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Description of key information

Repeated dose toxicity: oral:
Weight of evidence. Experimental results from no-standard studies on rats with Sodium Acetate and Citric acid, sodium salt. All these studies showed no signs of toxicity, eventhough in one study, exceeding the limit dose.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
3 600 mg/kg bw/day
Study duration:
subacute
Species:
rat

Additional information

Repeated-dose toxicity: oral:

Experimental results from non-standard studies with Sodium Acetate and Citric acid, sodium salt.

In the publication reported by Cory-Slechta DA (1986), male rats were chronically treated for 8 months via drinking water with 50 or 500 ppm (0.005 or 0.05 mg/kg bw/day) Sodium Acetate from weaning. No effects were mentioned on survival, reinforcement behaviour or body weight gain.

In the second paper, reported by Dryden LP et al. (1971), effects of Sodium Acetate were studied on male Wistar rats daily treated for 4 weeks by feed with ca. 3600 mg/kg bw/day. No effects on growth or survival were observed at this dose.

In the third publication, reported by Goldman M (1981), male Long-Evans rats received daily 0 or 21 mg/kg bw/day Sodium Acetate in the diet. The investigation was terminated 3 months later and several indices of thyroid function examined. The reported effects cannot be considered as being clearly adverse. This study is considered to be of limited use in evaluating the toxicity of the substance.

In the study reported by Massaro EJ et al. (1986), Sodium Acetate was daily administered to male Wistar rats by drinking water for 112 days beginning at weaning (day 21 postpartum). Training for the latent learning task began on day 143 for the young adults. No evidence of impairment of simple task performance was observed. This study is also considered to be of limited use in evaluating the toxicity of the substance. The NOAEL was equal or greater than 0.01 mg/kg bw/day.

The last study, reported by Bonting SL et al. (1956) was performed with the analogue substance Citric acid, sodium salt. Albino rats were maintained on diets to which citric acid, sodium salt was added in a quantity that represented, on the basis of body weight, the maximum daily intake of acid that would be possile if the entire daily caloric requirements were obtained solely from the sugar contained in soft drinks.

No harmul effects were produced by the acid diet in two successive generations of animals maintained on this diet for a considerable part of the life span, as shown by an extensive study of growth, reproduction, the blood picture, the gross and microscopical appareance of the organs, the mineral and nitrogen metabolism and the tissue composition. The NOAEL was equal or greater than 50 mg/kg bw/day (nominal in diet).

Based on these results obtained with the analogue Citric acid, sodium salt and the molecular weights, the read-across approach was applied and the NOAEL with the substance Sodium acetate is calculated to be equal or greater than 57.44 mg/kg bw/day.

Justification for classification or non-classification

Repeated dose toxicity:

Oral: NOAEL>100mg/kg bw: non- classification