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PBT assessment

PBT assessment: overall result

PBT status:

the substance is not PBT / vPvB

Justification:

Classification of 2,2',2''-[(Methylsilanetriyl)tris(oxy)] tripropanamine for effects in the environment:

The chemical 2,2',2''-[(Methylsilanetriyl)tris(oxy)] tripropanamine (CAS no. 2399457-62-4) is used as a processing regulator etc. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for 2,2',2''-[(Methylsilanetriyl)tris(oxy)] tripropanamine. 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:

Environmental fate
According to the fugacity model levels III, the most likely environmental fate for this test chemical is soil (i.e. estimated to 83.1%). The half-life in soil (75 days estimated by EPI suite) indicates that the chemical is not persistent in soil and the exposure risk to soil dwelling animals is moderate to low.

If released in to the environment, 10.1% of the chemical will partition into water according to the Mackay fugacity model level III in EPI suite version 4.1 (2017). However, the half-life (37.5 days estimated by EPI suite) indicates that the chemical is not persistent in water and the exposure risk to aquatic animals is moderate to low.

Moreover, its persistent characteristic is only observed in the sediment compartment but Fugacity modelling shows that sediment is not an important environmental fate (less than 8% i.e. reported as 6.76% when estimated by EPI Suite version 4.1).

Hence it has been concluded that chemical 2,2',2''-[(Methylsilanetriyl)tris(oxy)] tripropanamine is not persistent in nature.

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

The estimated BCF value from authoritative database was determined to be 3.162 L/Kg, respectively and the octanol water partition coefficient of the test chemical was determined to be 1.682±0.003 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 classified for reprotoxicity, Further, the tested chemical is regarded to be not classified for carcinogenicity and mutagenicity.
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, aq. invertebrates and algae for the substance 2,2',2''-[(Methylsilanetriyl)tris(oxy)] tripropanamine (CAS no. 2399457-62-4) indicates the LC50/EC50 value to be >100 mg/L.

There are no available long-term toxicity evaluations for chemical 2,2',2''-[(Methylsilanetriyl)tris(oxy)] tripropanamine. By speculation, long-term NOEC for aquatic organisms were not expected for the substance at concentration below 0.01 mg/L based on the data mentioned above.

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.