Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

Currently viewing:

Administrative data

PBT assessment: overall result

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

Based on the assumption that in dilute aqueous conditions of defined pH, a salt will be fully dissociated and will behave no differently to the parent acid at identical concentration of the particular speciated form present, PBT assessment of tartaric acid salts (i.e. monosodium, monopotassium, sodium potassium, sodium, potassium and calcium tartrate) may be assessed using also data specific for tartaric acid.

Several studies are available in the scientific literature which investigated the biodegradation in water of tartaric acid and sodium tartrate. Almost all results support the ready biodegradation of these substances. Based on the assumption that in dilute aqueous conditions of defined pH, a salt will be fully dissociated and will behave no differently to the parent acid at identical concentration of the particular speciated form present, the biodegradability of tartaric acid salts (i.e. monosodium, monopotassium, sodium potassium, sodium, potassium and calcium tartrate) may be assessed using also data specific for tartaric acid. Overall, tartaric acid and its salts are deemed to be readily biodegradable in water.

It is expected that tartaric acid and its salts have a low potential for bioaccumulation due to the log Kow that is ≤ 3.

Tartaric acid was not found significant toxic to neither aquatic invertebrates nor aquatic algae. Furthermore, data predicted by valid QSAR models allow to estimate its toxicity to fish and aquatic microorganisms.  Based on the assumption that in dilute aqueous conditions of defined pH, a salt will be fully dissociated and will behave no differently to the parent acid at identical concentration of the particular speciated form present, the aquatic toxicity of tartaric acid salts (i.e. monosodium, monopotassium, sodium potassium, sodium, potassium and calcium tartrate) may be assessed using data specific for tartaric acid. Therefore, also the tartaric acid salts are deemed to be non-toxic to aquatic environment.

Tartaric acid and its salts are not classified as carcirogenic, mutagenic or toxic for reproduction according to Directive 67/548/EEC or carcinogenic, germ cell mutagenic or toxic for reproduction according to Regulation EC No 1272/2008.

For tartaric acid and its salts there is no evidence of chronic toxicity, as identified by the classification T, R48 or Xn, R48 according to Directive 67/548/EEC or specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation EC No 1272/2008.