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Administrative data

Description of key information

NOAEL (subchronic) for Sodium diacetate is calculated to be: 132 mg/kg/bw.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
132 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Additional information

Evaluation of the toxicity data, was realized according to the method of Toxic Unit Summation (TUS) published by Sprague J.B., Water Research, vol. 4, pp. 3-32, 1970).

Data used for the read across approach were extrapolated from experimental data according to the method of F. Kaberlach based on the result of NTP studies (Ann. Occup. Hyg. Vol, 46, Nº2, pp 175-185, 2002). The 28days NOAEL of Sodium acetate (3.600g/kg/bw) was extrapolated to be 1.125 g/kg/bw (subchronic) and the subchronic NOAEL for Acetic acid was 0.06g/kg/bw.

Based on these extrapolated values for Acetic acid and Sodium acetate, the read-across approach was applied, and the subchronic NOAEL for Sodium diacetate is calculated to be equal or higher than 132 mg/kg bw/day.

Validation of the choosen TUS method.

To validate the method, calculation of the Acute oral toxicity was done and was compared with experimental result.

Experimental LD50 for Sodium diacetate is 5.6 g/kg/bw. The LD50 for Sodium diacetate, calculated from LD50 of Acetic acid and LD50 of Sodium acetate using TUS method is 3.805 g/kg/bw. As it can be easily seen, the calculated result is situated inside of 50% deviation range of the experimental result and according to the principles of Sprague method such result (inside of 50% of deviation range) is considered as valid.

Justification for classification or non-classification

EC50> 100 mg/kg/bw; non-classified.