RESUMEN
OBJECTIVE: To investigate the safety of hair essence containing 0.05% purified bee venom (HE-PBV) on the skin and eyes of New Zealand White rabbits. METHODS: HE-PBV which contained 0.05% PBV, purified water, and glycerin, was used as the test substance. The skin-irritation test (SIT) and eye-irritation test (EIT) were conducted according to the Draize method. On the SIT, HE-PBV (0.5 mL) dropped gauze was attached both intact and abraded skin for 24 h. The other side of the skin was used as control. After 24 and 72 h, the treatment site was observed and scored according to evaluation criteria for skin reactions. On the EIT, the rabbits were divided into two groups: eye-washed (three rabbits) and non-eye-washed (six rabbits). HE-PBV (0.1 mL) was squirted into the right eye of rabbits. The left eye was untreated and used as a control. Then, 20-30-s later, the eyes of rabbits in the eye-washed group were washed with ~50 mL of physiologic (0.9%) salt solution. Then, 1, 2, 3, 4 and 7 d after the start of the EIT, the eyes and behavior of the rabbits were observed. The degree of eye irritation elicited by HE-PBV was determined in three steps and then the criteria of the classification of eye-irritation scores. RESULTS: The SIT revealed erythema and edema at the site of HE-PBV application. At 72 h, the body weight of rabbits was reduced slightly, but other symptoms (except erythema and edema) were not observed. The Primary Irritation Index score was 0.6, and HE-PBV was deemed to be a slight irritant. The EIT did not show mortality or body-weight fluctuation, but hyperemic conjunctiva and eyelid closure were noted after HE-PBV administration. Except for these results, the score for the ophthalmic response on days 1, 2, 3, 4 and 7 was 0, and HE-PBV was deemed to be a non-irritant. CONCLUSION: These data suggest that HE-PBV did not elicit eye irritation, but was a slight irritant to the skin of rabbits; the latter slight would have been due to the excipients used in manufacture of the hair essence because PBV has been shown to be safe.