2-piperazin-1-ylethylamine

PBT assessment

PBT assessment: overall result

Reference

Reference 1

Name:

2-piperazin-1-ylethylamine

Type of composition:

legal entity composition of the substance

State / form:

liquid

>= 98.5 - <= 100 % (w/w)

Reference substance:

2-piperazin-1-ylethylamine

Reference substance:

2-piperazin-1-ylethylamine

This impurity is considered relevant for the classification and labelling of the substance

Reference 2

Name:

2-piperazin-1-ylethylamine

Type of composition:

boundary composition of the substance

State / form:

liquid

> 98 - < 100 % (w/w)

Reference substance:

2-piperazin-1-ylethylamine

Reference substance:

2-piperazin-1-ylethylamine

This impurity is considered relevant for the classification and labelling of the substance

PBT status:

the substance is not PBT / vPvB

Justification:

The available evidence on degradation, bioaccumulation potential, and toxicity for aminoethyl piperazine and its impurities indicate that the criteria for persistence (P) and toxicity (T) are met, while the criteria for bioaccumulation potential (B) is not met. Based on the information described below for the relevant endpoints, aminoethyl piperazine is considered as not PBT/vPvB.

Persistence assessment: Aminoethyl piperazine is not susceptible to hydrolysis, and does not absorb light at wavelengths which could result in direct photolytic degradation. Biodegradation is expected to be the dominant process affecting fate and lifetime of the substance in the environment. However, little or no biodegradation of aminoethyl piperazine has been observed in the OECD screening tests of ready and inherent biodegradability or their equivalents. However, the key study conducted according to OECD 301F (The Dow Chemical Company, 2010a) has shown the substance to be toxic or inhibitory to the activated sludge inoculum at a concentration of 30 mg/L. Therefore, the negative results of these screening tests may be due, in part, to inhibition of the microbial inocula by the relatively high concentrations of test substance employed. Under the test conditions, aminoethyl piperazine, is not readily biodegradable, and therefore it meets the screening criteria for “P”. 

Bioaccumulation assessment: The log octanol-water partition coefficient (log Kow) of the main constituent, aminoethyl piperazine, is -1.48 at 20 °C. Based on this low Kow value, aminoethyl piperazine is not expected to bioaccumulate. The measured bioconcentration factor (BCF) for similar substances (piperazine and diethylenetriamine) in carp (Cyprinus carpio) were < 6.3 L/kg, supporting this conclusion.

Toxicity assessment:

Acute toxicity tests for fish, daphnids, and aquatic algae were conducted for aminoethyl piperazine. Based on the inherent toxicity of the compound and disregarding toxicity studies that did not adjust to a neutral pH, the selected key studies for fish, daphnids, and algae reported toxicity values of 2190 mg/L (96 -hour LC50 for fathead minnows), 58 mg/L (48 -hour EC50 for Daphnia magna), and >1000 mg/L (EC50 for algae based on growth rate). Of these toxicity values, the 58 mg/L EC50 for Daphnia magna was the lowest value reported. Further more, the NOEC value in a 72 hour algal growth inhibition test with S. capricornutum was 31 mg/L. The results of these aquatic toxicity tests indicate that aminoethyl piperazine does not meet the criteria for “T”.

For the assessment of genotoxicity, five in vitro (three key and three supporting studies) and one in vivo study were identified for aminoethylpiperazine, and the weight of evidence on the mutagenicity from in vitro and in vivo testing indicates that no classifiication for genotoxicity is required for aminoethyl piperazine. 

In addition, no related effects on reproductive performance, gestation length, parturition, reproductive organs, or neurobehavioral parameters were noted in a screening level reproductive toxicity test with aminoethyl piperazine dosed at concentrations up to 8000 ppm (WIL Research Laboratories, 2010). 

In an OECD 414 rat developmental study in rats there was no effect on embryofetal development or survival detected at any dose level (0, 100, 300, or 1000 mg/kg/day); therefore, the embryofetal no observed effect level (NOEL) was considered to be 1000 mg/kg/day. However in an OECD 414 rabbit study AEP is considered a developmental toxicant due to post-implantation loss at the high dose group (150 mg/kg/day). Therefore AEP is classifiable as a Catagory 2 reproductive/developmental toxicant under GHS.

In a OECD 413 90 day inhalation study, rats were exposed to concentrations of 0, 0.2, 5.1, or 53.5 mg AEP/m3.  The 13-week point-of-contact NOEC was determined to be 0.2 mg AEP/m3. For the respiratory tract, exposure-related lesions in the larynx, trachea and lungs were observed in rats exposed to 53.5 mg AEP/m3.  Based on these findings the appropriate hazard classification is a Specific Target Organ Toxicity Repeat Exposure category 1 (STOT RE 1).

Under these testing criteria, aminoethyl piperazine is considered "T".

Aminoethyl piperazine does not contain impurities that are considered as PBT / vPvB.

Likely routes of exposure:

Emission characterization is not required for substances that are not PBT/vPvB.