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Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: guideline study; restriction: non-GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Hydrogen [tris[[[3-[(2-ethylhexyl)oxy]propyl]amino]sulphonyl]-29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cuprate(1-), compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)
EC Number:
304-661-9
EC Name:
Hydrogen [tris[[[3-[(2-ethylhexyl)oxy]propyl]amino]sulphonyl]-29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cuprate(1-), compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)
Cas Number:
94277-77-7
Molecular formula:
C65 H84 Cu N11 O12 S4 .C11 H25 N O .H
IUPAC Name:
hydrogen [tris[[[3-[(2-ethylhexyl)oxy]propyl]amino]sulphonyl]-29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cuprate(1-), compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)
Details on test material:
Name of the test substance used in the study report: Neozapon Blau 807 Typ neu
Purity: ca. 100%

Method

Target gene:
S. typhimurium and E. coli
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Metabolic activation system:
Aroclor-induced rat liver S-9 mix
Test concentrations with justification for top dose:
20 ug - 5000 ug/plate (Standard Plate Test = SPT)
4 ug - 2500 ug/plate (Preincubation Test = PIT)
Vehicle / solvent:
Due to the limited solubility of the test substance in water, DMSO was selected as the vehicle, which had been demonstrated to be suitable in bacterial reverse mutation tests and for which historical control data are available.
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
yes
Positive controls:
yes
Positive control substance:
other: with metabolic activation: 2-aminoanthracene; without metabolic activation: N-methyl-N'-nitro-N-nitrosoguanidine, 4-nitro-o-phenylendiamine, 9-aminoacridine and 4-nitroquinoline-N-oxide
Details on test system and experimental conditions:
Standard Plate Test and Preincubation Test

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: A weak bacteriotoxic effect was observed under all test conditions.
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
An increase in the number of his+ or trp+ revertants was not observed in the standard plate test or in the preincubation test either withaut S-9 mix or after the addition of a metabolizing system.
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Accarding to the results of the present study, the test substance Neozapon Blau 807 Typ neu is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay under the experimental cond itions chosen here.

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