Reaction products of copper phthalocyanine, sulfuric acid, and sodium carbonate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From September 26 to November 2, 2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Deviations:

not specified

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)

Deviations:

not specified

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Reaction products of copper phthalocyanine, sulfuric acid, and sodium carbonate

EC Number:

942-100-5

Molecular formula:

Not applicable: UVCB substance

IUPAC Name:

Reaction products of copper phthalocyanine, sulfuric acid, and sodium carbonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Method

Target gene:

Histidine locus

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

liver homogenate fraction (S9)

Test concentrations with justification for top dose:

Test Group - plate incorporation test:
a: without metabolic activation:
50, 160, 500, 1600 and 5000 µg /plate
b: with metabolic activation:
50, 160, 500, 1600 and 5000 µg /plate

Test Group - preincubation test (1):
a: without metabolic activation:
50, 160, 500, 1600 and 5000 µg /plate
b: with metabolic activation:
50, 160, 500, 1600 and 5000 µg /plate

Test Group - preincubation test (2):
a: without metabolic activation:
500, 1600, 2000, 3000, 4000 (with all the strains) and 5000 µg/plate (only with the strain TA 102)

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: deionized water

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene

Remarks:

With metabolic activation

Controls 2

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

2-nitrofluorene

sodium azide

mitomycin C

Remarks:

Without metabolic activation (S9-mix)

Details on test system and experimental conditions:

METHOD OF APPLICATION:
Plate incorporation test: in agar;
Preincubation test period only for the second test, if done.

DURATION
- Preincubation period (only for the second test, if done): 20 - 30 minutes at 30 °C

NUMBER OF REPLICATIONS:3

OTHER EXAMINATIONS:
- Sterility check: yes
- Solubility: yes
- Toxicity: Toxicity was assessed after microscopic thinning of the bacterial lawn and at least halving of the number of spontaneously occurring mutants compared to the corresponding solvent control value.

Evaluation criteria:

Criteria for a valid assay
The assay is considered valid if the following criteria are met:
- the solvent control data are within the laboratory's normal control range for the
spontaneous mutant frequency
- the positive controls induce increases in the mutation frequency which are significant
and within the laboratory's normal range

Criteria for a positive response
A test compound is classified as mutagenic if it has either of the following effects:
a) it produces at least a 2-fold increase in the mean number of revertants per plate of at least one of the tester strains over the mean number of revertants per plate of the appropriate vehicle control at complete bacterial background lawn
b) it induces a dose-related increase in the mean number of revertants per plate of at least one of the tester strains over the mean number of revertants per plate of the appropriate vehicle control in at least two to three concentrations of the test compound at complete bacterial background lawn.
If the test substance does not achieve either of the above criteria, it is considered to show no evidence of mutagenic activity in this system.

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: > 10 g/l
- Precipitation: Visible precipitation of the test compound on the plates was observed at 500 pg/plate and above in first preincubation test.

OTHER:
- In the preincubation test toxicity was only observed with the tester strain TA 1537 without metabolic activation at a concentration of 5000 pg/plate.
- Only in the preincubation test a slight increased number of revertants was obtained in the tester strain TA 102 in the absence of S9-mix. But in a following preincubation test this result was not confirmed.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Not mutagenic

Executive summary:

The substance to be registered has been tested according to OECD 471, EU Method B.13/14, EPA OPPTS 870.5100, and in compliance with the Good Laboratory Practice regulation. The strains used during the test were TA100, TA1535, TA 1537, TA98 and TA102. Two independent studies were conducted (one plate incorporation test and one preincubation test), each in absence and in presence of metabolic activation (S9 -mix). In the plate incorporation test the compound proved to be not toxic to the bacterial strains. In the preincubation test toxicity was only observed with the tester strain T1537 without metabolic activation at the concentration plate of 5000 µg/plate.

In the absence and in presence of the metabolic activation system the substance did not result in relevant increases in the number of revertants in any of the bacterial strain.