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Diss Factsheets

Classification & Labelling & PBT assessment

PBT assessment

Administrative data

PBT assessment: overall result

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

Classification of Docosanoic acid for effects in the environment:

The chemical Docosanoic acid (CAS no. 112-85-6) isused in cosmetics, waxes, plasticizers, stabilizers and as a chemical intermediate. It is also used in lubricating oils and to retard solvent evaporation in paint removers etc.The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for Docosanoic 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

On the basis of various experimental results of biodegradation studies for the test chemical Docosanoic acid(CAS no. 112-85-6), it indicates that chemical Docosanoic acidcan be expected to be readily biodegradable in water and thus likely to be not persistent (not P) in nature.

 

Environmental fate

According to the fugacity model levels III, the most likely environmental fate for this test chemical is soil (i.e. estimated to 74.9%). In soil, Docosanoic acid was expected to have slow mobility based upon a Log KOC value 2.576. The half-life in soil (30 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, 24.1% 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 (15 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 0.226% when estimated by EPI Suite version 4.1).

 

Hence it has been concluded that chemical Docosanoic acid 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 upto 10, 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: < 0.016 mg/L at 25° C) and on the basis of all the available short-term eco-toxicity information for fish, aq. Invertebrates and aq. algae for the substance indicates the LC50/EC50 value was determined to be > 5.0 mg/L. Since, the test chemical Docosanoic acid is highly insoluble in water & as the toxic effect of chemical on test organism was not observed till the limit of solubility, the corresponding LC50/EC50 value cannot be used to classify the test chemical for aquatic toxicity. The chemical Docosanoic acid was therefore not considered as hazardous to aquatic environments as per the criteria set out in Annex XIII.

 

On the basis of the experimental study of long term eco-toxicity data for fish and aq. invertebrates, the both NOEC and LC50/EC50 value was determined to be ranges from > 0.84 to > 4.99 mg/l, respectively. No abnormal effect were observed till the last limit of solubility of test material in water. Hence , based on the above effect concentration it can be considered that test substance is not classified as per CLP criteria.

 

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.