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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Study period:
3 Mar - 26 Apr 1967
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented study report which meets basic scienific principles.

Data source

Referenceopen allclose all

Reference Type:
other: monthly report
Title:
Unnamed
Year:
1967
Report Date:
1967
Reference Type:
other: monthly report
Title:
Unnamed
Year:
1967
Report Date:
1967

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
The test substance was applied to the skin of 105 human volunteers under occlusive patches. For induction, the initial patches remained on the skin for 72 h whereas the challenge patches were removed after 48 h. Volunteers that showed a primary irritation after induction were further exposed to the test item under semi-occlusive patches. Beside the test substance, 5 additional chemicals were tested simultaneously on the same volunteers.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): only trade name given
- Analytical purity: no data
- Composition of test material, percentage of components: 87.5% [trade name], 6.5% Tween 20, 6.0% H2O
- Lot/batch No.: 5850

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 203
- Sex: 120 males, 83 females
- Age: 5 - 65
- Demographic information: white and coloured volunteers (females: 1 white and 5 coloured, males: 95 white and 4 coloured; not further specified)
Controls:
not required, untreated sites of the same volunteers served as control
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive and semiocclusive (for further details see "Any other information on materials and methods incl. tables")
- Description of patch:
occlusive patch: closed vinyl plastic patch ("Tech Tabs")
semi-occlusive patch: gauze patch held in place with adhesive tape (secured only above and below the gauze patch)
- Vehicle / solvent: none
- Concentrations: 100%

Results and discussion

Results of examinations:
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions:
Induction: 26 out of 203 volunteers
Challenge: 17 out of 203 volunteers
- Number of subjects with negative reactions:
Induction: 177
Challenge: 186
- Number of subjects with equivocal reactions:
Induction: 6
Challenge: 8
- Number of subjects with irritating reactions:
Induction: 20
Challenge: 9

OTHER RESULTS:
NO. OF PERSONS WITH/OUT REACTIONS AFTER SEMI-OCCLUSIVE PATCH
- Number of subjects with positive reactions:
After induction: 3 out of 21 volunteers
After challenge: 4 out of 26 volunteers
- Number of subjects with negative reactions:
After induction: 18
After challenge: 22
- Number of subjects with equivocal reactions:
After induction: not further specified
After challenge: 4
- Number of subjects with irritating reactions:
After induction: not further specified
After challenge: 0

Any other information on results incl. tables

Table 1: Skin reactions

Volunteer

Induction (occlusive)

Challenge (occlusive)

1

±

0

2

±

0

3

±

±

4

±

±

5

±

1+

6

±

1+

7

1+

0

8

1+

0

9

1+

0

10

1+

0

11

1+

0

12

1+

0

13

1+

0

14

1+

0

15

1+

0

16

1+

0

17

1+

±

18

1+

±

19

1+

1+

20

1+

2+

21

1+

3+

22

2+

±

23

2+

1+

24

2+

1+

25

2+

2+

26

3+

±

 

Applicant's summary and conclusion

Conclusions:
The test item induced a positive skin reaction after the induction period under occlusive patches in 26 volunteers with 14 of those showing a positive skin reaction after the challenge thereby suggesting the induction of a sensitisation reaction. However, when volunteers were re-exposed to the test item under semi-occlusive patches, only 3 or 4 volunteers showed a positive skin reaction after the first or second re-exposure, respectively. Thus, the type of application seems to have a strong impact on the skin reaction. Additionally, considering the fact that the test item induced only equivocal effects after re-exposure under semi-occlusive patches, the skin reactions seem to be related to mild skin irritation instead of sensitisation.