[2,9,16,23-tetrachloro-29H,31H-phthalocyaninato(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:

A category assessment is performed, which is based on the hypothesis that the copper phthalocyanine pigments are too insoluble in water or fat / octanol to cause local effects. Experimental data is available both for the core structure which has the lowest molecular weight and for a chlorinated derivative. A data matrix and further information are provided in the chapter on toxicokinetic properties. The pigment is considered to be not skin sensitizing.

CAS No. 147-14-8:

Skin sensitization

There is information available to assess the skin sensitization potential of copper phthalocyanine.

An in vivo study with 10 female guinea pigs in the test group and 5 female guinea pigs as control group was conducted, according to the method described by Magnusson and Kligman. The intradermal induction (6 injections in groups of two per animal) was conducted with FCA, the test material 7.5 % (w/v) in Alembicol D and the test material 7.5 % (w/v) in a mixture of FCA and Alembicol D. Epicutaneous induction (one week after intradermal induction) was conducted with 50 % of the test material in Alembicol D. The challenge (14 days after epicutaneous induction) was performed with 25 % and with 50 % of the test material in Alembicol D (acc. OECD 406, GLP; Huntingdon 2001). No animal in the control group and no animal in the treated group exhibited positive reactions 24 or 48 hours after the challenge procedure.

In another study, a local lymph node assay was conducted according to OECD 429 and under GLP conditions (Safepharm 2004). Four female CBA/CaBkl mice per dose (5 %, 10 % or 25 % w/w of the test material in acetone/olive oil 4:1 v/v) were treated by daily application of 25 µl of the appropriate concentration of either the test material or with vehicle alone to the dorsal surface of each ear for 3 consecutive days. Five days following the first topical application, all mice were injected via the tail vein with 250 µl of phosphate buffered saline (PBS) containing 20 µCi 3H-methyl thymidine (3HTdR) to each mouse. Animals were observed post dose, any signs of toxicity or ill health were recorded. The body weight of the animals was determined prior to dosing and prior to termination. 5 hours following administration of 3HTdR all animals were killed. The draining auricular lymph nodes were excised, pooled for each group and a single cell suspension of the cells was prepared. 3HTdR incorporation was measured by ß-scintillation counting. The proliferation response of the lymph node cells was expressed as the number of radioactive disintegrations per minute per lymph node (dpm/node) and as the ratio of 3HTdR incorporation into the lymph node cells of test nodes relative to that recorded for the control nodes (stimulation index). There were no early deaths during the study. No signs of systemic toxicity was noted in the test or in the control animals during the study. Blue-coloured staining on the ears, face, feet and fur was noted in all test animals during the study. The body weight changes of the test animals during the study were comparable to those observed in the corresponding control animals over the same time period. A stimulation index of less than 3 was recorded for the three concentrations of the test material, indicating no sensitizing potential of the tested material.

In an in vivo study with guinea pigs with limited validity, copper phthalocyanine apparently gave no evidence of skin sensitization in animal studies according to the authors (Kochanov 1966, Val. 4). However, relevant data were not reported (i.e. induction/ challenge routes and concentrations).

 

CAS No. 1328-53-6:

Skin sensitization

There is only limited information available concerning the skin sensitization potential of polychloro copper phthalocyanine.

In an in vivo study with guinea pigs polychloro copper phthalocyanine apparently gave no evidence of skin sensitization in animal studies according to the authors (Putilina 1976, Val. 4). However, relevant data were not reported (i.e. induction/ challenge routes and concentrations).

CAS No. 27614 -71 -7:

Skin sensitization

A local lymph node assay was conducted according to OECD 429 and under GLP conditions (RCC 2004). Groups of four female CBA mice per dose (5 %, 10 % or 25 % w/w of the test material in DMSO) were treated by daily application of 25 µl of the appropriate concentration of either the test material or with vehicle alone to the dorsal surface of each ear for 3 consecutive days. Five days following the first topical application, all mice were injected via the tail vein with 250 µl of phosphate buffered saline (PBS) containing 19.9 µCi 3H-methyl thymidine (3HTdR) to each mouse. Animals were observed post dose, any signs of toxicity or ill health were recorded. The body weight of the animals was determined prior to dosing and prior to termination. 5 hours following administration of 3HTdR all animals were killed. The draining auricular lymph nodes were excised, pooled for each group and a single cell suspension of the cells was prepared. 3HTdR incorporation was measured by ß-scintillation counting. The proliferation response of the lymph node cells was expressed as the number of radioactive disintegrations per minute per lymph node (dpm/node) and as the ratio of 3HTdR incorporation into the lymph node cells of test nodes relative to that recorded for the control nodes (stimulation index). There were no early deaths during the study. No signs of systemic toxicity was noted in the test or in the control animals during the study. The body weight changes of the test animals during the study were comparable to those observed in the corresponding control animals over the same time period (except for one animal of the 10 % test item concentration group which lost weight during the study, but this was considered to be incidental). No dose-response relation was observed and a stimulation index of less than 3 was recorded for the three concentrations of the test material. The test item concentration of 2.5 % produced a S.I. of 0.8, a concentration of 5.0 % produced a S.I. of 1.1 and a concentration of 10.0 % produced a S.I. of 1.0.

 

Migrated from Short description of key information:
The pigment is considered to not skin sensitizing.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

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. 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.