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PBT assessment

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PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

Classification of Tripiperazine dicitrate for effects in the environment:

 

Tripiperazine dicitrate (CAS no. 144-29-6) is used in veterinary medicine as an anthelmintic in pigs and poultry. The aim of the PBT assessment was to evaluate whether this chemical fulfils the PBT criterion within Annex XIII. The PBT assessment were based on toxicological information in conjunction with standardized environmental fate- and bioaccumulation models. Here follows a description of the PBT assessment.

 

 

Persistence assessment

The tested substance does not fulfil the P criterion within Annex XIII based on the assessment that here follows:

 

Biotic degradation

Estimation Programs Interface Suite (EPI suite, 2016) was run to predict the biodegradation potential of the test compound Piperazine citrate (CAS no. 144 -29 -6) in the presence of mixed populations of environmental microorganisms. The biodegradability of the substance was calculated using seven different models such as Linear Model, Non-Linear Model, Ultimate Biodegradation Timeframe, Primary Biodegradation Timeframe, MITI LInear Model, MITI Non-Linear Model and Anaerobic Model (called as Biowin 1-7, respectively) of the BIOWIN v4.10 software. The results indicate that Piperazine citrate is expected to be readily biodegradable.

 

Biodegradation study was conducted according to OECD TG 301 C guideline for evaluating the percentage biodegradability of read across substance Piperazine. Initial test substance conc. used in the study was 20 mg/l. Namely, a water, acetone or DMSO solution (0.1 ml) of the test chemicals was added to a mixture of river/sea water (4.9 ml) from an unpolluted area and an autoclaved solution (5.0ml) of 0.2% peptone in a sterile test tube with a tight plug. After sealed with film and fixed at an angle of 30°in a dark box, the test tubes were incubated at 30°C and shaked at 120rpm. Inoculum used for the study was mixed culture obtained from different sources (Sea water from Tama River and River water from Enoshima Beach). The percentage degradation of test substance was found to be 20% and 77% in 3 days, respectively. Thus, the substance Piperazine was determined to be readily biodegradable in nature.

 

 

Bioaccumulation assessment

The tested substance does not fulfil the B criterion within Annex XIII based on the assessment that here follows:

 

The BCF value is determined as 3.162 at 25ºC (EPI Suite, Version 4.1, 2011) and the log octanol-water partition coefficient (log Kow) was estimated as -1.15. If this chemical is released into the aquatic environment, there should be a low risk for the chemical to bioaccumulate in fish and food chains.

 

 

Toxicity assessment

The tested substance does not fulfil the T criterion within Annex XIII based on the assessment that here follows:

 

Mammals

The tested chemical is regarded to be not classified for carcinogenicity, mutagenicity and reprotoxicity, Further, there is no evidence of chronic toxicity, as identified by the classifications STOT (repeated exposure), category 1(oral, dermal, inhalation of gases/vapours, inhalation of dust/mist/fume) or category 2 (oral, dermal, inhalation of gases/vapours, inhalation of dust/mist/fume).

 

Aquatic organisms

Most of the available short-term eco-toxicity estimation for fish and invertebrates for the substance as well as its read-across substances indicates the LC50/EC50 value are above 100 mg/L indicating that the substance is classified as non-hazardous as per the CLP criteria.

The EC50 values for algae indicate that the substance can be classified as Aquatic Chronic 3 but since the substance is readily biodegradable and the partition coefficient (log Kow) of the test chemical is also not ≥ 4 (i.e, reported in range -1.15), test chemical can be considered as non-hazardous to aquatic organisms as per the CLP criteria.

 

In addition, the NOEC value for the read across substance in fish in a 7 day study was reported as 100 mg/L.These values suggest classification for aquatic toxicity will not be applicable for all of the tropic levels.The chemical was therefore not considered as hazardous to aquatic environments as per the criteria set out in Annex XIII.

 

 

Conclusion

Based on critical, independent and collective evaluation of information summarized herein, the tested compound does not fulfil the P, B and T criterion and has therefore not been classified as a PBT compound within Annex XIII.