Ethyl 2-methyl-1,3-dioxolane-2-acetate

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

not reported

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

The methodology and results were reported in very limited detail. It was not possible to assess the quality of the reported results from the data presented. From the limited information available, the study appears to have been conducted in compliance with good scientific principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Principles of method if other than guideline:

A Maximisation test was conducted in line with the method described in the Journal of Investigative Dermatology, Volume 47, No. 5; 1966; 393-409. During the test, the test material was applied under occlusion to the same sites on the volar aspects of the forearms of all subjects, for five alternate day 48 hour periods. The patch sites were pre-tested for 24 hours with 5 % aqueous sodium lauryl sulphate under occlusion for the initial patch only. Following a 10-14 day rest period, challenge patches of the test material were applied under occlusion for 48 hours. Challenge applications were preceded by 30 minute applications of 5 % aqueous sodium lauryl sulphate under occlusion for without sodium lauryl sulphate treatment on the right side. Additional sodium lauryl sulphate controls were placed on the left and petroleum on the right. The challenge sites were read at 48 and 72 hours. Questionable reactions were biopsied and subjects re-tested whereby the test material was applied at new sites one week later and examined in the same manner.

GLP compliance:

no

Remarks:

study pre-dates GLP

Test material

Test material information

Constituent 1

Reference substance name:

Ethyl 2-methyl-1,3-dioxolane-2-acetate

EC Number:

229-114-0

EC Name:

Ethyl 2-methyl-1,3-dioxolane-2-acetate

Cas Number:

6413-10-1

Molecular formula:

C8H14O4

IUPAC Name:

ethyl 2-(2-methyl-1,3-dioxolan-2-yl)acetate

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 35 healthy inmate volunteers were screened, and 32 completed the study (see Tables 1 and 2).
- Sex: Male
- Age: 21 - 49

Clinical history:

The volunteers were reported as healthy.

Route of administration:

dermal

Details on study design:

PRE-TEST
- Method: Before the Maximisation test was conducted, the test material was pre-tested on all subjects in order to determine whether sodium lauryl sulfate pre-treatment was required. A patch of the test material was applied to normal sites on the backs for 48 hours under occlusion.
- Results of pre-test: No significant evidence of irritation was observed and all subjects were pre-tested with 5 % aqueous sodium lauryl sulphate.

TYPE OF TEST USED: Maximization test (epicutaneous test).

ADMINISTRATION
- Pre-treatment of test site: The test site on the volar forearm was pre-treated for 24 hours with 5% aqueous sodium lauryl sulphate under occlusion.
- Type of application: occlusive.
- Induction exposure: Five 48 hour exposures on alternative days.
- Rest period: A 10-14 day rest period was left between the induction and challenge exposures.
- Challenge exposure: 48 hour applications to fresh test sites.
- Post-exposure treatment: Preceding the challenge application, 30 minute 2 % aqueous sodium lauryl sulphate applications were performed without sodium lauryl sulphate treatment on the right side. Additional sodium lauryl sulphate controls were placed on the left and petroleum on the right.
- Concentrations: Not reported.
- Testing/scoring schedule: the challenge site was assessed for dermal reactions on removal of the patch at 48 and 72 hours.

Results and discussion

Results of examinations:

There were no instances of contact-sensitization in any of the volunteer’s exposed to the test material.

Any other information on results incl. tables

Table 1: Results (treatment sites)

Subject no.	Challenge				Race	Age	Sex
	SLS		No SLS
	48 hours	72 hours	48 hours	72 hours
1	0	0	0	0	WHITE	40	M
2	+-	B	+-	0	WHITE	45	M
3	0	0	0	0	MEXICAN	34	M
4	0	0	0	0	ORIENTAL	33	M
5	PAROLED				WHITE	33	M
6	0	0	0	0	WHITE	35	M
7	PAROLED				MEXICAN	34	M
8	+-	0		0	BLACK	29	M
9	+-	0	0	0	BLACK	27	M
10	0	0	0	0	WHITE	28	M
11	0	0	0	0	INDIAN	25	M
12	+-	0	0	0	WHITE	28	M
13	0	0	0	0	WHITE	28	M
14	0	0	+-	0	INDIAN	29	M
15	0	0	0	0	BLACK	29	M
16	0	0	0	0	WHITE	31	M
17	TRANSFERRED				BLACK	31	M
18	0	0	0	0	WHITE	26	M
19	+-	0	+-	+-	WHITE	23	M
20	+-	0	+-	0	WHITE	28	M
21	0	B	+-	0	WHITE	32	M
22	+-	0	0	0	BLACK	43	M
23	0	0	0	0	BLACK	23	M
24	0	B	0	0	WHITE	42	M
25	0	0	+-	0	BLACK	24	M
26	0	0	0	0	BLACK	38	M
27	+-	0	+-	0	BLACK	42	M
28	0	0	0	0	WHITE	29	M
29	0	0	0	0	BLACK	35	M
30	+-	B	0	0	WHITE	40	M
31	0	0	+-	0	WHITE	44	M
32	+-	H	+-	0	BLACK	36	M
33	0	0	0	0	WHITE	49	M
34	+-	B	0	0	WHITE	21	M
35	0	0	0	0	INDIAN	32	M

Table 2: Results (control sites)

Subject no.	Challenge				Race	Age	Sex
	SLS		No SLS
	48 hours	72 hours	48 hours	72 hours
1	0	0	0	0	WHITE	40	M
2	+-	B	0	B	WHITE	45	M
3	+-	B	0	0	MEXICAN	34	M
4	0	0	0	0	ORIENTAL	33	M
5	PAROLED				WHITE	33	M
6	0	0	0	0	WHITE	35	M
7	PAROLED				MEXICAN	34	M
8	+-	0	+-	0	BLACK	29	M
9	0	0	0	0	BLACK	27	M
10	0	0	0	0	WHITE	28	M
11	0	0	0	0	INDIAN	25	M
12	0	0	0	0	WHITE	28	M
13	0	0	0	0	WHITE	28	M
14	+-	0	0	0	INDIAN	29	M
15	0	0	0	0	BLACK	29	M
16	0	0	0	0	WHITE	31	M
17	TRANSFERRED				BLACK	31	M
18	+-	0	+-	0	WHITE	26	M
19	0	0	0	0	WHITE	23	M
20	0	0	0	0	WHITE	28	M
21	0	B	0	0	WHITE	32	M
22	0	0	0	0	BLACK	43	M
23	0	0	0	0	BLACK	23	M
24	0	B	0	0	WHITE	42	M
25	0	0	0	0	BLACK	24	M
26	0	0	0	0	BLACK	38	M
27	+-	0	0	0	BLACK	42	M
28	0	0	0	0	WHITE	29	M
29	0	0	0	0	BLACK	35	M
30	0	B	0	0	WHITE	40	M
31	0	0	+-	0	WHITE	44	M
32	0	0	0	0	BLACK	36	M
33	0	0	0	0	WHITE	49	M
34	0	0	0	0	WHITE	21	M
35	0	0	0	0	INDIAN	32	M

Applicant's summary and conclusion

Conclusions:

There were no instances of contact sensitisation from the test material during the Maximisation Test. It is therefore considered unlikely that the test material is a skin sensitiser.

Executive summary:

A Maximisation Test was conducted to determine the skin sensitisation potential of the test material in line with the method described in the Journal of Investigative Dermatology, Volume 47, No. 5; 1966 p 393-409. During the study, the test material was applied under occlusion to sites on the volar aspects of the forearms of all subjects, for five 48 hour periods administered on alternate days. The patch sites were pre-tested for 24 hours with 5 % aqueous sodium lauryl sulfate under occlusion. Following a 10 -14 day rest period, challenge patches of the test material were applied under occlusion to fresh sites for 48 hours. Challenge applications were preceded by 30 minute applications of 2 % aqueous sodium lauryl sulphate under occlusion without sodium lauryl sulphate treatment on the right side. Additional sodium lauryl sulphate controls were placed on the left and petroleum on the right. The challenge sites were read at 48 and 72 hours. Questionable reactions were biopsied and followed by retests, whereby the test material was applied at new sites one week later; they were examined in the same manner.

Before the Maximisation Test was conducted, the test material was pre-tested on all subjects in order to determine whether sodium lauryl sulphate pre-treatment was required. A patch of the test material was applied to normal sites on the backs for 48 hours under occlusion. No significant evidence of irritation was observed and all subjects were pre-tested with 5% sodium lauryl sulphate.

Under the conditions of the study there were no instances of contact sensitisation from the test material during the Maximisation Test. It is therefore considered unlikely that the test material is a skin sensitiser.