Registration Dossier

Administrative data

Endpoint:
repeated dose toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:

Data source

Materials and methods

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Potassium sodium tartate, like other potassium or sodium salts of tartaric acid has very low Kow, a very high water solubility (> 100 g/L) and is is mostly ionised at phisiological pH. According to the description made in section 7.1. and to the indication in part 7a of the CSR Guidance Document, passage through the stratum corneum of the skin of this substance is very unlikely. Taking into account that the substance has very low toxicity and is rapidly degraded or excreted, the performance of dermal toxicity tests is not warranted. In addition, and as supported information, no toxic effect whatsoever was appreciated after dermal exposure of two rabbits to a single dose of 0.5 g/ animal for a total of 4 hours. Thereby it is not considered justified to perform a dermal toxicity test, although it is recognised that dermal exposure during manufacture and handling cannot be excluded.
Executive summary:

Potassium sodium tartate, like other potassium or sodium salts of tartaric acid has very low Kow, a very high water solubility (> 100 g/L) and is is mostly ionised at phisiological pH. According to the description made in section 7.1. and to the indication in part 7a of the CSR Guidance Document, passage through the stratum corneum of the skin of this substance is very unlikely. Taking into account that the substance has very low toxicity and is rapidly degraded or excreted, the performance of dermal toxicity tests is not warranted. In addition, and as supported information, no toxic effect whatsoever was appreciated after dermal exposure of two rabbits to a single dose of 0.5 g/ animal for a total of 4 hours. Thereby it is not considered justified to perform a dermal toxicity test, although it is recognised that dermal exposure during manufacture and handling cannot be excluded.