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EC number: 939-137-4 | CAS number: -
No studies are available for hydroxyethylpiperazine mixture. Studies concerning repeated dose toxicity are available from piperazine dihydrochloride (CAS 142-64-3). This corresponds to 52.25% piperazine base which is one constiutent of the hydroxyethylpiperazine mixture (piperazine CAS 110-85-0).Oral:rat: NOAEL = 627 mg/kg bw/day ( 90-day feeding, GLP guideline study, Dow, 1999)dog: NOAEL = 25 mg/kg bw/day ( 90-day feeding, similar to guideline, Huntsman, 1975)human: LOAEL = 30 mg/kg bw/day (case report from use of piperazine as antihelmintic agent, 3-7 days)
In a 90-day study rats were dosed with Piperazine-dihydrochloride administred in the diet. The doses were 400, 1200 and 2394 mg/kg bw/day, administered to 20 animals/sex/dose. The only effects noted was a dose related decrease in body-weight gain. NOAEL for repeated dose toxicity to the rat was 627 mg/kg bw/day, recalculated to piperazine base.
No studies are available for hydroxyethylpiperazine mixture. Studies concerning repeated dose toxicity are available from piperazine dihydrochloride (CAS 142-64-3). This corresponds to 52.25% piperazine base which is one constiutent of the hydroxyethylpiperazine mixture (piperazine CAS 110-85-0). Therefore these studies may be used as read across in order to assess the repeated dose toxicity of hydroxehtylpiperazine mixture.
In a 90-day feeding study 20 male and 20 female Sprague-Dawley rats (GLP guideline study, Dow, 1999) were dosed daily with 400, 1200 and 2394 mg/kg bw piperazine dihydrochloride. The only effect noted was a dose related decrease in body weight gain (10% decrease compared to control). NOAEL for repeated dose toxicity to the rat was therefore set to 627 mg/kg/day, recalculated to piperazine base.
In a further 90-day feeding study with 16 beagle dogs/sex/dose the toxicity of piperazine dihydrochloride was investigated (similar to OECD 409, Huntsman, 1975). The doses 92.3, 369.2 and 3692 ppm daily did not result in any signs of systemic toxicity in any of the test animals. All dogs showed slight to moderate weight gains and food consumption was generally comparable between test and control groups. No gross or microscopic pathology attributable to the test substance were observed at termination. NOAEL for repeated dose toxicity to the dog was 25 mg/kgbw/day, recalculated to piperazine base.
In conclusion, both studies showed no adverse effect but in a developmental toxicity study with rabbits, neurotoxic effects were noted. The NOAEL in this study was 42 mg/kg bw/day. Furthermore, in the use of piperazine as antihelmintic agent, neurotoxic effects have been noted in humans (EU Risk Assessment, 2005). A LOAEL of 30 mg/kg bw/day can be established for a limited exposure of 3 to 7 days.
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 repeated dose toxicity under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008
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