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PBT assessment

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PBT assessment: overall result

Reference
Name:
nicotine dihydrogen ditartrate
Type of composition:
boundary composition of the substance
State / form:
solid: particulate/powder
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

Classification of Nicotine dihydrogen ditartrate for effects in the environment:

The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for Nicotine dihydrogen ditartrate (CAS no. 65-31-6).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:

 

Biotic degradation

In a prediction using the Estimation Programs Interface Suite (2018), the biodegradation potential of the test chemical in the presence of mixed populations of environmental microorganisms was estimated. 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 test chemical is expected to be not readily biodegradable.

 

Experimental results from the read across substances also indicate that they are not readily biodegradable.

 

Thus, based on the available information, it indicates that chemical Nicotine dihydrogen ditartrate can be expected to be not readily biodegradable in water and thus likely to be persistent (P) in nature.

 

 

Bioaccumulation assessment

The tested substance does not fulfil the B criterion within Annex XIII based on the assessment that here follows:

 

The octanol water partition coefficient of the test chemical was estimated to be -6.54,respectively, which is less than the threshold of 4.5. 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 fulfils the T criterion within Annex XIII based on the assessment that here follows:

 

Mammals

The tested chemical is regarded to be classified for reprotoxicity in ‘Category 2‘ as per the CLP Regulation.

 

The tested chemical is regarded to be not classified for mutagenicity and carcinogenicity,

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 ofthe various experimental studies of shortterm eco-toxicity data for fish, aq. invertebrates and algaeof 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 was determined to be ranges from 1.39 to 90 mg/l, respectively. These value suggest that the substance is likely to be hazardous to aquatic organisms at environmentally relevant concentrations and can be considered to be classified in ‘Aquatic chronic category 2’ as per the CLP regulation.

 

There are no available long-term toxicity evaluations forchemicalNicotine dihydrogen ditartrate. By speculation, long-term NOEC for aquatic organisms were 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 P and T criterion, but does not fulfil the B criterion and has therefore not been classified as a PBT compound within Annex XIII.