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Administrative data

Description of key information

Tartaric acid and its salts does not have significant acute toxicity.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
Database does not contain data obtained by means of tests in accordance with standard testing guidelines; however, it is constituted by many data which are consistent about the absence of significant acute toxicity.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
A complete database is available for the acute toxicity by subcutaneous route. Although it does not contain data obtained by means of tests in accordance with standard testing guidelines, it is constituted by many data which are consistent about the absence of significant acute toxicity. Therefore, further investigation by dermal route are deemed to be not needed.

Additional information

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).


Justification for selection of acute toxicity – oral endpoint
This study has been selected since it is well documented. Overall, the assessment of the acute oral toxicity of tartaric acid and its salts are based on the weight of evidence of the available data.

Justification for selection of acute toxicity – dermal endpoint
Several data are available about the acute toxicity by subcutaneous route. This study has been selected since it is well documented. Overall, the assessment of the acute oral toxicity of tartaric acid and its salts are based on the weight of evidence of the available data.

Justification for classification or non-classification

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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