Registration Dossier

Administrative data

Description of key information

The substance is of low acute toxicity by the oral route, with LD50 values of >2000 to >5000 mg/kg bw reported.  An acute inhalation LC50 of >5.07 mg/L is reported.  A waiver is proposed for acute dermal toxicity.  The acute intraperitoneal toxiicty of the substance is also low; LD50 values of >2000 mg/kg bw are reported in the mouse.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
5.07 mg/m³

Additional information

Acute oral toxicity

The results of an acute oral toxicity study report an acute oral LD50 value of 4250 mg/kg bw in the rat (Tarasenko et al, 1977). Another older study (Simonin & Pierron, 1937) reports an oral LD50 value of >5000 mg/kg bw in the guinea pig. The low toxicity of the substance is confirmed in a modern guideline-compliant limit dose study in the rat (Cords & Lammer, 2010), which reports an LD50 of >2000 mg/kg bw.

Acute inhalation toxicity

The acute inhalation toxicity of calcium fluoride was studied by nose-only exposure of one group of five male and five female rats for a 4 hour period. The test atmosphere contained calcium fluoride dust (MMAD 2.8 um) at the limit concentration of 5.07 g/m3. After exposure the animals were kept for a 14-day observation period, then necropsied. Treatment-related effects seen during exposure were limited to a slightly decreased breathing rate in two animals. No further abnormalities were detected during after exposure or during the 14 day observation period. A low overall body weight gain was seen in females. At necropsy, treatment related macroscopic changes were limited to red/pink discolouration of the lungs in two females. The 4-hour LC50 value of calcium fluoride dust was found to be greater than 5.07 g/m3 for both sexes under the conditions of this study (Mommers, 2002).

Acute dermal toxicity

No data are available: a waiver is proposed for this data requirement. Calcium fluoride is shown to be of inherently low toxicity by the oral, inhalation and intraperitoneal routes. Dermal absorption is also likely to be insignificant for this inorganic salt of low solubility, therefore it can be reliably predicted that the acute dermal toxicity of the substance will be very low. A study of acute dermal toxicity is scientifically unjustified and additionally cannot be supported for reasons of animal welfare.

Acute intraperitoneal toxicity

A single dose of calcium fluoride was administered by intraperitoneal injection to gravid female mice on day 9 of gestation at dose levels of between 25 and 6400 mg/kg bw. The acute intraperitoneal LD50 of calcium fluoride in gravid female mice was calculated to be 2778 mg/kg bw under the conditions of this study (Stratmann et al, 1979); the same authors report an LD50 value of 2638.27 mg/kg bw in a later paper (Stratmann & Eifinger, 1981), this value may represent a re-interpretation of the same data.

Justification for classification or non-classification

The substance is of low acute toxicity by the oral, inhalation and intraperitoneal routes and low acute dermal toxicity can be reliably predicted. No classification is proposed for acute toxicity according to the CLP regulation (1272/2008/EC).