Registration Dossier

Toxicological information

Endpoint summary

Currently viewing:

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Study duration:
chronic
Species:
rabbit
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 to the fertility of tartaric acid and its salts.
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Tartaric acid was investigated for its toxicity to the fertility in rabbits, mice, rats and hamsters. The substance did not affect the parameters related to the reproductive performance.

Based on the chemical structure, it is considered that the toxicity to reproduction of tartaric acid is the same of that ones of its salts (i.e. monosodium, monopotassium, sodium potassium, sodium, potassium and calcium tartrate) and, therefore, the assessment of this endpoint may be jointly performed using all available data for these substances.

Overall, tartaric acid and its salts do not have toxicity to reproduction.


Short description of key information:
Tartaric acid and its salts do not have toxicity to reproduction.

Justification for selection of Effect on fertility via oral route:
Although an endpoint study record has been selected, the assessment of the toxicity to the fertility is based on the weight of evidence since the available studies took into account different relevant parameters.

Effects on developmental toxicity

Description of key information
Tartaric acid and its salts (e.g. Calcium tartrate) do not have developmental toxicity.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Study duration:
subacute
Species:
mouse
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 developmental toxicity of tartaric acid and its salts.
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

Tartaric acid was investigated for its developmental toxicity in mice, rats and rabbits. The substance did not cause significant increases in skeletal abnormalities, fetal survival or in other parameters, compared with the controls.

Based on the chemical structure, it is considered that the toxicity of tartaric acid is the same of that ones of its salts (i.e. monosodium, monopotassium, sodium potassium, sodium, potassium and calcium tartrate) and, therefore, the assessment of this endpoint may be jointly performed using all available data for these substances.

Overall, tartaric acid and its salts do not have developmental toxicity.


Justification for selection of Effect on developmental toxicity: via oral route:
The study selected is exhaustively documented, it allows to evaluate the reliability of the test.

Justification for classification or non-classification

According to Regulation (EC) n. 1272/2008, the substances should not be classified for the toxicity to reproduction/development because the data are judged as "conclusive but not sufficient for classification".

Additional information