Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

There is no indication from animal studies or human information that this substances may cause cancer. Therefore, there is no need to classify for carcinogenicity.

Additional information

According to the REACH regulation, additional data on carcinogenicity need to be conducted if no clear conclusions about germ cell mutagenicity can be made. In this case additional investigations shall be considered.

Copper phthalocyanines are inactive for genotoxicity in-vitro as well as in-vivo.

Additionally, there is no evidence from the repeated dose studies that the substance is able to induce hyperplasia and/or pre-neoplastic lesions.

In a short report on a study with limited validity, no tumors were seen in 17 mice given 34 weeks subcutaneous injections of ca. 25 mg/kg bw/day of Pigment Blue 15 (CAS 147 -14 -8) after a period of 8 months (Haddow 1960).

The National Toxicology Program (NTP) decided not to conduct a long term bioassay with phthalocyanine blue and green pigments based upon the results of their own 90-day feeding studies conducted on mice and rats. During these studies, mice and rats were fed phthalocyanine pigments in their diets at concentrations between 0.3 and 5 %. No signs of toxicity were observed. Based on results of their 90-day studies, NTP concluded that the test substance is not likely to bebioavailable (long term studies revealed no adverse effects nor evidence of absorption of the test substance), and NTP accordingly dropped it plans to conduct long-term bioassays on the phthalocyanine blue and green pigments.

As a consequence, there is no need for further testing phthalocyanins in terms of carcinogenicity.