	0	0	0	0
33	50	F	0	Discontinued
34	42	F	0	Discontinued
35	19	F	Discontinued
36	21	M	0	0	0	0	0	0	0	0	0	0	0	0	0	0
37	24	F	0	0	0	0	0	0	0	0	0	0	0	0	0	0
38	39	F	0	0	0	0	0	0	0	0	0	0	0	0	0	0
39	27	M	0	0	0	0	0	0	0	0	0	0	0	0	0	0
40	60	F	0	0	0	0	0	0	0	0	0	0	0	0	0	0
41	22	M	0	0	0	0	0	0	0	0	0	0	0	0	0	0
42	18	M	0	Discontinued
43	20	F	0	0	0	0	0	0	0	0	0	±	0	0	0	0
44	46	F	0	0	0	0	0	0	0	0	0	0	0	0	0	0
45	34	F	0	Discontinued
46	35	F	0	0	0	0	0	0	0	0	0	0	0	0	0	0
47	31	F	Discontinued
48	65	M	0	0	0	0	0	0	0	0	0	0	0	0	0	0
49	66	F	0	0	0	0	0	0	0	0	0	0	0	0	0	0
50	35	F	0	0	0	0	0	0	0	0	0	0	0	0	0	0
51	30	F	0	0	0	0	0	0	0	0	0	0	0	0	0	0
52	34	F	0	0	0	0	0	0	0	0	*-	-	0	0	0	0
53	35	M	0	0	0	0	0	0	0	0	0	0	0	0	0	0
54	33	F	0	0	0	0	0	0	0	0	0	0	0	0	0	0
55	55	F	0	0	0	0	0	0	0	0	0	0	0	0	0	0
56	29	F	0	0	Discontinued
57	25	M	0	0	0	0	0	±	0	0	0	±	0	0	0	0
58	23	F	0	0	0	0	0	0	0	0	0	±	±	0	±	0
59	26	F	0	0	0	0	0	0	0	0	0	0	0	0	0	0
60	18	F	Discontinued
61	19	F	0	0	0	0	0	0	±	0	0	0	0	0	0	0
62	49	F	0	0	0	0	0	0	0	0	0	0	0	0	0	0
63	17	M	0	0	0	0	0	0	0	0	0	0	0	0	0	0
64	33	F	Discontinued
65	62	F	0	0	0	0	0	0	0	0	0	0	0	0	0	0
- no patch application h hours after application -* no reading taken

 

Applicant's summary and conclusion

Conclusions:

The test material was determined to be not sensitising to human volunteers during a repeat insult patch test at a concentration of 10 %.

Executive summary:

A human repeat insult patch test performed in 50 volunteers at a concentration of 10 % was performed to determine the skin sensitisation potential of the test material. Under the conditions of the test no sensitisation was observed, with only transient reactions noted in a few volunteers during the study.