Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the eight closest read across substances, gene mutation was predicted for piperazine 2-hydroxypropane-1,2,3-tricarboxylate. The study assumed the use of Salmonella Typhimurium strains TA 1535, TA 100, TA 98, TA 1537, TA92 and TA 94 with S9 metabolic activation system. piperazine 2-hydroxypropane-1,2,3-tricarboxylate was predicted to not induce gene mutation in Salmonella Typhimurium strains TA 1535, TA 100, TA 98, TA 1537, TA92 and TA 94 in the presence of S9 metabolic activation system and hence, according to the prediction made, it is not likely to classify as a gene mutant in vitro.

Based on the predicted result it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Gene mutation in vitro:

Prediction model based estimation and data from read across have been reviewed to determine the mutagenic nature of the test compound Piperazine citrate. The summary is as mentioned below:

Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, gene mutation was predicted for Piperazine 2-hydroxypropane-1,2,3-tricarboxylate. The study assumed the use of Salmonella typhimurium strains TA 1535, TA 100, TA 98, TA 1537, TA92 and TA 94 with and without S9 metabolic activation system. Piperazine 2-hydroxypropane-1,2,3-tricarboxylate was predicted to not induce gene mutation in Salmonella typhimurium strains TA 1535, TA 100, TA 98, TA 1537, TA92 and TA 94 in the presence and absence of S9 metabolic activation system and hence, according to the prediction made, it is not likely to classify as a gene mutant in vitro.

Mouse lymphoma study was performed by Cole and Arlett (1976) to evaluate the mutagenic nature of the test compound Piperazine compound with phosphoric acid (RA CAS no 1951 -97 -9). The test compound was studied at dose levels of 200, 250, 300, 350, and 400 µ/L of Piperazine, compound with phosphoric acid, with and without metabolic activation system. The test compound failed to induce mutation in the mouse lymphoma cell line with and without metabolic activation. Thus the substance can be concluded to be non genotoxic and is not likely to classify for gene mutation in vitro.

In vitro mammalian chromosome aberration test was performed to evaluate the mutagenic nature of the test compound Piperazine compound with phosphoric acid. At concentrations ranging from 1.7 to 110 mg/ml, piperazine phosphate was found to lack clastogenic properties in cultivated Chinese hamster ovary cells in presence and absence of metabolic activation. Thus the test chemical is not likely to classify as gene mutant on vitro.

Based on the weight of evidence data summarized, the test chemical Piperazine citrate is not likely to classify a gene mutant in vitro.

Justification for classification or non-classification

Based on the weight of evidence data summarized, the test chemical Piperazine citrate is not likely to classify a gene mutant in vitro.