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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Exposure related observations in humans: other data

Administrative data

Endpoint:
exposure-related observations in humans: other data
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 study / information:
Skin irritation in human.
Endpoint addressed:
skin irritation / corrosion
Principles of method if other than guideline:
Repeated Insult Patch Test.
GLP compliance:
no
Remarks:
Pre GLP.

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrasodium 4,4'-bis[[4-[(2-hydroxyethyl)amino]-6-(m-sulphonatoanilino)-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate
EC Number:
240-400-4
EC Name:
Tetrasodium 4,4'-bis[[4-[(2-hydroxyethyl)amino]-6-(m-sulphonatoanilino)-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate
Cas Number:
16324-27-9
Molecular formula:
C36H32N12Na4O14S4
IUPAC Name:
Tetrasodium 2,2'-[(E)-1,2-ethenediyl]bis[5-({4-[(2-hydroxyethyl)amino]-6-[(3-sulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)benzenesulfonate]

Method

Ethical approval:
not specified
Remarks:
Volunteers
Details on study design:
To determine if the test material is capable of irritating the skin of humans under controlled test conditions and, if so, to classify the test material as a primary irritant, fatiguing agent, and/or sensitizer on the basis of the visible clinical responses.
Details on exposure:
- N. Subjects: 50 Human Volunteers (29 children and 21 adults).
- Size of Patch: 3 cm x 3 cm (occluded)
- Density: 0.1 ml/9.0 sq. cm.

Results and discussion

Results:
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 reaction 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 irritating.
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.