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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
Not reported
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
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:
1973
Report date:
1973

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
A Maximisation test was conducting 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 forearms of 25 healthy males volunteers, for five alternate day 48 hour periods. The patch sites were pre-tested for 24 hours with 5% aqueous sodium lauryl sulfate under occlusion. Following a 10 day rest period, challenge patches of the test material were applied under occlusion to fresh sites for 48 hours. Challenge applications were preceded by one hour applications of 10% aqueous sodium lauryl sulfate under occlusion. The challenge sites were read on removal of the patch and 24 hours thereafter.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-phenoxyethyl isobutyrate
EC Number:
203-127-1
EC Name:
2-phenoxyethyl isobutyrate
Cas Number:
103-60-6
Molecular formula:
C12H16O3
IUPAC Name:
2-phenoxyethyl 2-methylpropanoate
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): phenoxyethyl isobutyrate

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 25 (5 volunteers were included in a pre-test)
- Sex: Male
- Age: 21 to 38 years.
- Race: Volunteers were all of the same race group (denoted as B).
- Demographic information: Inmates were used as volunteers, no other demographic information is available in the report.
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 5 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.
- Resutls of pre-test: No subject had any irritation from the test material and it was decided to use sodium lauryl sulfate as a pre-treatment in the test.

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 days 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, 1 hour 10 % aqueous sodium lauryl sulphate applications were performed.
- Concentrations: Not reported.
- Testing/scoring schedule: the challenge site was assessed for dermal reactions on removal of the patch and 24 hours thereafter.

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

Subject No.

Age

Race

Challenge

48 hours

72 hours

1

21

B

0

0

2

29

B

0

0

3

22

B

0

0

4

24

B

0

0

5

25

B

0

0

6

33

B

0

0

7

21

B

0

0

8

33

B

0

0

9

22

B

0

0

10

27

B

0

0

11

38

B

0

0

12

22

B

0

0

13

32

B

0

0

14

22

B

0

0

15

26

B

0

0

16

23

B

0

0

17

22

B

0

0

18

27

B

0

0

19

27

B

0

0

20

35

B

0

0

21

23

B

0

0

22

28

B

0

0

23

27

B

0

0

24

24

B

0

0

25

31

B

0

0

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 sensitizer.
Executive summary:

A maximisation test was conducting 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 test, the test material was applied under occlusion to sites on the volar forearms of 25 healthy male volunteers, 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 day rest period, challenge patches of the test material were applied under occlusion to fresh sites for 48 hours. Challenge applications were preceded by one hour applications of 10 % aqueous sodium lauryl sulfate under occlusion. The challenge sites were read on removal of the patch and 24 hours thereafter.

Before the maximisation test was conducted, the test material was pre-tested on 5 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. No subject had any irritation from the test material and it was decided to use sodium lauryl sulfate as a pre-treatment in the test.

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 sensitizer.

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