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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: non-GLP, insufficient documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
according to guideline
Guideline:
other: J.I.D.; Vol. 47; No. 5; 393-409; 1966
Principles of method if other than guideline:
Human Patch test
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Allyl hexanoate
EC Number:
204-642-4
EC Name:
Allyl hexanoate
Cas Number:
123-68-2
Molecular formula:
C9H16O2
IUPAC Name:
allyl hexanoate
Details on test material:
- Name of test material (as cited in study report): Allyl hexanoate
- Analytical purity: not reported
- Impurities (identity and concentrations): not reported

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
25 female and male human volunteers
Clinical history:
No data
Route of administration:
dermal
Details on study design:
pre-treatment for 24 hours with 5 % aqueous sodium lauryl sulfate

Occlusive epicutaneous induction and challenge exposure

- No. of exposures: one
- Day(s) of challenge: not reported
- Exposure period: not reported
- Test groups: no
- Control group: no
- Site: not reported
- Concentrations: pure
- Evaluation (hr after challenge): on patch removal and 24 hours later (48 and 72 hours after application)

Results and discussion

Results of examinations:
14 out of 25 tested individuals had a positive skin reaction at the reading following 48 hours after challenge exposure.
13 out of 25 tested individuals had a positive skin reaction at the reading following 72 hours after challenge exposure.

Any other information on results incl. tables

Maximization results of Allyl hexanoate

Subject No.

Age

Race

Sex

Challenge

48 hours

72 hours

1

29

B

F

0

0

2

42

W

F

3

3

3

27

B

F

3

2

4

20

W

M

0

0

5

36

W

M

0

0

6

20

W

M

0

0

7

20

W

M

2

2

8

19

W

F

3

3

9

22

W

M

3

3

10

23

W

F

3

2

11

40

B

F

2

1

12

25

B

F

2

1

13

28

W

M

2

1

14

21

W

F

3

3

15

29

W

F

0

0

16

36

W

M

0

0

17

41

W

F

1

1

18

48

B

M

1

0

19

37

B

M

1

1

20

31

B

F

0

0

21

29

B

F

2

1

22

31

B

M

0

0

23

25

W

F

0

0

24

22

B

F

0

0

25

22

B

F

0

0

 

Additional information:

Magnusson and Kligman grading scale for the evaluation of challenge patch test reactions

0

no visible change

1

discrete or patchy erythema

2

moderate and confluent erythema

3

intense erythema and swelling

Applicant's summary and conclusion

Conclusions:
Allyl hexanoate produced 13 cases of sensitization (out of 25) and should be considered a moderate sensitizer.
Executive summary:

10 male and 15 female volunteers completed the study. Following a 24-hour pre-treatment with 5 % aqueous sodium lauryl sulfate under occlusion, the pure test material was applied under occlusion to the volar forearms of all subjects for 48 hour periods. The challenge sites were read on removal of the patch (after 48 hour exposure) and 24 hours thereafter.

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