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Description of key information

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
repeated dose toxicity: oral, other
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Justification for type of information:
Important considerations for the read-across were:
- calcium tartrate (the target chemical) has similar physico-chemical properties as the others members of the Category "Tartaric acids and its salts" (the source chemicals); these properties include molecular weight; logKow and solubility
- there are structural similarities between all the chemicals of the Category
- overall, it is believed that the tartaric acid and its salts possess similar profiles of systemic toxicity, therefore, the assessment of this endpoint may be jointly performed using all available data for these substances.
Remarks on result:
not determinable due to absence of adverse toxic effects
Key result
Critical effects observed:
no

The repeated dose toxicity of tartaric acid and its salt was assessed by oral route. According to Hunter et al. (1977), monosodium L(+) tartrate, given to rats in their diet for a total period of two years at dose levels of 25600, 42240, 60160 and 76800 ppm (equivalent to a tartaric acid dietary level of 20000, 33000, 47000 or 60000 ppm, respectively), did not cause adverse clinical effects. Moreover, the investigation of the animals' eyes, blood and urine did not reveal any reaction to treatment. In the same manner, no changes related to treatment were seen in the macroscopic pathology or in organ weights of the rats killed after 104 weeks. The histological examination of the tissues did not show any evidence of toxicity or tumour induction that could be attributed to treatment with monosodium L(+) tartrate.

Other studies showed adverse effects on renal function following repeated administration of tartaric acid or disodium tartrate. However, these effects were exclusively observed at very high doses and, therefore, they were judged as non-significant.

Overall, it is believed that the tartaric acid and its salts possess similar profiles of systemic toxicity, therefore, the assessment of this endpoint may be jointly performed using all available data for these substances. In conclusion, these substances do not deemed to be toxic following repeated administration.

Conclusions:
Tartaric acid and its salts possess similar profiles of systemic toxicity, therefore, the assessment of this endpoint may be jointly performed using all available data for these substances. In conclusion, these substances do not deemed to be toxic following repeated administration.
Executive summary:

The assessment of the potential repeated dose toxicity of Calcium tartrate was performed by means a read across based on grouping of substances (category approach). The name Category used is "Tartaric acid and its salts". The repeated dose toxicity of tartaric acid and its salt was assessed by oral route.

Overall, it is believed that the tartaric acid and its salts possess similar profiles of systemic toxicity, therefore, the assessment of this endpoint may be jointly performed using all available data for these substances. In conclusion, these substances do not deemed to be toxic following repeated administration.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
2 460 mg/kg bw/day
Study duration:
chronic
Species:
rat
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 toxicity of tartaric acid and its salts following repeated administration.

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Overall, it is believed that the tartaric acid and its salts possess similar profiles of systemic toxicity, therefore, the assessment of this endpoint may be jointly performed using all available data for these substances. In conclusion, these substances do not deemed to be toxic following repeated administration.

Justification for classification or non-classification

According to Regulation (EC) n. 1272/2008, the studies results indicate that the substances should not be classified for the specific target organ toxicity - repeated exposure because data are judged as "conclusive but not sufficient for classification".