[2,9,16,23-tetrachloro-29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]copper

Endpoint summary

Description of key information

Copper phthalocyanine pigments are non-hazardous after single ingestion or short-term skin contact. They are considered to behave like inert dust in regard to dust inhalation.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Additional information

A category assessment is performed, which is based on the hypothesis that the copper phthalocyanine pigments are too insoluble in water or fat / octanol for systemic uptake. A data matrix and further information are provided in the chapter on toxicokinetic properties. The pigment is considered to show no adverse effects at the limit dose for the oral and dermal route. It is considered to behave like an inert dust upon inhalation.

Data on category members is summarized below:

CAS No. 147-14-8:

Oral

There are valid data available for the assessment of the acute oral toxicity of Copper phthalocyanine. Five male and five female Sprague-Dawley rats were treated with 200, 1600, 3200, 6400 mg/kg bw under standardized conditions; the test method is comparable to OECD guideline 401. The animals were observed for 14 d, necropsy was performed even with the survivors. The LD50 was > 6400 mg/kg bw for male and female rats. No mortality was observed at any dose group and autopsy revealed no relevant findings. Clinical signs were reported for all groups. In the 6400 - 3200 mg/kg bw groups, ca. 4 hours after application the animals were found in a crouched down position with intermittent breath. On the following morning slight apathy, a crouched down position and intermittent breath were observed. The stool of the animals was bluish discoloured until day 4. On the following days the animals were without any findings. In the 1600 - 200 mg/kg bw groups, immediately after application, irregular breath and masticatory movement were observed, after 4 hours the animals were found in a crouched down position. On the following days until day 3, the stool of the animals was bluish discoloured but later on the animals were without any findings (BASF AG, 1971).

In another supporting study, conducted with five male and five female mice per group, the animals were treated with 0 or 16000 mg/kg bw under standardized conditions and were observed for 14 d, necropsy was performed with all animals. The LD50 was > 16000 mg/kg bw for male and female mice. No mortality was observed and autopsy revealed no relevant findings. The following clinical signs were reported shortly after dosing in all treated mice: pilo-erection and abnormal body carriage (hunched posture) and abnormal gait (waddling). These findings were accompanied by lethargy (4 animals), ptosis (1 animal), diarrhoea, coloured blue (1 animal). Recovery of all treated mice as judged by external appearance and behaviour, was apparently complete within 4 days of dosing (Huntingdon 1981, Val. 2).

Other studies with partially limited reliability provided a LD50 range of > 10000 to > 15000 mg/kg bw in rats (Kurlandsky 1984, Val. 4; Webb 1984 Val. 4), the LD 50 value for another common test species (mouse) was > 10000 mg/kg bw (Gosselin 1976, Val. 4).

Dermal

There are valid data available for the assessment of the acute dermal toxicity of Copper phthalocyanine. Five male Wistar rats were treated with 5000 mg/kg bw under standardized conditions; the test method was acc. to OECD guideline 401 (limit test). The animals were observed for 14 d, necropsy was performed even with the survivors. The LD50 was > 5000 mg/kg bw for male rats. No mortality was observed, autopsy revealed no relevant findings and no clinical signs of toxicity were reported. Body weight gain was within the normal range (Synthesia 2009, Val. 2).

CAS No. 1328-53-6:

Oral

There are valid data available for the assessment of the acute oral toxicity of polychloro copper phthalocyanine. Five male and five female Sprague-Dawley rats were treated with doses of 200, 1600, 3200 and 6400 mg/kg bw of polychloro copper phthalocyanine under standardized conditions; the test method is comparable to OECD guideline 401 (BASF AG, 1971). The animals were observed for 14 d, necropsy was performed even with the survivors. The LD50 was > 6400 mg/kg bw for male and female rats. All animals survived, no mortality was observed, and no abnormalities were found in the organs. Green feces were observed in all animals treated 24 hours after application of the test material. Dyspnea was observed in animals of the 1600 mg/kg bw group immediately after treatment, but was reversible.

In a supporting limit test,comparable to OECD guideline 401, five Sprague-Dawley rats per sex were administered to a single dose of 5000 mg/kg bw polychloro copper phthalocyanine (BASF AG 1980). The animals were observed for 14 d, necropsy was performed even with the survivors. Here, the LD50 was > 5000 mg/kg bw. All animals survived, no mortality was observed, and no abnormalities were found in the organs. Dyspnea, apathy, green feces as well as a poor general state were observed. A slight decrease of the average body weight in the female group was seen on day 13.

Other studies in rat with partially limited reliability provided a LD50 range of > 2000 to > 10000 mg/kg bw polychloro copper phthalocyanine in rats, in all three cases no mortalities occured (JETOC 2001, Val. 2; JETOC 1997, Val. 2; Putilina 1976, Val. 4).

The LD 50 value for another common test species (mouse) was > 10000 mg/kg bw polychloro copper phthalocyanine (Gosselin 1976, Val. 4).

Inhalation

No valid data are available for the assessment of the acute inhalation toxicity of polychloro copper phthalocyanine. A standardized inhalation hazard test was conducted to assessthe acute inhalation toxicityof polychloro copper phthalocyanine. However, the system used was unsuitable in this case (Val. 4), as the IHT is insufficient for non-volatile substances, such as the solid substance polychloro copper phthalocyanine. 0/6 rats died after 7 h exposure at room temperature. No clinical signs of toxicity were seen and autopsy revealed no abnormal findings. A considerable formation of dust was reported (BASF AG 1980).

 

CAS No. 574-93-6:

Oral

There are valid data available for the assessment of the acute oral toxicity of Heliogen Blue MFA. In a limit test (comparable to OECD guideline 401), five Sprague-Dawley rats per sex were administered 5000 mg/kg bw Heliogen Blue (BASF AG 1980). The animals were observed for 14 d, necropsy was performed even with the survivors. The LD50 was > 5000 mg/kg bw. All animals survived, no mortality was observed. No clinical signs of toxicity were seen. Autopsy revealed no abnormal findings.

In a supporting study using a test method also comparable to OECD guideline 401, five Sprague-Dawley rats per sex were administered 5000, 6400, 8000 and 10000 mg/kg bw Heliogen Blue MFA, respectively (BASF AG 1980). The animals were observed for 14 d, necropsy was performed even with the survivors. The LD50 was > 5000 mg/kg bw. All animals survived, no mortality was observed. No clinical signs of toxicity were seen. Autopsy revealed no abnormal findings.

Inhalation

No valid data are available for the assessment of the acute inhalation toxicity of Heliogen Blue MFA. A standardized inhalation hazard test was conducted to assessthe acute inhalation toxicityof Heliogen Blue. However, the system used was unsuitable in this case (Val. 4), as the IHT is insufficient for non-volatile substances, such as the solid substance Heliogen Blue. 0/6 rats died after 7 h exposure at room temperature. No clinical signs of toxicity were seen and autopsy revealed no abnormal findings (BASF AG 1980).

CAS No. 14302 -13 -7:

Oral

There are valid data available for the assessment of the acute oral toxicity of Lionol Green 6YK. In a limit test five HC/CFLP mice of both sexes were administered to single doses of 0 or 5000 mg/kg bw Lionol Green 6YK (Huntingdon 1984, Val.2). The animals were observed for 14 d, necropsy was performed with all animals. The LD50 was > 16000 mg/kg bw. All animals survived, no mortality was observed, and no abnormalities were found in the organs. Pilo-erection was observed following dosing in all treated mice with recovery apparently completed by day 2.

CAS No. 27614-71-7:

Oral

There are valid data available for the assessment of the acute oral toxicity of Hostaperm Blau BT-729-D. In a limit test five Sprrague-Dawley rats of both sexes were administered to a single dose of 2000 mg/kg bw (acc. OECD 401, Aventis Pharma 2000). The animals were observed for 14 d, necropsy was performed with all animals. The LD50 was > 2000 mg/kg bw. All animals survived, no mortality was observed, and no abnormalities were found in the organs. Development of body weight was not impaired, except one female, which suffered a loss of body weight between day 8 and day 15. Bluish discoloured feces were observed after the administration of the test material. From day 4 until the end of the study no findings were observed.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for acute oral or dermal toxicity under Directive 67/548/EEC, as amended for the 31st time in Directive2009/2/EG.

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. As a result the substance is not considered to be classified for acute oral or dermal toxicity under Regulation (EC) No. 1272/2008, as amended for the fifth time in Directive EC 944/2013.