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PBT assessment

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PBT assessment: overall result

Reference
Name:
12-hydroxy-N-(2-hydroxyethyl)octadecan-1-amide
Type of composition:
boundary composition of the substance
State / form:
solid: particulate/powder
Reference substance:
12-hydroxy-N-(2-hydroxyethyl)octadecan-1-amide
PBT status:
the substance is not PBT / vPvB
Justification:

Classification of 12-hydroxy-N-(2-hydroxyethyl)octadecan-1-amide for effects in the environment:

 

The chemical 12-hydroxy-N-(2-hydroxyethyl)octadecan-1-amide (CAS no. 106-15-0) is used as an active pharmaceutical intermediate. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for 12-hydroxy-N-(2-hydroxyethyl)octadecan-1-amide. 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

Estimation Programs Interface Suite (EPI suite, 2018) was run to predict the biodegradation potential of the test compound 12-hydroxy-N-(2-hydroxyethyl)octadecan-1-amide (CAS no.  106 -15 -0) in the presence of mixed populations of environmental microorganisms. The biodegradability of the substance was calculated using seven different models such as Linear Model, Non-Linear Model, Ultimate Biodegradation Timeframe, Primary Biodegradation Timeframe, MITI Linear Model, MITI Non-Linear Model and Anaerobic Model (called as Biowin 1-7, respectively) of the BIOWIN v4.10 software. The results indicate that chemical 12-hydroxy-N-(2-hydroxyethyl)octadecan-1-amide is expected to be readily biodegradable.

 

Experimental results from the read across substances also indicate that they are readily biodegradable.

 

Thus, based on the available information, it indicates that chemical 12-hydroxy-N-(2-hydroxyethyl)octadecan-1-amide can be considered 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 77.2%). In soil,12-hydroxy-N-(2-hydroxyethyl)octadecan-1-amidewas expected to have moderate mobility based upon a Log KOC value of 1.801± 0.001at 25°C. 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, 21.9% 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 0.545% when estimated by EPI Suite version 4.1).

 

Hence it has been concluded that chemical 12-hydroxy-N-(2-hydroxyethyl)octadecan-1-amide is not persistent (not P) in nature.

 

Bioaccumulation assessment

The tested substance fulfils the B criterion within Annex XIII based on the assessment that here follows:

 

Theoctanol water partition coefficient of the test chemical was estimated to be ranges from 4.22 to 4.69, respectively. Since the logKow value goes to greater than the threshold of 4.5. If this chemical is released into the aquatic environment, there should be a high 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

On the basis of the various experimental studies of the structurally and functionally similar read across chemical (including the biodegradability of read across chemical) and applying the weight of evidence approach,the LC50/EC50 value for fishof the test chemical 12-hydroxy-N-(2-hydroxyethyl)octadecan-1-amide can be determined to be in the range 2.4 – 15 mg/L, respectively and all of the available short-term eco-toxicity data for aq. invertebrates and algae for the test chemicalindicates the LC50/EC50 value to be > 100 mg/L.. These value suggest that the substance is likely to be hazardous to Aquatic organisms. Since the test chemical is readily biodegradable in water, chemical can be considered as not hazardous to Aquatic organisms at environmentally relevant concentrations andthus can be considered to be ‘not classified’as per the CLP regulation.

 

There are no available long-term toxicity evaluations for 12-hydroxy-N-(2-hydroxyethyl)octadecan-1-amide. 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 fulfils the B criterion, but does not fulfil the P and T criterion and has therefore not been classified as a PBT compound within Annex XIII.