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Description of key information

Pigment Green 7 did not cause adverse effects at the limit dose in subacute gavage and subchronic feeding studies.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Valid experimental data were available to assess the toxicity of the tested material after repeated administration of Pigment Green 7

A GLP-compliant 28 day subacute study was conducted, according to the Japanese guideline for 28 Day Repeated Dose Toxicity Test of Chemicals with Wistar rats, which received 0, 100, 300 and 1000 mg/kg/day polychloro copper phthalocyanine by gavage using corn oil as vehicle (MHLW 2000). Food consumption and body weight were determined. The animal’s state of health was checked by cage side observations as well as by detailed clinical observations. Clinicochemical and hematological examinations as well as urinalysis were carried out at the end of the administration period and after a recovery period of 14 days. No deaths occurred in either sex. No effects of polychloro copper phthalocyanine 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.

 

In two 90 day subchronic studies with F344 rats and B6C3F1 mice, male and female animals received dose levels of 5.0, 2.5, 1.25, 0.6 and 0.3 % (w/w) copper phthalocyanine, administered in the food (approx. 300, 600, 1200, 2300 and 4600 mg/kg bw for male rats, approx. 300, 600, 1250, 2500 and 5000 mg/kg bw for female rats as well as approx. 0, 1000, 2000, 4000, 8000 or 16000 mg/kg bw/day for male mice and approx. 0, 1200, 2500, 5000, 10000 and 20000 mg/kg bw/day for female mice, calculated on average food consumption, for 91 consecutive days (Batelle 1979).Animals were observed twice each day for clinical signs, with at least 6 hours between observations. All clinical signs were recorded daily. Gross examinations were performed on all animals from all dosage groups. Microscopic examinations were performed from kidney, liver, lung, heart, pancreas and pituitary from all animals in the control group and the highest dose treatment group. No clinical chemistry, hematology, or urinalysis were conducted and no organ weights were taken.

No substance related mortality was reported in rats, in mice 4 deaths occurred during the study which were not considered to be test substance related. No treatment related abnormal clinical signs were observed in either rats or mice. In mice, there were no trends in diet consumption among dosed animals compared with controls in either male or female mice. In rats there were slight trends in patterns of diet consumption between dosed and control rats of both sexes, with dosage groups eating about 1 g more of the higher concentrations of the dosed feed. In rats there were dose-related trends in body weights among both male and female rats, when body weights are expressed in percent differentials of weight gains compared with untreated controls. Male rats at the highest doses of 5.0 % and 2.5 % had differential weight gains of -11 % and -5 % respectively. Female rats at the top doses of 5.0 and 2.5 % had differential weight gains of -9.0 %. In mice, a -9 % to +8 % differential weight gain was seen in the dosed females. Animals in the highest dose levels had less weight gain than controls. Dosed male mouse groups showed a positive weight differential in all groups except the 0.6 % dosage group. In this group during week 12 with a corresponding weight loss was observed, which was not fully recovered during the final week of the study. However, given the normal variability in rodent body weight measurements, this differences did not necessarily reflect manifestation of toxicity.

No substance related changes were reported on macroscopic and microscopic examination of the animals.

 

CAS No. 14832-53-6 (fully chlorinated copper phthalocyanine, covered by definition of Pigment Green 7)

A GLP-compliant 28 day subacute study was conducted, also according to the Japanese guideline for 28 Day Repeated Dose Toxicity Test of Chemicals with Wistar rats, which received 0, 20, 140 and 1000 mg/kg/day copper perchloro phthalocyanine by gavage using olive oil as vehicle (JETOC 1997). The animals were observed for clinical signs, body weights and food consumption; hematological and blood chemical examinations, urinalysis, and padiological examination were conducted. No deaths occurred in either sex. No effects of copper perchloropolychloro phthalocyanine 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.

Justification for classification or non-classification

 

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. There were no significant toxic effects at doses of less than 300 mg/kg bw upon subacute oral exposure in rats. As a result the substance is not classified for repeated dose toxicity under Regulation (EC) No. 1272/2008, as amended for the fifteenth time in Regulation (EC) No. 2020/1182.