Registration Dossier

Administrative data

Endpoint:
carcinogenicity
Data waiving:
other justification
Justification for data waiving:
other:
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Monosodium L(+)-tartrate toxicity in two year dietary feeding to rats
Author:
Hunter B, Batham P, Heywood R, Street AE % Prentice DE
Year:
1977
Bibliographic source:
Toxicology, 8: 263-274

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies)

Results and discussion

Applicant's summary and conclusion

Executive summary:

Monosodium L(+)-tartrate was fed to rats in their diet for a total of two years at levels of 25600, 42240, 60160 and 76800 ppm. There were no adverse clinical signs and the investigation of the animals' eyes, blood and urine did not reveal any reaction to treatment, nor were changes related to treatment seen in the macroscopic pathology or organ weights of rats killed after 104 weeks. Histological examination of the tissues did not show evidence of toxicity or tumour induction that could be attributed to treatment with monosodium L(+)-tartrate. Only the survival of rats receiving 42240, 60160 or 76800 ppm was superior to that of the controls and probably correlated with the lower food intake of these groups and the resultant reduced bodyweight gain.