Aluminium tristearate

PBT assessment

PBT assessment: overall result

PBT status:

the substance is not PBT / vPvB

Justification:

Classification of Aluminium tristearate for effects in the environment:

 

The chemical Aluminium tristearate (CAS no. 637-12-7) is used for in chemical syntheses, as a laboratory agent and for cosmetic application. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for Aluminium tristearate. 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 fulfils 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 87.1%). In soil, the substance was expected to have negligible mobility based upon a Log KOC of 10. The half-life in soil (120 days estimated by EPI suite) indicates that the chemical is persistent and the exposure risk to soil dwelling animals is moderate to high.

 

If released in to the environment, 12.8 % of the chemical will partition into water according to the Mackay fugacity model level III in EPI suite version 4.1 (2016). However, the half-life (60 days estimated by EPI suite) indicates that the exposure risk to aquatic animals is moderate.

 

Moreover, its persistent characteristic is also observed in the sediment compartment but Fugacity modelling shows that sediment is not an important environmental fate (less than 1% when estimated by EPI Suite version 4.1).

 

Hence it has been concluded that Aluminium tristearate is persistent in nature.  

 

Although the half-life values suggest classification as very persistent (vP), the substance is classified only as persistent (P) since only estimated half-life values are available for the same. Hence it has been concluded that Aluminium tristearate is 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 bioaccumulation factor (BCF) was determined to 3.162 L/kg wet wt. 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

As per Column 2 (Annex VII and VIII) of the REACH regulation, a study does not need to be conducted if there are mitigating factors indicating that aquatic toxicity is unlikely to occur for instance if the substance is highly insoluble in water (solubility: 0.00000000000000000009386 mg/L). 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 fulfils the P criterion but does not fulfil the B and T criterion and has therefore not been classified as a PBT compound within Annex XIII.