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Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

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

Classification of Methyltrioctylammonium chloride for effects in the environment:

 

The chemical Methyltrioctylammonium chloride(CAS no. 5137-55-3) is usedas a catalyst in antioxidant, metal extraction agent, phase transfer catalyst, and surfactant. It is also used as an inert ingredient in non-food pesticide products; used in high performance liquid chromatography for the separation of tRNA.The aim was to assess whether the PBT criterion within Annex XIII was fulfilled forMethyltrioctylammonium chloride. 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

42-days Closed Bottle test following the OECD guideline 301 D to determine the ready biodegradability of the test item Methyltrioctylammonium chloride (CAS No.5137 -55 -3) (Experimental study report, 2018). The study was performed at a temperature of 20°C. The test system included control, test item and reference item. Polyseed were used for this study. 1 polyseed capsule were added in 500 ml D.I water and then stirred for 1 hour for proper mixing and functioning of inoculum. This gave the bacterial count as 107 to 108 CFU/ml. At the regular interval microbial plating was also performed on agar to confirm the vitality and CFU count of microorganism. The concentration of test and reference item (Sodium Benzoate) chosen for both the study was 4 mg/L, while that of inoculum was 32 ml/l. OECD mineral medium was used for the study. ThOD (Theoretical oxygen demand) of test and reference item was determined by calculation. % degradation was calculated using the values of BOD and ThOD for test item and reference item. The % degradation of procedure control (reference item) was also calculated using BOD & ThOD and was found to be 79.51%. Degradation of Sodium Benzoate exceeds 34.33% on 7 days & 61.44% on 14th day. The activity of the inoculum was thus verified and the test can be considered as valid. The BOD42 value of test chemical Methyltrioctylammonium chloride was observed to be 0.62 mgO2/mg. ThOD was calculated as 2.96 mgO2/mg. Accordingly, the % degradation of the test item after 42 days of incubation at 20 ± 1°C according to Closed Bottle test was determined to be 20.94%. Based on the results, the test item, under the test conditions, was considered to be primary inherently biodegradable in nature.

 

As thetest chemicalMethyltrioctylammonium chlorideis considered to beprimary inherently biodegradable, it can be concluded thatchemicalMethyltrioctylammonium chlorideis likely to be not persistent (not 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 estimated BCF value from authoritative database was evaluated to beranging from 58.4 to 221, 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 fulfils 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 data for fish, invertebrates and algae for the substanceMethyltrioctylammonium chlorideindicates the LC50/EC50 value to be in the range 0.0097 to 0.56 mg/L, respectively and on the basis of long term eco-toxicity data for toxicity to aq. algae, the EC50 and EC100 value was determined to be <0.5 mg/l and 0.5 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 ‘Aquatic Acute Category 1’ and ‘Aquatic Chronic Category 1’ as per the CLP regulation.

 

The chemical was therefore 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 T criterion but does not fulfil the P and B criterion and has therefore not been classified as a PBT compound within Annex XIII.