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

Endpoint summary

Description of key information

The substance is judged to be practically non-toxic in rats after single ingestion and dermal application from experimental data of an analogue UVCB substance.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

10 000 mg/kg bw

Quality of whole database:

Klimisch 2

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating conc.

Value:

5 mg/m³ air

Quality of whole database:

Klimisch 4

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 500 mg/kg bw

Quality of whole database:

Klimisch 2

Additional information

The substance itself was not tested for acute toxicity. Experimental data is available for the analogue UVCB substance CAS 559160 -79 -1 which only differs from the target substance by an higher average degree of substitution and consists of the same components. For more information supporting the read-across it is referred to the attachment in the toxicokinetic section. It includes data matrices and chemical structures.

The experimental data were generated prior to the introduction of GLP and OECD testing guidelines. Study reports containing adequate description of the experimental procedure and results and with adequate identification of the test substance are available.

The protocol for acute oral toxicity differs from the OECD testing guideline by the shorter observation period (7 instead of 14 days) and by a five-fold higher dose (10000 instead of 2000 mg/kg bw) (BASF 1976). Considering the lack of toxicity observed under these testing conditions, the study is considered to provide sufficient information despite the shorter oberservation period. Blue discoloration of the feces indicated passage of the blue colorant through the gastrointestinal tract.

The protocoal for acute dermal toxicity differs from OECD testing guideline 402 by a higher dose of 2500 mg/kg bw. No systemic toxicity was observed during the 14 -day observation period. As the test item coloured the application site, local effects could not be completely during the first part of the study. Then later no local effects were noted.

An acute inhalation study with poorly characterized dusty material in rats was performed (BASF 1976). The test atmosphere was generated by blowing air through a layer of the test material and the concentration was calculated from the weight difference of the layer of the test material. During the 8h exposure, an average concentration of ca. 5mg/L was applied. No particle size characterization and no online concentrations are available, therefore the study is only indicative. No rat died as a consequence of treatment.

In addition, a study with intraperitoneal application of 2000 mg/kg bw is available (BASF 1976). No animal died during the 8 -day observation period.

In all studies, effects were clearly absent and far away from any threshold of classification and labelling. There is no uncertainty of read-across arising from the nature or the severety of the effects.

Justification for selection of acute toxicity – inhalation endpoint
Only study available, dust poorly characterized. Study is not suitable as key study.

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. The LD50 was greater than 2000 mg/kg bw. 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. The LD50 is greater than 2000 mg/kg bw. 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.