[1,3,8,16,18,24-hexabromo-2,4,9,10,11,15,17,22,23,25-decachloro-29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]copper

Endpoint summary

Description of key information

The substance is assessed as a non-sensitizer in the LLNA by read-across.

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

The following summarizes the studies performed with the source chemicals. The read-across justification is attached to the endpoint study record.

CAS No. 147-14-8 (two OECD 406, one OECD 429):

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.

Skin sensitizazion testing was performed in female guinea pigs according to the method of MAGNUSSON & KLIGMAN (OECD 406) and under GLP.Intradermal induction was performed using 5 % Pigment Blue 15 in sesam oil (Aventis 2002). Dermal induction and challenge treatment were carried out with 25 % Pigment Blue 15 in sesam oil.The validity of the test system is confirmed by the periodically conducted positive control test using alpha-hexylcinnamaldehyde for the maximization test.Based on the results of this study Pigment Blue 15 showed no evidence for sensitizing properties according to the classification criteria of Directive  2001/59/EC.

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.

 

CAS No. 1328-53-6:

Skin sensitization

A local lymph node assay was conducted according to OECD 429 and under GLP conditions (RCC 2004).

Three groups each of four female mice were treated daily with the test item at concentrations of 5 %, 10 % and 25 % (w/v) in dimethylsulfoxide (DMSO) by topical application to the dorsum of each ear lobe (left and right) for three consecutive days. 25 % was the highest technically achievable concentrationinthe vehicle. A control group of four mice was treated with the vehicle (dimethylsulfoxide (DMSO)) only. Five days after the first topicalapplicationthe mice were injected intravenouslyintoa tail vein with radio-labelled thymidine (3H-methyl thymidine). Approximately five hours after intravenous injection, the mice were sacrificed, the draining auricular lymph nodes excised and pooled per group. Single cell suspensions of lymph node cells were prepared from pooled lymph nodes which were subsequently washed and incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymp node cells was determined by the incorporation of 3H-methyl thymidine measured in aß-scintillation counter.

No clinical signs were observed.All treated animals survived the scheduled study period.

The results obtained (STIMULATION INDEX (S.I.)) were 1.4, 1.3 and 1.3 for all three test groups.

 

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.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data for the structural analogues are reliable and suitable for classification purposes under Regulation 1272/2008. The stimulation indices in the LLNA (OECD 429) did not show a dose dependent increase. No EC3 could be established. The GPMTs also did not show adverse skin reactions. As a result the substance is not considered to be classified for skin sensitization under Regulation (EC) No. 1272/2008,as amended for the seventh time in Regulation (EC) No 2015/1221.