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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
other: read across from analogue substance
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study has been presented to ECHA in the framework of a NONS notification. The document is now public because presented more than 12 years ago. The summary received is from migrated NONS dossier

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
study available

Test material

1
Chemical structure
Reference substance name:
Reaction mass of:pentasodium 7-amino-3-((E)-(4-((Z)-(4-(4-((E)-(4-((E)-(6-amino-1-hydroxy-3-sulfonatonaphthalen-2-yl)diazenyl)-7-sulfonato-5,8-dihydronaphthalen-1-yl)diazenyl)-2-sulfonatophenylamino)phenyl)diazenyl)-6-sulfonatonaphthalen-1-yl)diazenyl)-4-hydroxynaphthalene-2-sulfonate andpentasodium 7-amino-8-((E)-(4-((Z)-(4-(4-((E)-(4-((E)-(2-amino-5-hydroxy-7-sulfonatonaphthalen-1-yl)diazenyl)-7-sulfonato-5,8-dihydronaphthalen-1-yl)diazenyl)-2-sulfonatophenylamino)phenyl)diazenyl)-6-sulfonatonaphthalen-1-yl)diazenyl)-4-hydroxynaphthalene-2-sulfonate andpentasodium 7-amino-3-((E)-(4-((Z)-(4-(4-((E)-(4-((E)-(2-amino-5-hydroxy-7-sulfonatonaphthalen-1-yl)diazenyl)-7-sulfonato-5,8-dihydronaphthalen-1-yl)diazenyl)-2-sulfonatophenylamino)phenyl)diazenyl)-6-sulfonatonaphthalen-1-yl)diazenyl)-4-hydroxynaphthalene-2-sulfonate
EC Number:
940-364-6
Molecular formula:
C52H32N11Na5O17S5
IUPAC Name:
Reaction mass of:pentasodium 7-amino-3-((E)-(4-((Z)-(4-(4-((E)-(4-((E)-(6-amino-1-hydroxy-3-sulfonatonaphthalen-2-yl)diazenyl)-7-sulfonato-5,8-dihydronaphthalen-1-yl)diazenyl)-2-sulfonatophenylamino)phenyl)diazenyl)-6-sulfonatonaphthalen-1-yl)diazenyl)-4-hydroxynaphthalene-2-sulfonate andpentasodium 7-amino-8-((E)-(4-((Z)-(4-(4-((E)-(4-((E)-(2-amino-5-hydroxy-7-sulfonatonaphthalen-1-yl)diazenyl)-7-sulfonato-5,8-dihydronaphthalen-1-yl)diazenyl)-2-sulfonatophenylamino)phenyl)diazenyl)-6-sulfonatonaphthalen-1-yl)diazenyl)-4-hydroxynaphthalene-2-sulfonate andpentasodium 7-amino-3-((E)-(4-((Z)-(4-(4-((E)-(4-((E)-(2-amino-5-hydroxy-7-sulfonatonaphthalen-1-yl)diazenyl)-7-sulfonato-5,8-dihydronaphthalen-1-yl)diazenyl)-2-sulfonatophenylamino)phenyl)diazenyl)-6-sulfonatonaphthalen-1-yl)diazenyl)-4-hydroxynaphthalene-2-sulfonate

In vivo test system

Test animals

Species:
other: albino guinea pig

Study design: in vivo (non-LLNA)

Induction
Concentration / amount:
Concentration of the test material used at induction:
a) intracutaneous: 1 g/100 ml water p.l.
b) epicutaneous: 1g/100 ml water p.l.

Concentration of test material and vehicle used for challenge:
epicutaneous: 1 g/100 ml water p.l.
Challenge
Concentration / amount:
Concentration of the test material used at induction:
a) intracutaneous: 1 g/100 ml water p.l.
b) epicutaneous: 1g/100 ml water p.l.

Concentration of test material and vehicle used for challenge:
epicutaneous: 1 g/100 ml water p.l.
No. of animals per dose:
Number of animals in test group: 40
Number of animals in negative control group: 40

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1%
No. with + reactions:
7
Total no. in group:
40
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. + reactions: 7.0. Total no. in groups: 40.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0%
No. with + reactions:
0
Total no. in group:
40
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 40.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
1%
No. with + reactions:
2
Total no. in group:
40
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1%. No with. + reactions: 2.0. Total no. in groups: 40.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
40
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 40.0.

Any other information on results incl. tables

Maximu concentration not causing irritating effects in preliminart test: 1%

Sign of irritation during induction: no skin reactions on the guinea pig skin were observed

Evidence of sensitisation of each challenge concentration: 7 of 20 animals in the test gropup and 2 of 20 animals in the negative control group

Applicant's summary and conclusion

Interpretation of results:
other: not classified under Regulation 1272/2008
Remarks:
Migrated information