Registration Dossier

Diss Factsheets

Classification & Labelling & PBT assessment

PBT assessment

Currently viewing:

Administrative data

PBT assessment: overall result

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

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.



1. Persistence assessment


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


1.1.Overall degradability

The 28days closed bottle test was performed in accordance with OECD 301D guidelines, to determine its biodegradability nature. All the study parameters and validity criteria were followed. Based on biochemical oxygen demand, after 28 days of exposure, the degradation was determined to be 88.19%, which suggest that test chemical is readily biodegradable in water. This study was supported by various degradation studies which correspondingly claims that test chemical is 100% degradable.

By relying on obtained results test chemical is considered to be readily biodegradable in nature. Based on the ANNEX XIII, of PBT classification criteria, test chemical cannot be classified Persistent chemical.          


2. Bioaccumulation assessment


The tested substance doesn’t meet the B criterion within Annex XIII based on the assessment that here follows:

On the basis of the available data from various experimental & modelling studies, the partition coefficient (log Kow) value of the test chemical was determined to be in range -1.59 to -1.29. Suggesting, chemical to possess hydrophilic in nature.

The obtained log Kow value is lower than the threshold value 4.5. It is expected that test chemical doesn’t have potential to accumulate in the visceral organs of aquatic species, classifying it to be not bio accumulative chemical.

Toxicity assessment


The tested substance does meet the T criterion within Annex XIII based on the assessment that here follows:


3.1. Mammals


It is evident from the results that test chemical can induce reproductive toxicity, and classified as category 2 according CLP classification criteria. Thus chemical can be categorised into Toxic chemical as per ANNEX XIII of PBT classification.


3.2. Freshwater organisms

Investigations were carried on various fresh water organisms which includes vertebrates, invertebrate and algae. Upon exposing to test chemical for the fixed exposure duration, the outcomes revealed that test chemical does not have tendency to induce any adverse effect on any tropic levels. These results (ranging from 75 – 1450 mg/L for short term studies, and 4.12-6.87 mg/L for long term studies) suggests that test chemical cannot be classified as per CLP classification criteria. Based on the higher NOEC values obtained in long term toxicity testing, test chemical cannot be classified into T as per Annex XIII for PBT classification. 


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.

Categories Display