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PBT assessment

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PBT assessment: overall result

Reference
Name:
1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-,N-coco acyl derivs.,hydroxides, inner salts
Type of composition:
boundary composition of the substance
State / form:
liquid
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

Classification of 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner saltsfor effects in the environment:

 

The chemical 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts (CAS no. 61789-40-0) is used as a surfactant in shampoos and soaps & as an emulsifier and thickener in cosmetics. It is used as an intermediate and surfactant in soap, cleaning compound manufacture and in commercial & consumer soaps and detergents. Also used in anti-static agents, corrosion inhibitors, cosmetics, foaming agents, pharmaceutical, surface-active agents, viscosity adjustors, cleaning/washing agents and disinfectants. It is used as foaming agent, thickener for personal care cleansers, mild shampoos, foam baths, detergents etc.. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts. 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 basisof the variousexperimental detailed biodegradation studies from several different reliable sources of the chemical 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts (CAS no. 61789-40-0) performed as per the OECD TG / other suitable test guidelines; chemical was considered to be readily biodegradable in waterand 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 be 83.1%). In soil,1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner saltswas expected to have moderate to slow mobility based upon a Log KOC value ranging from 2.156 to 2.81, respectively. 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, 16.5% 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 0.403% when estimated by EPI Suite version 4.1).

 

Hence it has been concluded that chemical 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts 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 databases was evaluated to beranges from 4.18 to 70.79, respectively and the octanol water partition coefficient of the test chemical was estimated to be -1.28, 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 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 data for fish, invertebrates and algae for the substance1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner saltsindicates the LC50/EC50 value to be in the range 1.84 to 48 mg/L, respectively and on the basis of long term eco-toxicity data for fish and aq. invertebrates, the NOEC value was determined to be ranges from 0.16 & 0.9 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 Chronic Category 3’ as per the CLP regulation.

 

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