Hydrogen [29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cuprate(1-), compound with dodecylamine (1:1)

Endpoint summary

Description of key information

The substance is taken up after ingestion as shown by systemic effects observed at 1000 mg/kg bw in the subacute gavage study in rats. Uptake via the dermal route is unlikely because the substance is of low solubility in octanol and water and because the components are of a molecular weight between 656 and 870 g/mol. After inhalation, clearance is expected to occur mainly via macrophages and via mucosal transport into the stomach. Since the substance is surface active, systemic uptake through the lung cannot be excluded although size and solubility are not favourable for passage of biological membranes.

Key value for chemical safety assessment

Bioaccumulation potential:

no bioaccumulation potential

Additional information

Rudimentary toxicokinetic information can be obtained from following the blue color of the test substance chromophore and the results of the toxicity studies and physico-chemical data.

The UVCB substance is mainly a 1:1 salt of a mono-sulfonated copper phthalocyanine with1-dodecanamine. The non-coloured amine has a molecular weight of 172 g/mol whereas the blue sulfonated copper phthalocyanine has a molecular weight of 656 g/mol. As the position of the sulfonic acid on the phthalocyanine ring varies the substance is a mixture of isomers (UVCB). In addition, there is a fraction of free blue copper phthalocyanine sulfonic acid.

Water and octanol solubility based on both copper and carbon content are in the range of 15 – 200 mg/L and depend on the loading rate. The surface tension of 54 mN/m of a saturated solution indicates surface activity. From the solubilities, the n-octanol/water partition coefficient is calculated to be less than 0.1. The substance is considering to be irritating to eyes based on in-vitro studies.

After ingestion, most of the substance is not absorbed: Blue discoloration of the faeces occurred at 100, 300 and 1000 mg/kg bw/day in all animals. At necropsy, bluish contents of the gastro-intestinal tract was noted in most animals given the test substance. Notably, no bluish internal tissue discoloration and no green discoloration of urine was reported.

Uptake appears to occur via the mesenteric lymph nodes as increased macrophage foci in the mesenteric lymph node were present in 4/5 males (3 slight, 1 moderate) treated at 1000 mg/kg bw/day and at increased incidence and/or severity in 4/5 females (3 slight, 1 moderate) treated at 1000 mg/kg bw/day, compared to 4/5 control (3 minimal, 1 slight), 2/5 100 mg/kg bw/day (2 minimal) and 2/5 300 mg/kg bw/day (2 minimal) treated females.

Distribution to the liver is indicated by histopathology findings: The microgranulomas observed at 1000 mg/kg bw represent a multifocal inflammatory response to a difficult to digest and eliminate insult by the test substance and this is not normally seen in the liver. The increased macrophage foci in the mesenteric lymph node also likely represent the response to a difficult to digest and eliminate insult by the test substance.

In addition, hyperplasia/hypertrophy of the urothelium in the urinary bladder might indicate renal elimination of non-coloured metabolites, possibly of the alkylamine. Of interest, the registrant owns a repeated dose toxicity study with a disodium salt of disulfonated copper phthalocyanine (CAS 1330-38-7) which showed no adverse effects at the highest dose level of 1000 mg/kg bw. In that study, green coloration of urine was observed.

Absence of a bioaccumulation potential is concluded from the lack of bluish discoloration of internal organs. It shows that the chromophore is eliminated or degraded. It is consistent with the log P_OW of less than 0.1.