Octadecyl stearate

PBT assessment

PBT assessment: overall result

PBT status:

the substance is not PBT / vPvB

Justification:

Classification of Octadecyl stearate for effects in the environment:

 

The chemical Octadecyl stearate (CAS no. 2778-96-3) is used as an ingredient in lubricants, resins, perfumes and cosmetics. Also used as an emollient, emulsifier & thickener in various ointments and is widely used as a hair coating in shampoos and hair conditioners etc.. It is also used as in surfactant   lubricants for manufacturing of food-contact metallic articles. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for Octadecyl stearate. 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 83.8%). In soil, Octadecyl stearate was expected to have negligible mobility based upon a Log KOC value ranging from 7.0 to 9.1, respectively. 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, 16% 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 1% i.e. reported as 0.000644% when estimated by EPI Suite version 4.1).

 

Hence it has been concluded that chemical Octadecyl stearate 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 3.2 L/Kg, respectively. 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 VIII) of the REACH regulation, testing for this end point is considered scientifically unjustified since there are mitigating factors indicating that aquatic toxicity is unlikely to occur as the substance is highly insoluble in water (solubility: 0.000000000002871 mg/L at 25° C).

 

There are no long term data on aquatic toxicity for the substance Octadecyl stearate (CAS no. 2778-96-3). 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.