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PBT assessment

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PBT assessment: overall result

Reference
Name:
Sodium Salicylate
Type of composition:
legal entity composition of the substance
State / form:
solid: bulk
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

Classification of Sodium salicylate for effects in the environment:

 

The chemical Sodium salicylate (CAS no. 54-21-7) is used as a denaturant and preservative. Also used as pharmaceutical intermediate.It is used as an analgesic and antipyretic. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled forSodium salicylate. 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 basis of various experimental results of biodegradation studies for the test chemicalSodium salicylate(CAS no. 54-21-7), it indicates thatchemicalSodium salicylatecan 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 67.6%). In soil,Sodium salicylatewas expected to have rapid mobility based upon a Log KOC value of 0.651, 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, 31.8% 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 0.087% when estimated by EPI Suite version 4.1).

 

Hence it has been concluded that chemical Sodium salicylate 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 database was determined to be ranges from 3.162 to 4.16, respectivelyand the octanol water partition coefficient of the test chemical was determined to be ranges from-1.259 to -1.49, 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 Reprotox Category 2 as per theSelf classification - Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation).

The tested chemical is regarded to be not classified for carcinogenicity, and mutagenicity, 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 test chemicalSodium salicylatethe LC50/EC50 value to be in the range 48.29 mg/l to 2160 mg/L, respectively. These value suggest that the substance is likely to be hazardous to aquatic organisms at environmentally relevant concentrations. Since the test chemical is readily biodegradable in nature, chemical can be considered as non-toxic to aquatic organisms at environmentally relevant concentrations and thus can be considered to be ‘not classified’ as per the CLP regulation.

 

On the basis ofthelong term eco-toxicity data for fish and aq. invertebrates, the NOEC value was determined to be ranges from 4.126 to 6.867 mg/l, respectively. 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 T criterion but does not fulfil the P and B criterion and has therefore not been classified as a PBT compound within Annex XIII.