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

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

No experimental data is available for the substance itself, but the UVCB analogue with the slightly average substitution grade (2.48 versus 1.4) has been tested. Both substances share the same components; the analogue UVCB substance contains more of the higher substituted components. All components are poorly soluble and have a molecular weight greater than 500 g/mol and have a poor potential for skin permeability. The adverse outcome pathway for skin sensitization begins is based on the molecular initiating event of protein binding. In this case, the structural features are identical and any potential for protein reactivity present in the target substance would be identified from the higher substituted analogue.  In addition, neither the phtthalocyanine core nor the phthalimide substitutent on their own are skin sensitizers (see data matrix). Therefore, it is acceptable to use the data of the analogue for read-across.

The analogue with the higher average substitution grade was assessed for its skin sensitising potential using the Local Lymph Node Assay (LLNA) in mice. That study fulfilled all validity criteria in that it followed the OECD guideline 429 and was performed under GLP. Test item suspension at different concentrations was prepared in the vehicle propylene glycol. The local lymph node assay was performed using test item concentrations of 2, 5, and 10% (w/w). The highest concentration tested was the highest concentration that could be achieved whilst avoiding systemic toxicity and excessive local skin irritation (as determined by a pre-experiment). The animals did not show any signs of systemic toxicity or local skin irritation during the course of the study and no cases of mortality were observed. A possible erythema of the ear skin could not be evaluated due to the inherent colour of the test item. Stimulation Indices (S.I.) of 0.69, 0.95 and 1.24 were determined with the test item at concentrations of 2, 5, and 10% (w/w) in propylene glycol, respectively. A statistically significant and biologically relevant increase in DPM value and also in lymph node

weight and cell count was not observed in any dose group in comparison to the vehicle control group. Furthermore, the cut-off value of 1.55 for a positive response regarding the lymph node cell count index reported for BALB/c mice was not reached in any dose group.

A general read-across justification with data matraces and structures has been added to the Chemical safety report (toxicokinetic section.)

Migrated from Short description of key information:
A related substance did not induce skin sensitization in the LLNA (BASF 2014).

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available study is considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for skin sensitization 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 skin sensitization under Regulation (EC) No. 1272/2008, as amended for the fifth time in Directive EC944/2013.