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PBT assessment

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PBT assessment: overall result

Reference
Name:
ethylenediamine, salt with phosphoric acid
Type of composition:
boundary composition of the substance
State / form:
solid: bulk
Reference substance:
ethylenediamine, salt with phosphoric acid
PBT status:
the substance is not PBT / vPvB
Justification:

Classification of ethylenediamine, salt with phosphoric acid for effects in the environment:

 

The chemical ethylenediamine, salt with phosphoric acid (CAS no. 14852-17-6) is used as a flame retardant for polymers, plastics etc. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for ethylenediamine, salt with phosphoric acid. The PBT criterion was herein assessed based on experimental data in conjunction with standardized environmental fate 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

28-days Closed Bottle test following the OECD guideline 301 D to determine the ready biodegradability of the test item. The study was performed at a temperature of 20°C. The test system included control, test item and reference item. Polyseed were used as a test inoculum for this study. The concentration of test and reference item (Sodium Benzoate) chosen for both the study was 4 mg/L, while that of inoculum was 32 ml/l. OECD mineral medium was used for the study. The % degradation of procedure control (reference item) was also calculated using BOD & ThOD and was determined to be 85.54%. Degradation of Sodium Benzoate exceeds 67.46% on 7 days & 73.49% on 14th day. The activity of the inoculum is thus verified and the test can be considered as valid. The BOD28 value of test chemical was observed to be 0.37 mgO2/mg. ThOD was calculated as 0.5 mgO2/mg. Accordingly, the % degradation of the test item after 28 days of incubation at 20 ± 1°C according to Closed Bottle test was determined to be 74%. Based on the results, the test item, under the test conditions, was considered to be readily biodegradable in nature.

 

Thus, based on the available information, it indicates thatchemical ethylenediamine, salt with phosphoric acid is considered to be readily biodegradable in water and thus likely to be not persistent (P) in nature.

 

Bioaccumulation assessment

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

 

Theoctanol water partition coefficient of the test chemical was determined to be 1.865 at 25°C, which is less than the threshold of 4.5.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

All of the available short-term eco-toxicity data for fish, invertebrates and algae for the substance ethylenediamine, salt with phosphoric acidindicates the LC50/EC50 value was determined to be ranges from ≥ 12.5 to >400 mg/l. These value suggest that the substance is likely to be hazardous to Aquatic organisms at environmentally relevant concentrations. Since, the test chemical is readily biodegradable in water, chemical is considered as non-toxic to aquatic organisms and thus considered to be ‘not classified’ as per the CLP regulation.

 

On the basis ofthe various experimental studies of longterm eco-toxicity data for fishof the structurally and functionally similar read across chemical and applying the weight of evidence approach, the LC50 value was determined to be ranges from 250 to 440 mg/l, respectively and on the basis ofthe available data oflong term eco-toxicity data for aq. invertebrates of test chemical ethylenediamine, salt with phosphoric acid, the EC50 value was determined to be 1.1mg/l. These value suggest that the substance is not likely to be hazardous to aquatic organisms at environmentally relevant concentrations.

 

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.