Low chlorinated copper, [29H,31Hphthalocyaninato(2-)-N29,N30,N31,N32]-, wherein the number of chlorines is more than or equal to 0 and less than or equal to 5.

Genetic toxicity: in vitro

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

Study period:

1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Details on test material:

- Substance type: dark blue powder
- Physical state: solid
- Impurities (identity and concentrations): moisture and water soluble matter < 1 %

Specific details on test material used for the study:

-Test item name: Blue 10 GN
- Other name in report: Copper, [29H, 31H-phthalocyaninato-(2-)-N29, N30 , N31 , N32]-chlorinated (n=8-13)
- CAS 68987-63-3
-Batch no. 21993
-Purity: 99%
-Description: blue powder
-Storage conditions: Room temperature

Method

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:

liver S9 mix from rats treated with Arochlor 1254

Test concentrations with justification for top dose:

0, 312.5, 625, 1250, 2500 and 5000 μg/plate

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

4-nitroquinoline-N-oxide

9-aminoacridine

N-ethyl-N-nitro-N-nitrosoguanidine

benzo(a)pyrene

other: 2-Aminoanthracene

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

Evaluation criteria:

For a substance to be considered positive in this test system, it should
have induced a dose-related and statistically(S) significant increase in
mutation rate (of at least twice the spontaneous reversion rate) in one
or more strains of bacteria in the presence and/or absence of the 59
microsomal enzymes in both experiments at sub-toxic dose levels. If the
two experiments give conflicting results then a third experiment may be
used to confir~· the correct response. Tob~ considered negative the
number of .induced revertants compared to spontaneous revertants should
be less than twofold at each dose level amployed, the intervals of which
should be between 2 and 5 fold and extend to the limits imposed by
toxicity or solubility or up to the maximum recommended dose of 5000
μg/plate. In this case the limiting factor was the maximum recommended
dose.

Statistics:

not needed

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:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

No toxicity was exhibited to any of the strains of bacteria used. A precipitate was observed at and above 2500 μg/plate, this did not interfere
with the scoring of revertant colonies.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Experiment 1, without S9 mix
Test substance concentration per plate	TA100		TA1535		WP2uvrA·		TA98		TA1537
0	103	_(113)	19	(17)	24	(34)	22	(22)	1 1	(14)
	129		12		40		19		1 5
	108	13.8	20	4.4	37	8.5	25	3.0	15	2.3
8	106 94	(104)	11 20	(1 5)	34 41	(37)	16 20	(16)	1 3 13	(14)
	113	9.6	1 5	4.5	37	3.5	1 1	4.5	16	1.7
40	117 104	(108)	17 16	(15)	38 41	(38)	25 19	(21 )	9 1 1	(10)
	102	8.1	13	2.1	34	3.5	19	3.5	1 1	1.2
200	123 1 12	(110)	20 13	(15)	50 28	(40)	1 5 17	(18)	1 5 12	(14)
	95	14.1	13		42	11.1	22	3.6	16	2.1
1000	107	(105)	11	(10)	32	(30)	22	(21 )	16	(13)
	1 10		6		28		24		13
	98	6-2	13	3.6	29	2.1	16	4.2	9	3.5
5000	99P 124P	(107)	13P 13P	(14)	25P 24P	(28)	13P 19P	(17)	8P 1 1p	(10)
	99P	14.4	17P	2.3	36P	6.7	19P	3.5	1 2P	2.1
Positive control	ENNG		ENNG		ENNG		4NQO		9AA
Concentration (ug/plate)	3		5		2		0.2		80
	579		197		203		142		416
	594	(550)	173	(182)	190	(192)	123	(132)	342	(378)
	476	64.2	176	13.1	184	9.7	130	9.6	375	37.1

P = precipitation

Applicant's summary and conclusion

Conclusions:

non mutagenic in the Ames test