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Toxicological information

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:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1992

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Qualifier:
according to guideline
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Version / remarks:
84/449/EEC, B14
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Phthalocyanine-N-[3-(diethylamino)propyl]sulfonamide copper complex
EC Number:
413-650-9
EC Name:
Phthalocyanine-N-[3-(diethylamino)propyl]sulfonamide copper complex
Cas Number:
93971-95-0
Molecular formula:
Can not be identified
IUPAC Name:
hexacopper(2+) 5-{[3-(diethylamino)propyl]sulfamoyl}-2,11,20,29,37,38,39,40-octaazanonacyclo[28.6.1.1^{3,10}.1^{12,19}.1^{21,28}.0^{4,9}.0^{13,18}.0^{22,27}.0^{31,36}]tetraconta-1,3(40),4,6,8,10,12,14,16,18,20,22,24,26,28(38),29,31,33,35-nonadecaene-37,39-diide 6,14-bis({[3-(diethylamino)propyl]sulfamoyl})-2,11,20,29,37,38,39,40-octaazanonacyclo[28.6.1.1^{3,10}.1^{12,19}.1^{21,28}.0^{4,9}.0^{13,18}.0^{22,27}.0^{31,36}]tetraconta-1,3(40),4,6,8,10,12,14,16,18,20,22,24,26,28(38),29,31,33,35-nonadecaene-37,39-diide 6,15-bis({[3-(diethylamino)propyl]sulfamoyl})-2,11,20,29,37,38,39,40-octaazanonacyclo[28.6.1.1^{3,10}.1^{12,19}.1^{21,28}.0^{4,9}.0^{13,18}.0^{22,27}.0^{31,36}]tetraconta-1,3(40),4,6,8,10,12,14,16,18,20,22,24,26,28(38),29,31,33,35-nonadecaene-37,39-diide 6-{[3-(diethylamino)propyl]sulfamoyl}-2,11,20,29,37,38,39,40-octaazanonacyclo[28.6.1.1^{3,10}.1^{12,19}.1^{21,28}.0^{4,9}.0^{13,18}.0^{22,27}.0^{31,36}]tetraconta-1,3(40),4,6,8,10,12,14,16,18,20,22,24,26,28(38),29,31,33,35-nonadecaene-37,39-diide 7-{[3-(diethylamino)propyl]sulfamoyl}-2,11,20,29,37,38,39,40-octaazanonacyclo[28.6.1.1^{3,10}.1^{12,19}.1^{21,28}.0^{4,9}.0^{13,18}.0^{22,27}.0^{31,36}]tetraconta-1,3(40),4,6,8,10,12,14,16,18,20,22,24,26,28(38),29,31,33,35-nonadecaene-37,39-diide 8-{[3-(diethylamino)propyl]sulfamoyl}-2,11,20,29,37,38,39,40-octaazanonacyclo[28.6.1.1^{3,10}.1^{12,19}.1^{21,28}.0^{4,9}.0^{13,18}.0^{22,27}.0^{31,36}]tetraconta-1,3(40),4,6,8,10,12,14,16,18,20,22,24,26,28(38),29,31,33,35-nonadecaene-37,39-diide
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Method

Species / strain
Species / strain / cell type:
bacteria, other: TA1535, TA100, TA1537, TA1538, TA98
Metabolic activation:
with and without
Metabolic activation system:
S9 prepared from the livers of male Sprague-Dawley rats. British Industrial Biological Research Association.
Test concentrations with justification for top dose:
Experiment 1 : Concentration range in the main test (with and metabolic activation): 8, 40, 200, 1000 and 5000 μg/plate
Experiment 2 : Concentration range in the main test (with and metabolic activation): 312.5, 625, 1250, 2500 and 5000 μg/plate
Vehicle / solvent:
Dimethyl sulphoxide
Details on test system and experimental conditions:
Negative control material : Dimethyl sulphoxide
Positive control materials :
N-Ethyl-N'-nitro-N-nitrosoguanidine (ENNG) 3 μg/plate for TA100 and 5 μg/plate for TA1535
9-aminoacridine (9AA) 80 μg/plate for TA1537
4-Nitro-O-phenylenediamine (4NOPD) 5 μg/plate for TA1538
4-Nitroquinoline-1-oxide (4NQO) 0.2 μg/plate for TA98
In addition the materials 2-Aminoanthracene (2AA) and Benzo(a)pyrene (BP)
which are non-mutagenic in the absence of metabolising enzymes were used
at the following concentrations in the S9 series of plates.
2AA at 2μg/plate for TA1535
BP at 5μg/plate for all of the other strains

The plates were incubated at 37℃ for approximately 48 hours.

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Species / strain:
other: TA1535, TA1537, TA1538, TA98 and TA100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: other: preliminary test
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation

The test material is found to be non-mutagenic under the conditions of this test.
Executive summary:

No significant increase in the numbers of revertant colonies was recorded for any of the bacterial strains with any dose of test material either with or without metabolic activation. Test material was found to be non-mutagenic under the conditions of this test.