Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Dose descriptor:
NOAEL
665.5 mg/kg bw/day
Additional information

Read across:

Based on the experimental results obtained with the analogue Citric acid on rats daily treated by feed for several months (NOAEL for reproductive effects = 600 mg/kg bw/day; LOAEL > 600 mg/kg bw/day for the same effects), and the molecular weights, the read-across approach was applied and the NOAEL with the substance Sodium diacetate is calculated to be 665.5 mg/kg bw/day, and LOAEL higher than 665.5 mg/kg bw/day for reproductive effects.

Based on the experimental results obtained with the analogue Citric acid (NOAEL >= 2500 mg/kg bw/day in rats (basis for effect: number of pregnancies, number of young born, or survival of young animals)), and the molecular weights, the read-across approach was applied and the NOAEL with the substance Sodium diacetate is calculated to be equal or greater than 2274 mg/kg bw/day for studied effects.

Based on the experimental results obtained with the analogue Citric acid, sodium salt, on rats daily treated by feed for several months (NOAEL for reproductive effects = 50 mg/kg bw/day; LOAEL > 50 mg/kg bw/day for the same effects), and the molecular weights, the read-across approach was applied and the NOAEL with the substance Sodium diacetate is calculated to be 50 mg/kg bw/day, and LOAEL greater than 50 mg/kg bw/day for reproductive effects.


Short description of key information:
Effects on fertility: Weight of evidence: Read-across from experimental results on rats and mice treated with Citric Acid and Citric Acid, sodium salt. No toxicity to reproduction was observed in any case.

Effects on developmental toxicity

Description of key information
Developmental toxicity/Teratogenicity: Weight of evidence: Read-across from experimental results on rats, mice, and rabbits treated with Sodium Acetate, Citric Acid, Calcium Formate and Acetic Acid. No maternal or developmental toxicity was seen in treated animals exposed to high doses of these substances.
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
1 185 mg/kg bw/day
Additional information

Based on the experimental results with Acetic acid (NOAEL >= 1600 mg/kg bw/day for maternal toxicity), and Sodium acetate (no maternal toxicity was observed at a 1000 mg/kg bw/day) ), the read-across approach is applied according to the TUS method

(Sprague J.B., 1970), and the NOAEL for maternal toxicity of Sodium diacetate is calculated to be equal or greater than 1185 mg/kg bw/day.

Read across based on the molecular weights comparison between the molecules: Based on the experimental results obtained with the analogue Citric acid (NOAEL >= 2500 mg/kg bw/day in mice and in rats (basis for effect: number of pregnancies, number of young born, or survival of young animals)), and the molecular weights, the read-across approach was applied and the NOAEL with the substance Sodium diacetate is calculated to be equal or higher than 2774 mg/kg bw/day for studied effects.

Based on the experimental results obtained with the analogue Calcium formate (NOAEL >= 200 mg/kg bw/day in Wistar rats for maternal and developmental toxicity), and the molecular weights, the read-across approach was applied and the NOAEL with the substance Sodium diacetate is calculated to be equal or higher than 218.5 mg/kg bw/day for maternal and developmental toxicity.

Justification for classification or non-classification

Sodium diacetate is not classified as dangerous for reproduction.