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EC number: 213-067-8 | CAS number: 921-53-9
Tartaric acid and its salts does not have significant acute toxicity.
Acute Toxicity Data
The acute oral LD50 for compound FDA 71-55 (tartaric acid) is considered to be greater than 5000 mg/kg.
Animals which were fed oats or oats and cabbage succumbed to a dose of 0.4 gm. of the salt per kilo when given by subcutaneous injection, Suppression of urine was usually observed on the first day and death occurred in six to seven days. In starvation, slightly smaller doses were fatal to some rabbits. The resistance was increased considerably when the diet was changed to carrots, Such animals stood 1.0 gm. per kilo by subcutaneous injection, while 1.2-1.5 gm. per kilo were toxic. A moderate degree of tolerance for tartrates was induced in animals which were fed oats and cabbage. By gradually increasing the dose, a large proportion (6 out of 9) of rabbits survived 0.8 gm. per kilo which is twice the fatal dose. Rabbits which were receiving carrots did not acquire tolerance for tartrates.
Sodium tartrate showed different tolerance which depended on diet following subcutaneous administration.
The acute toxicity of tartaric acid and its salts was investigated by means of several tests principally performed by means of oral and subcutaneous administration. Almost all data support the absence of significant acute toxicity for both exposure routes. A single LD50 value of 920 mg/kg was observed for tartaric acid, in disagreement with all the others LD50 values for tartaric acid and its salts.
Overall, it is considered that the systemic acute toxicity of tartaric acid is similar to that ones of its salts (i.e. monosodium, monopotassium, sodium potassium, sodium, potassium and calcium tartrate) and, therefore, the assessment of these endpoints may be jointly performed using all available data for these substances. Therefore, tartaric acid and its salts are deemed to be not acutely toxic.
With regard to the specific target organ toxicity, adverse effects on kidney (i.e. nephritis) were reported in some tests. However, these effects were only observed at very high dose levels close to the lethal dose (> 2000 mg/kg bw).
According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the study results indicate that the substances should not be classified for acute oral toxicity because data are judged as "conclusive but not sufficient for classification".
According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the substances should not be classified for acute inhalation toxicity because of data lacking.
According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the study results indicate that the substances should not be classified for acute dermal toxicity because the data currently available are judged as "conclusive but not sufficient for classification".
According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, study results indicate that the substances should not be classified for specific target organ toxicity - single exposure because data are judged as "inconclusive".
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