Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test procedures cannot be subsumed under testing guideline today scheduled by the REACH Regulation, nevertheless they followed accepted methods, are well documented and scientifically acceptable.

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:
Repeated Insult Patch Test.
GLP compliance:
no
Remarks:
Pre GLP.

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 50 human volunteers.
- Age: 29 children and 21 adults.
Route of administration:
dermal
Details on study design:
TYPE OF TEST USED: patch test (epicutaneous test).

ADMINISTRATION
- Type of application: occlusive.
- Patch: 3 cm x 3 cm.
- Concentrations: 0.1 ml/9.0 sq. cm.

Results and discussion

Results of examinations:
Skin changes accompanying application N. 1 Through 10: no visible skin changes signifying reaction to injury were observed in any of the subjects.
Skin changes accompanying application N. 11 Through 15: visible skin changes signifying reactions to injury were observed in three of the subjects.
Skin changes accompanying challenge application: visible skin changes signifying reactions to injury were observed in one of the subjects.
Skin changes accompanying second challenge application: this rechallenge was performed 10 -12 weeks after the first challenge on the one subject who reacted to the first challenge. No responses were noted as a result of this application.

Any other information on results incl. tables

SUMMARY OF REACTIONS GRADES*

Number of subjects negative: 47

Number of subjects showing reaction: 3

Number of subjects showing l+ but no higher: 0

Number of subjects showing 2+ but no higher: 0

Number of subjects showillg 3+ but no higher: 2

Number of subjects showing 4+ but no higher: 1

N. of application N. subjects N. of reactrions in grades indicated
Patched Not patched 0 1+ 2+ 3+ 4+
1 50 0 50 0 0 0 0
2 50 0 50 0 0 0 0
3 50 0 50 0 0 0 0
4 50 0 50 0 0 0 0
5 50 0 50 0 0 0 0
6 50 0 50 0 0 0 0
7 50 0 50 0 0 0 0
8 50 0 50 0 0 0 0
9 50 0 50 0 0 0 0
10 50 0 50 0 0 0 0
11 50 0 50 0 0 0 0
12 50 0 47 0 1 1 1
13 48 2 47 0 0 0 0
14 47 3 47 0 0 0 0
15 47 3 47 0 0 0 0
Challenge 50 0 49 0 1 0 0
Rechallenge 1 49 1 0 0 0 0

*Scoring criteria

0: No reaction

1 +: Slight erythema

2 +: Marked erythema

3 +: Marked erythema, oedema, with or without a few vesicles.

4 +: Marked erythema, oedema, with vesicles and oozing

Individual reactions

Subject number Exposure number
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 C
1 0 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 0
3 0 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 0
5 0 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 0
7 0 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 0
9 0 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 0
11 0 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 0
13 0 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 0
15 0 0 0 0 0 0 0 0 0 0 0 4+ NP NP NP 2+
16 0 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 0
18 0 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 0
20 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
21 0 0 0 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 0 0 0
23 0 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 0
25 0 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 0
27 0 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 0
29 0 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 0
31 0 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 0
33 0 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 0
35 0 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 0
37 0 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 2+ 3+ NP NP 0
39 0 0 0 0 0 0 0 0 0 0 0 3+ NP NP NP 0
40 0 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 0
42 0 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 0
44 0 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 0
46 0 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 0
48 0 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 0
50 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

Underlined entries denote change of site from previous application.

NP: No Patch applied

Applicant's summary and conclusion

Conclusions:
Not sensitising.
Executive summary:

Method

To determine if the test material is capable of irritating the skin of humans under controlled test conditions a repeated Insult Patch Test was performed on 50 human volunteers. 0.1 ml/9.0 sq. cm was applied under completely occluded conditions.

Results

Under completely occluded conditions test item was capable of causing irritations whose clinical course was more typical of a fatiguing mechanism than of a hypersensitivity in 3/50 subjects.