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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: migrated information
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:
other: not specified (migrated information)
Justification for non-LLNA method:
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

Test material

Constituent 1
Reference substance name:
A mixture of: pentasodium 7-amino-3-[[4-[[4-[[4-[[4-[(6-amino-1-hydroxy-3-sulfonato-2-naphthyl)azo]7-sulfonato-1-naphthyl]azo]phenyl]amino]-3-sulfonatophenyl]azo]6-sulfonato-1-naphthyl]azo]-4-hydroxynaphthalen-2-sulfonate; a mixture of: pentasodium 7-amino-8-[4-[4-[4-[4-(2-amino-5-hydroxy-7-sulfonato-naphthalen-1-ylazo)-7-sulfonatonaphthalen-1-ylazo]-phenylamino]-3-sulfonato-phenylazo]-6-sulfonato-naphthalen-1-ylazo]-4-hydroxy-naphthalene-2-sulfonate and pentasodium 7-amino-8-[4-[4-[4-[4-(6-amino-1-hydroxy-3-sulfonato-naphthalen-1-ylazo)-7-sulfonatonaphthalen-1-ylazo]-phenylamino]-3-sulfonato-phenylazo]-6-sulfonato-naphthalen-1-ylazo]-4-hydroxy-naphthalene-2-sulfonate; tetrasodium 7-amino-4-hydroxy-3-[4-[4-[4-(4-hydroxy-7-sulfonato-naphthalen-1-ylazo)-2-sulfonato-phenylamino]phenylazo]-6-sulfonato-naphthalen-1-ylazo]naphthalene-2-sulfonate; tetrasodium 7-amino-4-hydroxy-3-[4-[4-[4-(4-amino-7-sulfonato-naphthalen-1-ylazo)-2-sulfonato-phenylamino]phenylazo]-6-sulfonato-naphthalen-1-ylazo]naphthalene-2-sulfonate
EC Number:
415-350-3
EC Name:
A mixture of: pentasodium 7-amino-3-[[4-[[4-[[4-[[4-[(6-amino-1-hydroxy-3-sulfonato-2-naphthyl)azo]7-sulfonato-1-naphthyl]azo]phenyl]amino]-3-sulfonatophenyl]azo]6-sulfonato-1-naphthyl]azo]-4-hydroxynaphthalen-2-sulfonate; a mixture of: pentasodium 7-amino-8-[4-[4-[4-[4-(2-amino-5-hydroxy-7-sulfonato-naphthalen-1-ylazo)-7-sulfonatonaphthalen-1-ylazo]-phenylamino]-3-sulfonato-phenylazo]-6-sulfonato-naphthalen-1-ylazo]-4-hydroxy-naphthalene-2-sulfonate and pentasodium 7-amino-8-[4-[4-[4-[4-(6-amino-1-hydroxy-3-sulfonato-naphthalen-1-ylazo)-7-sulfonatonaphthalen-1-ylazo]-phenylamino]-3-sulfonato-phenylazo]-6-sulfonato-naphthalen-1-ylazo]-4-hydroxy-naphthalene-2-sulfonate; tetrasodium 7-amino-4-hydroxy-3-[4-[4-[4-(4-hydroxy-7-sulfonato-naphthalen-1-ylazo)-2-sulfonato-phenylamino]phenylazo]-6-sulfonato-naphthalen-1-ylazo]naphthalene-2-sulfonate; tetrasodium 7-amino-4-hydroxy-3-[4-[4-[4-(4-amino-7-sulfonato-naphthalen-1-ylazo)-2-sulfonato-phenylamino]phenylazo]-6-sulfonato-naphthalen-1-ylazo]naphthalene-2-sulfonate
Molecular formula:
C52H32N11Na5O17S5
IUPAC Name:
A mixture of: pentasodium 7-amino-3-[[4-[[4-[[4-[[4-[(6-amino-1-hydroxy-3-sulfonato-2-naphthyl)azo]7-sulfonato-1-naphthyl]azo]phenyl]amino]-3-sulfonatophenyl]azo]6-sulfonato-1-naphthyl]azo]-4-hydroxynaphthalen-2-sulfonate; a mixture of: pentasodium 7-amino-8-[4-[4-[4-[4-(2-amino-5-hydroxy-7-sulfonato-naphthalen-1-ylazo)-7-sulfonatonaphthalen-1-ylazo]-phenylamino]-3-sulfonato-phenylazo]-6-sulfonato-naphthalen-1-ylazo]-4-hydroxy-naphthalene-2-sulfonate and pentasodium 7-amino-8-[4-[4-[4-[4-(6-amino-1-hydroxy-3-sulfonato-naphthalen-1-ylazo)-7-sulfonatonaphthalen-1-ylazo]-phenylamino]-3-sulfonato-phenylazo]-6-sulfonato-naphthalen-1-ylazo]-4-hydroxy-naphthalene-2-sulfonate; tetrasodium 7-amino-4-hydroxy-3-[4-[4-[4-(4-hydroxy-7-sulfonato-naphthalen-1-ylazo)-2-sulfonato-phenylamino]phenylazo]-6-sulfonato-naphthalen-1-ylazo]naphthalene-2-sulfonate; tetrasodium 7-amino-4-hydroxy-3-[4-[4-[4-(4-amino-7-sulfonato-naphthalen-1-ylazo)-2-sulfonato-phenylamino]phenylazo]-6-sulfonato-naphthalen-1-ylazo]naphthalene-2-sulfonate
Test material form:
solid: particulate/powder

In vivo test system

Test animals

Species:
other: albino guinea pig

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
%
No. with + reactions:
7
Total no. in group:
40
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0%
No. with + reactions:
0
Total no. in group:
40
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
1%
No. with + reactions:
2
Total no. in group:
40
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
40

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 1 %

Signs of irritation during induction:

During the induction phase no skin reactions on the guinea

pig skin were observed.

Evidence of sensitisation of each challenge concentration:

7 of 20 animals in the

Applicant's summary and conclusion

Interpretation of results:
other: not classified