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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

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

Classification of 1-methylpiperidin-4-ol for effects in the environment:

 

The chemical 1-methylpiperidin-4-ol (CAS no. 106-52-5) is used for pharmaceutical and chemical synthesis. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for 1-methylpiperidin-4-ol. 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 fulfils the P criterion within Annex XIII based on the assessment that here follows:

 

Biotic degradation

Estimation Programs Interface Suite (EPI suite, 2016) was run to predict the biodegradation potential of the test compound 4 -Piperidinol, 1 -methyl-(CAS no. 106 -52 -5).The screening test inherent to the biodegradability of the substance was calculated using the software BIOWIN v4.10. The results indicate that 4-Piperidinol, 1-methyl- is expected to be readily biodegradable.

 

Biodegradation study was conducted for evaluating the percentage biodegradability of read across substance N-Methyldiethanolamine (SIDS INITIAL ASSESSMENT PROFILE, CoCAM2, Pg. no. 17-19, April 2012). The study was performed according to OECD Guideline 301 A. The percentage degradation of test substance was determined to be 96% after 18 days. Thus, the substance N-Methyldiethanolamine is expected to be readily biodegradable in water.

 

On the basis of above results for target and read across substance, it can be concluded that the test substance 4-Piperidinol, 1-methyl-can be expected to be readily biodegradable 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 65.1%). In soil, 1-methylpiperidin-4-ol was expected to have rapid mobility based upon a KOC of 4.182. 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 low.

 

If released in to the environment 34.9 % 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 (15 days estimated by EPI suite) indicates that the exposure risk to aquatic animals is 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% when estimated by EPI Suite version 4.1). Hence it has been concluded that 1-methylpiperidin-4-ol 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 log octanol-water partition coefficient (log Kow) was determined to -0.14. 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

All of the available short-term eco-toxicity estimation for fish, invertebrates and algae for the substance as well as its read-across substances indicates the LC50/EC50 value are above 100 mg/L indicating that the substance is classified as non-hazardous as per the CLP criteria.These values suggest classification for aquatic toxicity will not be applicable for all of the tropic levels.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.