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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:
August 30 to November 5, 1971
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report Date:
1971

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Adaptation of the method of Draize: Test materials were applied nine times under a patch to the upper arms of the panelists during 24 hours every 2/3 days (induction phase). Eight different samples were tested simultaneously on each panelist. Each patch is applied to the same area each time unless the severity of a reaction made this inadvisable. A two week rest period followed the induction phase. For the final challenge application, duplicate patches were applied and readings were made.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Name as cited in the study report: Group 90, BP-10-11 and BP-10-11L
Specific details on test material used for the study:
Date of receipt: July 24, 1971

Method

Type of population:
not specified
Ethical approval:
not specified
Subjects:
Panelists were recruited from: St. Aloysius Church, Bridgetown, Ohio; Sycamore United Presbyterian Church, Loveland, Ohio; Hill Top Research, Inc., Miamiville, Ohio.
- Number of subjects recruited: 22
- Number of subjects exposed: 22
- Sex: 3 men and 19 women
- Age: 21-30 yr: 1M/5F ; 31-40 yr: 0M/8F ; 41-50 yr: 0M/4F ; 51-60 yr: 2M/1F ; >60 yr: 0M/1F.
Clinical history:
See 'Overall remarks, attachments'
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: Patch test (epicutaneous test)

ADMINISTRATION
- Type of application: Not specified if semi-occlusive or occlusive
- Description of patch: 1x1-inch Webril swatch affixed to the center of a 1x2-inch elastic bandage prepared on special order by Duke Laboratories.
- Frequency: Induction phase: 9 times for three weeks during 24 hours; Challenge phase: once during 24 hours
- Duration: Induction phase: 3 weeks; Duration Resting phase: 2 weeks; Challenge phase: 5 days
- Testing/scoring schedule: see 'Any other information on materials and methods incl. tables'
- Concentrations: Undiluted
- Volume applied: 0.5 mL was applied to the Webril swatch by means of a calibrated dropper before application to the skin
- Removal of patches: The panelists were instructed to remove the patches 24 hours after application.
- Removal of test substance: Not specified.
- Other information: eight different samples from each of the group number 90 were tested simultaneously on each panelist. The order of application was varied so that each test material occupied each of the possible positions with approximately equal frequency. Each patch is applied to the same area each time unless the severity of a reaction made this inadvisable. In such cases, subsequent application was made to an adjacent site or omitted. For the final challenge application duplicate patches were applied, one to the original site and one to a skin which had not previously received any patches.

EXAMINATIONS
- Reactions to the test materials were scored according to the following scale:
0: no evidence of irritation
1: slight erythema
2: marked erythema
III: scattered small petechial erosions and/or scabs
3: erythema and papules
E: edema; erythema may also be present
4: erythema, edema, and papules
5: strong reaction spreading beyond test site
Min: indicates minimal reaction for this grade definition

- Effects on superficial layers of the skin were scored as follows:
A: slight glazed appearance
B: marked glazing
C: glazing with peeling and cracking
F: glazing with deep fissures
G: numerous small scabs covering most or all of patch site

Results and discussion

Results of examinations:
SYMPTOMS
- Frequency, level, duration of symptoms observed: see 'Any other information on results incl. tables".

* Group 90, BP-10-11:
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects not sensitized: 20/22
- Number of subjects possibly sensitized: 2/22
- Number of subjects probably sensitized: 0/22
- Number of subjects with moderate or marked irritation: 0/22
- Number of subjects with little or none irritation: 22/22

RESULT OF CASE REPORT: Twenty-two panelists showed little or no primary irritation. Two panelists, Nos. 1 and 5, showed evidence of possible sensitization.

* Group 90, BP-10-11L:
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects not sensitized: 22/22
- Number of subjects possibly or probably sensitized: 0/22
- Number of subjects with marked irritation: 0/22
- Number of subjects with moderate irritation: 1/22
- Number of subjects with little or none irritation: 21/22

RESULT OF CASE REPORT: Twenty-one panelists showed little or no reaction. Panelists, No.5, showed moderate primary irritation. No evidence of sensitization was exhibited by the panelists.

Any other information on results incl. tables

Table 7.10.4/2: Individual scores following Patch Application of Group 90, BP-10-11

PANELIST

1

2

3

4

5

6

7

8

9

MU

O

A

O’

A’

1

0

0

-

*0

0

0

3Min

M

 

0

 

0

 

0

0

0

0

0

2

0

0

1C

1C

0

0

0

0

0

 

0

0

0

0

3

0

0

0

0

1

1

0

0

0

 

0

0

0

0

4

0

0

0

-

*0

1

1

1

0

 

0

0

0

0

5

0

0

1

1C

4

M

 

0

 

0

 

0

 

0

 

0

0

0

0

6

0

0

0

1C

0

-

*0

0

0

0

0

0

0

0

7

0

0

0

-

*0

0

0

0

0

0

0

0

0

0

8

0

1

M

 

0

 

0

 

1

 

2C

 

0

 

0

 

0

 

0

0

0

0

9

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

11

0

0

0

0

0

0

0

0

0

 

0

0

0

0

12

1B

0

0

0A

1C

1

2C

1C

2C

 

0

0

0

0

13

0

0

0

0

0

0

0

0C

0

 

0

0

0

0

14

0

0

0

0

0

0

0

0

0

 

0

0

0

0

15

0

0

0

0

0

1C

1C

2F

M

 

1

 

0

0

0

0

16

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

18

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

20

0

0

0

0

0A

0A

0

0

0

 

0

0

0

0

21

0

0

0

0

0

0

0

0

0

 

0

0

0

0

22

0

0

0

0

0

0

0

0

0

 

0

0

0

0

M: applied to an adjacent site after strong test reaction

-: panelist absent

*: residual reaction to earlier application, after an absence, not included in score totals

Table 7.10.4/3: Score Totals for All Panelists Following Application of Group 90, BP-10-11

TOTALS

1

2

3

4

5

6

7

8

9

MU

O

A

O’

A’

0

21

21

19

16

16

16

17

19

19

3

22

22

22

22

1

1

1

2

3

3

4

2

2

1

0

0

0

0

0

2

0

0

0

0

0

1

1

1

1

0

0

0

0

0

3

0

0

0

0

0

0

1

1

0

0

0

0

0

0

4

0

0

0

0

1

0

0

0

0

0

0

0

0

0

A

0

0

0

1

1

1

0

0

0

0

0

0

0

0

C

0

0

1

3

1

2

2

2

1

0

0

0

0

0

F

0

0

0

0

0

0

0

1

0

0

0

0

0

0

NP

0

0

1

3

2

1

1

0

1

0

0

0

0

0

NP: number of panelists not included in score total: (-, *)

Table 7.10.4/4: Individual scores following Patch Application of Group 90, BP-10-11L

PANELIST

1

2

3

4

5

6

7

8

9

MU

O

A

O’

A’

1

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

3

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

5

0

0

3

M

(2)

0

(2)

1

 

0

 

0

 

0

 

0

 

0

0

0

0

6

0

0

0

1C

0

-

*0

0

0

0

0

0

0

0

7

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

9

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

11

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

13

0

0

0

0

0

0

0

0

0

 

0

0

0

0

14

0

0

0

0

0

0C

0

0

0

 

0

0

0

0

15

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

17

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

19

0

0

0

0

0

0

0

0

0

 

0

0

0

0

20

0

0

0

0

0A

0A

0

0

0

 

0

0

0

0

21

0

0

0

0

0

0

0

0

0

 

0

0

0

0

22

0

0

0

0

0

0

0

0

0

 

0

0

0

0

M: applied to an adjacent site after strong test reaction

-: panelist absent

*: residual reaction to earlier application, after an absence, not included in score totals

( ): scores un ( ) are residual or flaring reactions on sites of earlier applications, recorded only when of special interest. Not included in score totals.

Table 7.10.4/5: Score Totals for All Panelists Following Application of Group 90, BP-10-11L

TOTALS

1

2

3

4

5

6

7

8

9

MU

O

A

O’

A’

0

22

22

20

18

19

21

21

22

21

3

22

22

22

22

1

0

0

0

1

1

0

0

0

0

0

0

0

0

0

3

0

0

1

0

0

0

0

0

0

0

0

0

0

0

A

0

0

0

0

1

1

0

0

0

0

0

0

0

0

C

0

0

0

1

0

1

0

0

0

0

0

0

0

0

NP

0

0

1

3

2

1

1

0

1

0

0

0

0

0

NP: number of panelists not included in score total: (-, *)

Applicant's summary and conclusion

Conclusions:
Under the conditions of the study, the test material can be considered as non-sensitizing.
Executive summary:

In a Human Repeated Insult Patch Test, the primary irritation and sensitization propoerties of the test sample was tested on 22 volunteers.

The procedure used was an adaptation of the method of Draize. Before application to the skin, 0.5 mL of the sample was applied to the Webril swatch by means of a calibrated dropper. The test patches were applied to the upper arms of the panelists, 3 times per week for 3 weeks. Eight different samples from the group number 90 were tested simultaneously on each panelist. The order of application was varied so that each test material occupied each of the possible positions with approximately equal frequency. The panelists were instructed to remove the patches 24 hours after application.

Each patch was applied to the same area each time unless the severity of a reaction made this inadvisable. In such cases, subsequent application was made to an adjacent site or omitted. For the final challenge application after a 2-week rest period, duplicate patches were applied, one to the original site and one to a skin which had not previously received any patches.

Reactions to the test material were scored after removal of each patch.

Results:

- group 90, BP-10-11: twenty-two panelists showed little or no primary irritation. Two panelists, Nos. 1 and 5, showed evidence of possible sensitization.

- group 90, BP-10-11L: Twenty-one panelists showed little or no reaction. Panelists, No.5, showed moderate primary irritation. No evidence of sensitization was exhibited by the panelists.

Under the test conditions, the test material tested undiluted can be considered as non-sensitizing.