Registration Dossier
Registration Dossier
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EC number: 212-769-1 | CAS number: 868-14-4
Categories
- Category name:
- TSC - Tartaric Substances Category - Potassium hydrogen tartrate
Justifications and discussions
- Category definition:
- This category covers tartaric acid and its sodium, potassium and calcium salts. All different category members are based on the tartaric acid structure, which can be de-protonated up to 2 times. The category hypothesis is that all the members are various ionized forms of the tartaric acid. The main assumption is that the presence of sodium, potassium and calcium in the molecule is not significant in respect of all the properties under consideration.
- Category description:
- The properties of the category members dont't follow a specific pattern, but are similar.
- Category rationale:
- REPORTING FORMAT FOR THE CATEGORY APPROACH
1. CATEGORY HYPOTHESIS
This category covers tartaric acid and its sodium, potassium and calcium salts. The different salts are prepared by neutralizing the acid to a specific pH. All different category members are based on the tartaric acid structure, which can be de-protonated up to 2 times. The category hypothesis is that all the members are various ionized forms of the tartaric acid. The main assumption is that the presence of sodium, potassium and calcium in the molecule is not significant in respect of all the properties under consideration. In dilute aqueous conditions of defined pH a salt will behave no differently to the parent acid, at identical concentration of the particular speciated form present and will be fully dissociated. Hence some properties (measured or expressed in aqueous media, e.g. ecotoxicity) for a salt can be directly read-across (with suitable mass correction) to the parent acid and vice versa [1]. For irritation/corrosion properties, the acid is considered separately by its salts.
Another issue regards the stereochemistry of the substances; in particular, the secondary assumption is that, in absence of biological effects due to stereoselective interactions with chiral targets, data related to a specific stereoform of a molecule can be used to predict the same property for also its enantiomer and diastereoisomers by means of the read-across.
2. CATEGORY JUSTIFICATION
As specifically documented in each endpoint study summary in the registration dossier, tartaric acid and its salts show very similar behaviour with regard to their (i) physical and chemical properties, (ii) environmental fate, (iii) ecotoxicology and (iv) toxicology.
All substances range from soluble to very soluble in water. For all substances log Kow is negative from -5.14 for potassium hydrogen tartrate to -0.76 for tatraric acid.
3. APPLICABILITY DOMAIN OF THE CATEGORY
The category applies to tartaric acid and all of its possible sodium, potassium or calcium salts (like Calcium tartrate).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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