Pigment green No.7

ピグメントグリーンNo.7

　

[CAS No. 1328-53-6]

Molecular formula: C32Cl16CuN8｡｡Molecular weight: 1127.19

ABSTRACT

Pigment green No.7 was studied for oral toxicity in rats of both sexes in a single dose toxicity test at doses of 0 and 2000 mg/kg. The single dose toxicity test revealed an LD50 value of more than 2000 mg/kg for both sexes.

Pigment green No.7 was studied for oral toxicity in rats in a 28-day repeated dose toxicity test at doses of 0, 100, 300 and 1000 mg/kg. No effects of pigment green No.7 were detected with any observations, measurements or examination in each sex. No deaths occurred in either sex.

The NOEL for repeat dose toxicity is considered to be 1000 mg/kg/day for both sexes.

Pigment green No.7 was not mutagenic in Salmonella typhimurium TA100, TA1535, TA98, TA1537 and Escherichia coli WP2 uvrA, with or without an exogenous metabolic activation system.

Pigment green No.7 did not induce structural chromosomal aberrations or polyploidy in CHL/IU cells with or without exogenous metabolic activation.

SUMMARIZED DATA FROM THE STUDIES

1. Single Dose Oral Toxicity 1)

Purity : 99.1 wt%
Test species/strain : Rat/Crj:CD(SD)
Test method : OECD Test Guideline 401
｡｡Route : Oral(gavage)
｡｡Doses : 0, 2000 mg/kg
｡｡Number of animals/group : Males, 5; females, 5
｡｡Vehicle : Corn oil
GLP : Yes

｡｡Test results:

No deaths occurred in either sex during the observation period. Abnormalities of general condition were not observed in any males or females during the observation period.

The LD50 values were estimated to be more than 2000 mg/kg for both sexes.

2. Repeat Dose Toxicity 1)

Purity : 99.1 %
Test species/strain : Rats/Crj:CD(SD)IGS
Test method
　		 :
　		 Guideline for 28-Day Repeated Dose Toxicity Test in Mammalian Species (Chemical Substances Control Law of Japan)
｡｡Route : Oral
｡｡Doses : 0(vehicle), 100, 300, 1000 mg/kg/day
｡｡Number of animals/group : Males, 5; females, 5
｡｡Vehicle : Corn oil
｡｡Administration period : Males and females, 28 days
｡｡Terminal kill : Males and females, days 29 and 43
GLP : Yes

｡｡Test results:

No effects of pigment green No.7 were detected in terms of general condition, body weights, food consumption, hematological or blood chemistry parameters, urinalysis, organ weights, or pathological examination in males or females. No deaths occurred in either sex.

The NOEL for repeat dose toxicity is considered to be 1000 mg/kg/day for both sexes.

3. Genetic Toxicity

3-1. Bacterial test 2)

Purity : 99.1 %
Test species/strain : Salmonella typhimurium TA100, TA1535, TA98, TA1537, Escherichia coli WP2 uvrA
Test method
　		 :
　		 Guidelines for Screening Mutagenicity Testing of Chemicals(Chemical Substances Control Law of Japan) and OECD Test Guideline 471
｡｡Procedures : Pre-incubation method
｡｡Solvent : DMSO
｡｡Positive controls


　		 :


　		 -S9 mix; 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide (TA100, TA98), Sodium azide (TA1535), 9-Aminoacridine (TA1537) and N-Ethyl-N'-nitro-N-nitrosoguanidine (WP2 uvrA)
+S9 mix; 2-Aminoanthracene(all strains)
｡｡Doses




　		 :




　		 -S9 mix; 9.77, 19.5, 39.1, 78.1, 156, 313 and 625 ｦﾌg/plate(TA100, TA1535, TA98 and TA1537)
-S9 mix; 313, 625, 1250, 2500 and 5000 ｦﾌg/plate(WP2 uvrA)
+S9 mix; 156, 313, 625, 1250, 2500 and 5000 ｦﾌg/plate
(TA100, TA1535, TA98 and TA1537)
+S9 mix; 313, 625, 1250, 2500 and 5000 ｦﾌg/plate(WP2 uvrA)
｡｡S9 : Rat liver, induced with phenobarbital and 5,6-benzoflavone
｡｡Plates/test : 3
｡｡Number of replicates : 2
GLP : Yes

｡｡Test results:

This chemical did not induce gene mutations in the Salmonella typhimurium and Escherichia coli strains. Toxicity was observed at 313 ｦﾌg/plate or more (TA100 and TA1535)and at 625 ｦﾌg/plate (TA98 and TA1537) without metabolic activation, and at 5000 ｦﾌg/plate(TA100, TA1535, TA98 and TA1537) with metabolic activation.

Genetic effects:
Salmonella typhimurium TA100, TA1535, TA98 and TA1537

　 + ? -
Without metabolic activation: [ ] [ ] [*]
With metabolic activation: [ ] [ ] [*]

Escherichia coli WP2 uvrA

　 + ? -
Without metabolic activation: [ ] [ ] [*]
With metabolic activation: [ ] [ ] [*]

3-2. Non-bacterial in vitro test (chromosomal aberration test)2)

Purity : 99.1 %
Type of cell used : Chinese hamster CHL/IU cells
Test method
　		 :
　		 Guidelines for Screening Mutagenicity Testing of Chemicals(Chemical Substances Control Law of Japan) and OECD Test Guideline 473
｡｡Solvent : Dimethylsulfoxide
｡｡Positive controls
　		 :
　		 -S9 mix; Mitomycin C
+S9 mix; Benzo[a]pyrene
｡｡Doses

　		 :

　		 -S9 mix(6 hr short-term treatment); 0, 125, 250, 500 ｦﾌg/mL
+S9 mix(6 hr short-term treatment); 0, 125, 250, 500 ｦﾌg/mL
-S9 mix(24 hr continuous treatment); 0, 125, 250, 500 ｦﾌg/mL
｡｡S9 : Rat liver, induced with phenobarbital and 5,6-benzoflavone
｡｡Plates/test : 2
GLP : Yes

｡｡Test results:

This chemical did not induce structural chromosomal aberrations or polyploidy under the conditions of this experiment.

Genotoxic effects:

　 clastogenicity polyploidy
　 + ? - + ? -
Without metabolic activation: [ ] [ ] [*] [ ] [ ] [*]
With metabolic activation: [ ] [ ] [*] [ ] [ ] [*]
1)

　		 The tests were performed by the Biosafety Research Center, Foods, Drugs and Pesticides(An-pyo Center), Japan, 582-2 Arahama, Shioshinden, Fukude-cho, Iwata-gun, Shizuoka, 437-1213, Japan. Tel +81-538-58-1266 Fax +81-538-58-1393
2)
　		 The tests were performed by the Mitsubishi Chemical Safety Institute Ltd., 14 Sunayama, Hasaki-machi, Kashima-gun, Ibaraki 314-0255, Japan. Tel +81-479-46-2871 Fax +81-479-46-2874