Registration Dossier

Toxicological information

Sensitisation data (human)

Currently viewing:

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2006
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Good Clinical Practice Study conducted according to acceptable scientific conditions. Number of voluntaries, applied dose, observation time and observed parameters are acceptable. Substance identification available from supplier for commercial name but no substance analytical certificate available in the report.
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Cross-reference
Reason / purpose:
read-across: supporting information
Reference
Endpoint:
sensitisation data (humans)
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
2006
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Good Clinical Practice Study conducted according to acceptable scientific conditions. Number of voluntaries, applied dose, observation time and observed parameters are acceptable. Substance identification available from supplier for commercial name but no substance analytical certificate available in the report.
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Reason / purpose:
read-across source
Type of sensitisation studied:
skin
Study type:
study with volunteers
Qualifier:
no guideline available
Principles of method if other than guideline:
The study was conducted in order to determine the dermal irritation and sensitization potential of a test material diluted to 10% with petrolatum. Semi-occlusive patches was applied to skin for a period of 24 hours. After 9 applications during the Induction Period the sites were graded by a CRL technician for dermal irritation. Following a 2-week rest period, the challenge patches were applied to previously untreated test sites on the back. After 24 hours, the patches were removed by a CRL technician and the test sites were evaluated for dermal reactions. The test sites were re-evaluated at 48 and 72 hours.
GLP compliance:
yes
Type of population:
general
Ethical approval:
confirmed and informed consent free of coercion received
Subjects:
- Number of subjects exposed: 56
- Sex: male and female
- Age: between 18 and 70
- Demographic information: see table 7.10.4/1
- Subjects willing to sign an Informed Consent Form in conformance with 21 CFR Part 50: "Protection of Human Subjects"
- Subjects who have completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164
- Subjects who demonstrate dependability and intelligence in following directions

Clinical history:
- Subjects who have completed a Panelist Profile/Medical History
- Subjects who are in general good health as determined by a Panelist Profile/Medical History
- Females who are not pregnant or lactating
- Subjects who are not currently using any systemic or topical corticosteroids, anti-inflammatory drugs or antihistamines
- Subjects who do not exhibit any skin diseases that might be confused with a skin reaction from the test material
Controls:
no data
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: semiocclusive Strip (TruMed Technoloies Inc., Burnsville, Minnesota)
- Vehicle / solvent: dilue to 10% with petrolum
- Skin preparation: wiped with 70% isopropyl alcohol and allowed to dry
- Description of patch: applied in the upper back between the scapula
- Testing/scoring schedule:
Substance was allowed to remain in direct skin contact for a period of 24 hours. Patches were applied to the same site on Monday, Wednesday, and Friday for a total of 9 applications during the Induction Period. This schedule may have been modified to allow for missed visits or holidays. If a subject was unable to report on an assigned test date, the test material was applied on 2 consecutive days during the Induction Phase and/or a makeup day was added at the end of the Induction Phase.

EXAMINATIONS
- Grading/Scoring system:
The sites were graded by a CRL technician for dermal irritation 24 hours after removal of the patches by the subjects on Tuesday and Thursday and 48 hours after removal of the patches on Saturday, unless the patching schedule was altered as described above.

The sites were graded according to a scoring system, Dermal Scoring Scale, as follows:

0 No visible skin reaction
f Barely perceptible erythema
1+ Mild erythema
2+ Well defined erythema
3+ Erythema and edema
4+ Erythema and edema with vesiculation

If a "2+" reaction or greater occurred on the new site, the subject was not patched again during the Induction Phase but was challenged on the appropriate day of the study. At the discretion of the Study Director, patch sites with scores less than a "2+" may have been changed.

Following approximately a 2-week rest period, the challenge patches were applied to previously untreated test sites on the back. After 24 hours, the patches were removed by a CRL technician and the test sites were evaluated for dermal reactions. The test sites were re-evaluated at 48 and 72 hours. Subjects exhibiting reactions during the Challenge Phase of the study may have been asked to return for a 96-hour reading.
Results of examinations:
This study was initiated with 56 subjects. Three subjects discontinued study participation for reasons unrelated to the test material. A total of 53 subjects completed the study.
Globally no visible skin reaction was observed.
Individual dermal scores recorded during the Induction and Challenge Phases appear in Table 1 (below).

Table 1 : Summary of Dermal Scores / Test Material: Gem Sea125 Lot 20060466

Subject Number

Induction Scores

Challenge Scores

1

2

3

4

5

6

7

8

9

24 Hour

48 Hour

72 Hour

1

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

3

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

0

0

0

0

0

0

0

0

0

0

6

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

8

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

10

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

12

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

14

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

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

18

0

0

0

0

0

0

0

0

0

0

0

0

19

0

0

Discontinued

20

0

0

Discontinued

21

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

23

0

0

Discontinued

24

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

26

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

28

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

30

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

32

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

34

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

36

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

38

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

40

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

42

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

44

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

46

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

48

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

50

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

52

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

54

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

56

0

0

0

0

0

0

0

0

0

0

0

0

Conclusions:
Based on the test population of 53 subjects and under the conditions of this study, Gem Seal 25 did not demonstrate any potential for eliciting dermal irritation or sensitization.
Executive summary:

The study was conducted in order to determine the dermal irritation and the sensitisation potential of Gem Seal 25 in 53 volunteers. The test substance was diluted at 10% in petrolatum. Semi-occlusive patches were applied to skin of volunteers for a period of 24 hours. Prior to the application, the test area was wiped with 70% isopropyl alcohol and allowed to dry. After 9 applications during the induction period the sites were graded for dermal irritation. Following a 2-week rest period, the challenge patches were applied to previously untreated test sites on the back. After 24 hours, the patches were removed and the test sites were evaluated for dermal reactions. The test sites were re-evaluated at 48 and 72 hours. No skin reaction was observed in any subjects.

Under the study conditions, Gem Seal 25 did not demonstrate a potential for eliciting dermal irritation or sensitization.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
The study was conducted in order to determine the dermal irritation and sensitization potential of a test material diluted to 10% with petrolatum. Semi-occlusive patches was applied to skin for a period of 24 hours. After 9 applications during the Induction Period the sites were graded by a CRL technician for dermal irritation. Following a 2-week rest period, the challenge patches were applied to previously untreated test sites on the back. After 24 hours, the patches were removed by a CRL technician and the test sites were evaluated for dermal reactions. The test sites were re-evaluated at 48 and 72 hours.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name (as cited in the report) : Gem Seal 25 Lot 20060466
- Substance type: petroleum product, UVCB
- Analytical purity: 100% Commercial product
- Composition of test material, percentage of components: hydrocarbons, C14-C18, n-alkanes, isoalkanes, cyclics, <2%aromatics
- Lot/batch No.: 20060466
- other: Test materials and all original forms of this study will be retained by Clinical Research Laboratories, Inc. as specified in CRL Standard Operating Procedure 30.6C, unless designated otherwise by the Sponsor.

Method

Type of population:
general
Ethical approval:
confirmed and informed consent free of coercion received
Subjects:
- Number of subjects exposed: 56
- Sex: male and female
- Age: between 18 and 70
- Demographic information: see table 7.10.4/1
- Subjects willing to sign an Informed Consent Form in conformance with 21 CFR Part 50: "Protection of Human Subjects"
- Subjects who have completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164
- Subjects who demonstrate dependability and intelligence in following directions

Clinical history:
- Subjects who have completed a Panelist Profile/Medical History
- Subjects who are in general good health as determined by a Panelist Profile/Medical History
- Females who are not pregnant or lactating
- Subjects who are not currently using any systemic or topical corticosteroids, anti-inflammatory drugs or antihistamines
- Subjects who do not exhibit any skin diseases that might be confused with a skin reaction from the test material
Controls:
no data
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: semiocclusive Strip (TruMed Technoloies Inc., Burnsville, Minnesota)
- Vehicle / solvent: dilue to 10% with petrolum
- Skin preparation: wiped with 70% isopropyl alcohol and allowed to dry
- Description of patch: applied in the upper back between the scapula
- Testing/scoring schedule:
Substance was allowed to remain in direct skin contact for a period of 24 hours. Patches were applied to the same site on Monday, Wednesday, and Friday for a total of 9 applications during the Induction Period. This schedule may have been modified to allow for missed visits or holidays. If a subject was unable to report on an assigned test date, the test material was applied on 2 consecutive days during the Induction Phase and/or a makeup day was added at the end of the Induction Phase.

EXAMINATIONS
- Grading/Scoring system:
The sites were graded by a CRL technician for dermal irritation 24 hours after removal of the patches by the subjects on Tuesday and Thursday and 48 hours after removal of the patches on Saturday, unless the patching schedule was altered as described above.

The sites were graded according to a scoring system, Dermal Scoring Scale, as follows:

0 No visible skin reaction
f Barely perceptible erythema
1+ Mild erythema
2+ Well defined erythema
3+ Erythema and edema
4+ Erythema and edema with vesiculation

If a "2+" reaction or greater occurred on the new site, the subject was not patched again during the Induction Phase but was challenged on the appropriate day of the study. At the discretion of the Study Director, patch sites with scores less than a "2+" may have been changed.

Following approximately a 2-week rest period, the challenge patches were applied to previously untreated test sites on the back. After 24 hours, the patches were removed by a CRL technician and the test sites were evaluated for dermal reactions. The test sites were re-evaluated at 48 and 72 hours. Subjects exhibiting reactions during the Challenge Phase of the study may have been asked to return for a 96-hour reading.

Results and discussion

Results of examinations:
This study was initiated with 56 subjects. Three subjects discontinued study participation for reasons unrelated to the test material. A total of 53 subjects completed the study.
Globally no visible skin reaction was observed.
Individual dermal scores recorded during the Induction and Challenge Phases appear in Table 1 (below).

Any other information on results incl. tables

Table 1 : Summary of Dermal Scores / Test Material: Gem Sea125 Lot 20060466

Subject Number

Induction Scores

Challenge Scores

1

2

3

4

5

6

7

8

9

24 Hour

48 Hour

72 Hour

1

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

3

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

0

0

0

0

0

0

0

0

0

0

6

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

8

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

10

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

12

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

14

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

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

18

0

0

0

0

0

0

0

0

0

0

0

0

19

0

0

Discontinued

20

0

0

Discontinued

21

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

23

0

0

Discontinued

24

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

26

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

28

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

30

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

32

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

34

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

36

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

38

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

40

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

42

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

44

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

46

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

48

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

50

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

52

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

54

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

56

0

0

0

0

0

0

0

0

0

0

0

0

Applicant's summary and conclusion

Conclusions:
Based on the test population of 53 subjects and under the conditions of this study, Gem Seal 25 did not demonstrate any potential for eliciting dermal irritation or sensitization.
Executive summary:

The study was conducted in order to determine the dermal irritation and the sensitisation potential of Gem Seal 25 in 53 volunteers. The test substance was diluted at 10% in petrolatum. Semi-occlusive patches were applied to skin of volunteers for a period of 24 hours. Prior to the application, the test area was wiped with 70% isopropyl alcohol and allowed to dry. After 9 applications during the induction period the sites were graded for dermal irritation. Following a 2-week rest period, the challenge patches were applied to previously untreated test sites on the back. After 24 hours, the patches were removed and the test sites were evaluated for dermal reactions. The test sites were re-evaluated at 48 and 72 hours. No skin reaction was observed in any subjects.

Under the study conditions, Gem Seal 25 did not demonstrate a potential for eliciting dermal irritation or sensitization.