Registration Dossier

Administrative data

Description of key information

Based on the reported acute oral LD50 values for sodium fluoride in experimental animals, fluoride salts are considered moderately toxic if ingested.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
148.5 mg/kg bw

Additional information

In the key acute oral toxicity studies (Proctor & Gamble, 1984, 1985), the LD50 for sodium fluoride in male Sprague-Dawley rats was reported to be 223 mg/kg body weight with 95% confidence limits of 177 - 272 mg/kg body weight and the LD50 for sodium fluoride in female Sprague-Dawley rats was reported to be 148.5 mg/kg body weight with 95% confidence limits of 116.3 - 185.5 mg/kg body weight, respectively. The acute oral LD50 for ammonium fluoride in Sprague-Dawley rats was reported (Riedel-de Haen AG, 1994) to be greater than 25 mg/kg body weight, but less than 2000 mg/kg body weight.

Justification for classification or non-classification

According to EU classification, labelling and packaging of substances and mixtures (CLP) regulations (EC no 1272/2/2008), fluorides should be classified as acute toxic class 3 for acute oral toxicity.