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Administrative data

Description of key information

Acute toxicity data indicate a low toxicity: in rats the oral and dermal LD50 was > 2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Oral toxicity

In a GLP compliant study, according to OECD guideline 423 and EU method B.1 tris, the acute oral toxicity of ZPS following a single oral administration in Wistar rats was investigated (RCC Ltd, 2001). A group of fasted animals (3/sex) was treated by gavage with ZPS in bi-distilled water at a dose level of 2000 mg/kg bw and observed for 15 days. All animals survived until the end of the study period. No clinical signs were evident during the course of the study. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy. The median lethal dose (LD50) of ZPS after single oral administration to rats of both sexes is > 2000 mg/kg bw.

 

In an oral toxicity study, comparable to OECD guideline 401, Sprague-Dawley rats were administered ZPS at 3860, 5560, 6400, 7200, 7600 (10 females/dose) and 8000 (20 males and 10 females) mg/kg bw by single dose (gavage) followed by a 14-day observation period (Rattech Science Services Laboratories, 1981). The LD50 was > 8000 mg/kg bw for males and 7100 mg/kg bw for females.

 

In an oral toxicity study, comparable to OECD guideline 425, Sprague-Dawley rats were administered ZPS at 9200, 12000, 15600, 20300 and 26400 (up and down test, 1 animal/dose) and 26400 (limit test, 5 males and 5 females) mg/kg bw by single dose (gavage) followed by a 14-day observation period (The Procter & Gamble Company, 1986). The LD50 was > 26400 mg/kg bw.

Dermal toxicity

In a GLP compliant study, according to OECD guideline 402 and EU method B.3, the acute dermal toxicity of ZPS following a single dose in Wistar rats was investigated (Bioassay, 2012). A group of animals (5/sex) was dermally exposed for 24 hours to ZPS in olive oil Ph. Eur. at a dose level of 2000 mg/kg bw and observed for 14 days. All animals survived until the end of the study period. No signs of toxicity, erythema or edema were noted. A turquoise discoloured application area was observed up to 6 days after exposure. The body weight of the animals increased within the normal range. No macroscopic findings were observed at necropsy. The median lethal dose (LD50) of ZPS after single dermal exposure to rats of both sexes is > 2000 mg/kg bw.

Justification for classification or non-classification

Based on the results of the acute oral and dermal toxicity studies, ZPS does not need to be classified according to Directive 67/548/EEC and according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.