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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
additional toxicological information
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From May 27, 1998 to June 26, 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: There are not desviations from the recommended guideline and it is GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Type of study / information:
To determine by repetitive epidermal contact the potential of a test material to induce primary or cumulative irritation and/or allergic contact sensitization.
Test guideline
Qualifier:
according to guideline
Guideline:
other: Human Repeat Insult Patch Test (HRIPT)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Details on test material:
Storage: Test material, unless otherwise specified, is stored at ambient temperature and humidity in the container(s) in which it is received.

TEST MATERIAL
Prior to the initiation of this study, the test material was prepared as a 0.5% dilution, using distilled water.
This procedure was conducted for each scheduled test day.

AMOUNT
approx. 0.2mL of diluted test material

PATCH SYSTEM
3/4 x 3/4 inch absorbant pad center fixed by non-porous adhesive dressing.
semi-occlusive adhesive dressing

Results and discussion

Any other information on results incl. tables

Induction Phase Virgin Challenge site
Subject Number 24*hr 1 2 3 4 5 6 7 8 9 24*hr 72hr
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 Did not complete study
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 Did not complete study
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 0 0 0 0 0 0 0 0 0 0
20 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
22 0 0 0 0 0 0 0 0 Did not complete study
23 Did not complete study
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
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
44 0 0 0 0 0 0 0 0 0 0 0 0
45 0 0 0 0 0 Did not complete study
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 0m 0 0 0 0
56 0   0 Did not complete study

24* : Supervised removal of 1st Induction and Challenge Patch

m : Additional maked day granted at the discretion of the clinical supervisor

Applicant's summary and conclusion

Conclusions:
Under the conditions of this study, test material, the product did not indicate a potencial for dermal irritation or allergic contact sensitization.
Executive summary:

To determine by repetitive epidermal contact the potencial of a test material to induce primary or cumulative irritation and/or allergic contact sensitization.

Under the conditions of this study, test material, the product did not indicate a potencial for dermal irritation or allergic contact sensitization.