[2-(29H,31H-phthalocyaninylmethyl)-1H-isoindole-1,3(2H)-dionato(2-)-N29,N30,N31,N32]copper

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

1 000 mg/kg bw/day

Species:

rat

Effect on fertility: via inhalation route

Endpoint conclusion:

no study available

Effect on fertility: via dermal route

Endpoint conclusion:

no study available

Additional information

A screening study for reproductive toxicity (OECD 421, JETOC 1995) performed with the copperphthalocyanine core was used to fill the data gap for reproductive toxicity. It shows absence of effects at the limit dose of 1000 mg/kg bw. The actual argument is however that the substance is not taken up by the body after oral dosing. In support of this, a fourteen day gavage study with doses of 300 and 1000 mg/kg bw was performed with each five male and female rats (BASF 2015). There was no indication of systemic uptake as judged from unchanged plasma and liver copper levels (see also toxicokinetic section). There were no treatment-related clinical signs, no adverse effects on haematology, clinical chemistry, body weights or organ weights. The NOEL for 14-day oral gavage dosing was 1000 mg/kg bw. This study was to performed to support read-across to the core structure copper phthalocyanine (CAS 147-14-8) and to show absence of systemic uptake. Copperphthalocyanine is an inert pigment of extremely low solubility in water (0.0004mg/L) and octanol (0.009mg/L) that is not taken up by experimental animals after oral dosing. Phthalocyanine IM contains additional 1H-isoindole-1,3(2H)-dion subsitutents attached to the ring via a methylene bridge. The substituents add to the conjugated system and contain no charges that do not affect water solubility, they are no ionisable at environmental pH. They increase the diameter and molecular weight which reduces the already non-existent ability for systemic uptake.

Therefore, the reproductive toxicity screening studies with the core structure are suitable for the hazard assessment of CAS 42739 -64 -0

For a detailed read-across justification including a datamatrix, it is referred to the attachment (IUCLID toxicokinetic section).

Short description of key information:
Based on an OECD Guideline 421 and GLP study with CAS number 147-14-8, the NOAEL for reproductive toxicity was considered to be 1000 mg/kg bw/day for all relevant endpoints, which was the highest dose tested.

Effects on developmental toxicity

Description of key information

In an OECD Guideline 421 and GLP study with CAS-nr. 147-14-8 in rats, the NOAEL for development of offspring was at the highest test dose of 1000 mg/kg/day. 

Effect on developmental toxicity: via oral route

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

1 000 mg/kg bw/day

Species:

rat

Effect on developmental toxicity: via inhalation route

Endpoint conclusion:

no study available

Effect on developmental toxicity: via dermal route

Endpoint conclusion:

no study available

Additional information

Please refer to the discussion of "Effects on fertility" (see above).

Justification for selection of Effect on developmental toxicity: via oral route:
Most reliable study

Justification for classification or non-classification

Based on the results obtained from reproduction/developmental testing, the test substance is not considered to be subject to classification and labelling for toxicity to reproduction/development according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP).