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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
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:
other: EC B.13 and B.14 (Ames test, Prival modification)
Principles of method if other than guideline:
gene mutation
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

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

Method

Species / strain
Species / strain / cell type:
bacteria, other: Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537, TA 1538; Escherichia coli WP2 uvr A
Metabolic activation system:
S9-Mix from syrian gold hamster
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 20 ... 2500 μg/plate
Concentration range in the main test (without metabolic activation): 20 ... 2500 μg/plate
Vehicle / solvent:
Solvent: 0,2 M phosphate buffer pH 7,4 water

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Additional information on results:
Observations:
From 39 ug/plate significant genemutation were observed (in the prival modification) with and without S9-mix in different bacteria strains. No toxicological effects occured.

Applicant's summary and conclusion

Conclusions:
positive with metabolic activation
positive without metabolic activation