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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:
weight of evidence
Study period:
From January 31, 1997 to March 13, 1997
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

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:
The method is based on Modified Draize test. In a test the human volunteers are subjected to a continuous induction period with patch exchange 3 times a week until a total of 10 patches have been applied. The patches are reapplied to the same site, and only if moderate inflammation has developed, the next patch is moved to an adjacent skin site. Each induction site is evaluated for erythema and edema after removal of the patch. Challenge is performed on naive skin two weeks later with a 72 h patch test with a non-irritating concentration of the substance. The response after challenge is compared to the responses reported after the early induction patches.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified

Method

Type of population:
general
Ethical approval:
confirmed and informed consent free of coercion received
Subjects:
Fifty eight (58) subjects, male and female, ranging in age from 17 to 75 years, were selected for this evaluation. Fifty seven (57) subjects completed this study. The remaining subject discontinued her participation for personal reasons, none of which were related to the application of the test substance.
Clinical history:
Inclusion Criteria:
1) Willingness to cooperate
2) Absence of any visible skin disease which might be confused with a skin reaction from the test material
3) Prohibition of use of topical or systemic steroids and/or antihistamines for at least seven days prior to study initiation.
4) Reading, understanding and signing of a Consent form.
5) Considered reliable and capable of following directions.
Controls:
Not specified
Route of administration:
dermal
Details on study design:
Methodology:
Prior to the initiation of the study, the test substance was prepared as a 10% dilution using distilled water. The upper back between the scapulae served as the treatment area. Approximately 0.2 mL of the test substance, or an amount sufficient to cover the contact surface, was applied to the 1" x 3/4" absorbent gauze portion of a clear adhesive dressing (Manufactured by Fabco Inc., Old Mystic, CT). This was then to the appropriate treatment site to form a semi-occluded patch.

Induction Phase:
Patches were applied three (3) times per week (e.g., Monday, Wednesday, and Friday) for a total of ten (10) applications. The site was marked to ensure the continuity Of patch application. Following supervised removal and scoring of the first Induction patch, participants were instructed to remove all subsequent Induction patches at home, twenty four hours after application. The evaluation of this site was made again just prior to re-application. If a participant was unable to report for an assigned test day, one (1) makeup day was permitted. This day was added to the Induction period. With the exception of the first supervision Induction Patch reading, if any test site exhibited a moderate (2-level) reaction during the Induction Phase, application was moved to an adjacent area. Applications are discontinued for the remainder of this test phase, if a moderate (2-level) reaction observed
on this new test site. Applications would also be discontinued if marked (3- level) or severe (4-level) reactivity was noted. Rest periods consist of twenty-four hours following each Tuesday and Thursday removal, and forty-eight hours following each Saturday removal.

Challenge phase:
Approximately two (2) weeks after the final Induction patch application, a Challenge patch was applied to the original and to a Virgin test site. The patch was removed and the site scored at the clinic twenty-four and seventy-two hours post-application. The volar forearm served as the virgin test site.

Evaluation Key:
0 = No visible skin reaction
1 = Mild erythema
2 = Well defined erythema, possible presence of barely perceptible edema
3 = Erythema and edema
4 = Erythema and edema with vesiculation and ulceration

Results and discussion

Results of examinations:
Observations remained negative throughout the test interval. Under the conditions of this study, test substance did not indicate a potential for dermal irritation or allergic contact sensitization.

Any other information on results incl. tables

Individual test results

Subject number

Induction phase

Original site

Virgin challenge site

24 h

1

2

3

4

5

6

7

8

9

10

24 h

72 h

24 h

72 h

1

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

2

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

3

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

4

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

5

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

6

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

7

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

8

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

9

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

10

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

11

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

12

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

13

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

14

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

15

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

16

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

17

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

18

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

19

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

20

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

21

0

0

0

0

0

0

Did not complete study

22

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

23

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

24

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

25

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

26

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

27

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

28

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

29

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

30

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

31

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

32

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

33

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

34

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

35

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

36

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

37

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

38

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

39

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

40

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

41

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

42

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

43

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

44

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

45

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

46

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

47

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

48

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

49

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

50

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

51

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

52

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

53

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

54

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

55

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

56

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

57

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

58

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Applicant's summary and conclusion

Conclusions:
Under the study conditions, test substance did not indicate a potential for dermal irritation or allergic contact sensitization.
Executive summary:

A study was conducted to determine the skin sensitisation potential of a test substance, Hydrolysed keratin from wool (active: 2.3%) to induce primary or cumulative irritation and/or allergic contact sensitization in repeat insult patch test in humans (HRIPT). Fifty eight human volunteers, male and female, ranging in age from 17 to 75 years, were selected for this evaluation (fifty seven human volunteers completed this study, while remaining subject discontinued her participation for personal reasons, none of which were related to the application of the test substance). Prior to the initiation of the study, the test substance was prepared as a 10% dilution using distilled water. Approximately 0.2 mL of the test substance, or an amount sufficient to cover the contact surface, was applied to the 1" x 3/4" gauze portion of a clear adhesive dressing. This was then applied to the upper back between the scapulae to form a semi-occluded patch. Patches were applied three times per week for a total of ten applications. The participants were instructed to remove all subsequent induction patches at home, 24 h after application. The evaluation of this site was made again just prior to re-application. If a participant was unable to report for an assigned test day, one makeup day was permitted. This day was added to the induction period. With the exception of the first supervision induction patch reading, if any test site exhibited a moderate (2-level) reaction during the induction phase, application was moved to an adjacent area. Applications were discontinued for the remainder of this test phase, if a moderate (2 -level) reaction observed on this new test site. Applications were also discontinued if marked (3- level) or severe (4-level) reactivity was noted. Rest periods consist of 24 h following each Tuesday and Thursday removal, and 48 h following each Saturday removal. Approximately two weeks after the final induction patch application, a challenge patch was applied to the original site and to a virgin test site. The patch was removed and the site scored at the clinic 24 h and 72 h post-application. The volar forearm served as the virgin test site. Based on the grading and evaluations of study results, the study author concluded that test substance did not induce dermal irritation or allergic contact sensitization throughout the test interval (CPT, 1997).