[1,3,8,16,18,24-hexabromo-2,4,9,10,11,15,17,22,23,25-decachloro-29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]copper

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro cytogenicity / chromosome aberration study in mammalian cells

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well documented study, which was conducted according to the Guideline for Screening Mutagenicity Testing of Chemicals (Japan).

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)

Principles of method if other than guideline:

A positive control (benzo(a)pyrene) was used, however, the results of the positive control were not listed.

GLP compliance:

not specified

Type of assay:

in vitro mammalian chromosome aberration test

Test material

Test material information

Constituent 1

Reference substance name:

29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper

EC Number:

205-685-1

EC Name:

29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper

Cas Number:

147-14-8

Molecular formula:

C32H16CuN8

IUPAC Name:

[29H,31H-phthalocyaninato(2-)-kappa~2~N~29~,N~31~]copper

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): Phtalocyanine Blue, Pigment Blue-15
- Analytical purity: technical grade

Method

Target gene:

The purpose of the in vitro chromosomal aberration test is to identify agents that cause structural chromosomal aberrations in cultured mammalian cells. Structural aberrations may be of two types, chromosome or chromatid.

Species / strain

Species / strain / cell type:

other: Chinese Hamster CHL cells

Metabolic activation:

with and without

Metabolic activation system:

S9 fraction from the liver of rats, treated with phenobarbital and 5,6-benzoflavone.

Test concentrations with justification for top dose:

0, 0.75, 1.5, 3 mg/ml with and without metabolic activation.

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

benzo(a)pyrene

Details on test system and experimental conditions:

A Chromosomal Aberration Assay was conducted according to the Guideline for Screening Mutagenicity Testing of Chemicals (Japan).
4 different experimental protocols were conducted, as recommended in the Japanese Guideline:
- Continuous treatment for 24 h without S9-mix (24/24 -S9).
- Continuous treatment for 48 h without S9-mix (24/24 -S9).
- Pulse treatment for 6 h without S9-mix followed by harvesting at 24 h (6/24 -S9).
- Pulse treatment for 6 h with S9-mix followed by harvesting at 24 h (6/24 +S9).

All chromosome aberrations observed (chromatid and chromosome gap, chromatid break, chromatid exchange, chromosome break, exchange) were recorded as number of the respective effect per 100 cells (equates to %).

Positive control: Benzo(a)pyren

Plates per dose: 1

Results and discussion

Test results

Species / strain:

mammalian cell line, other: Chinese Hamster CHL cells

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: with metabolic activation: > 3 mg/ml, without metabolic activation: > 3 mg/ml

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

not specified

Additional information on results:

None of dose groups induced any chromosomal aberrations or polyploidy in CHL cells with or without S9-mix.

Any other information on results incl. tables

Table 1: Results of Chromosomal Aberration test (continuous treatment for 24 h and 48 h without S9-mix):

	Treatment time (h)	Concentration (mg/ml)	Number of cells	Polyploid	No. of chromosomal aberrations						No. of cells with Chr. Ab. Incl. Gaps
					Chromatid type			Chromosome type		others
					g	ctb	cte	csb	cse
DMSO	24	0	100	1	1	0	0	0	0	0	1
	48	0	100	1	1	0	0	0	0	0	1
Test substance	24	0.75	100	1	1	0	0	0	0	0	1
	24	1.5	100	3	0	1	0	0	0	0	1
	24	3.0	100	2	1	0	0	0	0	0	1
	48	0.75	100	2	0	0	0	0	0	0	0
	48	1.5	100	1	1	1	0	0	0	0	2
	48	3.0	100	2	0	0	0	0	0	0	0

Table 2: Results of Chromosomal Aberration test (pulse treatment for 6 h with and without S9-mix followed by harvesting at 24 h):

	S9-mix	Concentration (mg/ml)	Number of cells	Polyploid	Chromosomal aberration (%)						Number of cells with Chr. Ab. Incl. Gaps
					Chromatid type			Chromosome type		others
					g	ctb	cte	csb	cse
DMSO	-	0	100	0	0	0	0	0	0	0	0
	+	0	100	0	1	0	0	0	0	0	0
Test substance	-	0.75	100	1	3	0	0	0	0	0	3
	-	1.5	100	0	0	0	0	0	0	0	0
	-	3.0	100	0	0	0	0	0	0	0	0
	+	0.75	100	0	0	0	0	0	0	0	0
	+	1.5	100	0	0	0	0	0	0	0	0
	+	3.0	100	2	0	0	0	1	0	0	1

Abbreviations in table 1 and table 2:

g = chromatid and chromosome gap

ctb = chromatid break

cte = chromatid exchange

csb = chromosome break

cse = exchange