Reaction product of Chloro[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]aluminium, sulphuric acid and caustic soda

Specific investigations: other studies

Description of key information

Based on a number of studies, it is concluded that the substance is not skin phototoxic when applied dermally up to a concentration of 3% and also not photoallergenic up to a concentration of 0.1%.

Additional information

Skin phototoxicity

A number of skin phototoxicity studies has been performed in mice and rats. The combined results indicate that, though severe effects (mortality) were seen after intraperitoneal administration, administration of concentrations up to 3% on the intact skin of animals does not lead to treatment related effects of phototoxicity. A photoallergenicity study in Guinea pigs did not provide indications that the substance has photoallergenic properties at the doses tested.

In a study on mice (3 males and 3 females per group), concentrations ranging from 0 to 3% of the substance were applied to one side of the mouse, where the other side functioned as an internal control (CIBA-GEIGY, 1979). There were no positive reactions seen in any of the treated animals. In another study on mice (4 animals per group), concentrations between 0 and 3% were applied to the dorsum of mice (Unilever, 1980). Control groups received test agent, but no light or solvent with and without light. In this study, the reaction of the test groups were similar to those of the control groups. In the same study, also rats were treated topically with 0.3% of substance (4 animals per group). Higher concentrations were not used, because in a preliminary irritation study, excess substance could not be succesfully removed from the skin. At the tested concentration, a statistically significant positive reaction was seen at the observation 24 hours after treatment, but no effect was seen at other moments (3 and 6 hours, 48 hours and 72 hours). In the same study, also intraperitoneal administration at 6 doses (0 to 290 mg/kg bw) was used with irratiation to test for potential phototoxicity. This study was done with mice (2 per group). At a dose of 5.1 mg/kg bw with irradiation skin lesions were observed, while higher doses with irradiation were found to be lethal. In the absence of light the test substance was not toxic in any of the concentrations.

Skin photoallergenicity

In a study in Guinea pigs (10 males and 10 females per group), photoallergenicity was studied (CIBA-GEIGY, 1979). Induction was via repeated epidermal open exposure, followed by irradiation, 4 times per week for three weeks. A challenge via epidermal open exposure was made 12 days after the last irradiation, followed by irradiation and a second challenge after a 14 days rest period. Not a single erythema reaction was observed, neither in the control group, nor in the test group.