Aluminium fluoride

Endpoint summary

Description of key information

Aluminium fluoride is of low acute toxicity following oral exposure.  The minimum lethal oral dose of AlF3 in rats was determined to be greater than 2000 mg/kg body weight in an OECD guideline and GLP-compliant study (Test No. 420) (Bollen, 2001).  No treatment-related effects were observed in all parameters examined.  In the IUCLID Dataset for aluminium fluoride as reported by the European Commission European Chemicals Bureau (2000), the minimum lethal oral dose of AlF3 in guinea pigs was determined to be equal to or greater than 600 mg/kg body weight; however, no conclusions regarding the reliability of this study could be reached based on the lack of detailed information.
In accordance with column 2 of REACH (Regulation (EC) No 1907/2006) Annex VIII, the acute toxicity by dermal exposure study (required in section 8.5.3) does not need to be conducted as acute toxicity studies are available for the oral and inhalation routes of exposure.
Aluminium fluoride also is of low acute toxicity following inhalational exposure to the maximum practicable concentration.  The LC50 of AlF3 in rats was determined to be greater than 0.530 mg/L in air, the maximum practicable concentration, in an OECD guideline and GLP-compliant study (Test No. 403) (Coombs, 2002).  Clinical signs observed during the exposure period included exaggerated breathing in all test rats from 4 hours into exposure.  No other treatment-related effects were observed in all parameters examined.

Additional information

Acute Toxicity: Oral

The acute oral toxicity of AlF₃was assessed in Wistar (mol:WIST) rats in accordance with OECD Guidelines for the Testing of Chemicals No. 420 and in compliance with GLP (Bollen, 2001). The sighting study was performed in 1 female rat administered 500 mg AlF₃/kg body weight in 1% carboxymethyl cellulose (vehicle) by gavage. Aside from piloerection noted at 1 and 3 hours after treatment, no clinical signs of overt toxicity were observed in this animal, and therefore, a second female rat was administered 2000 mg AlF₃/kg body weight. No signs of overt toxicity were observed in this rat. Therefore, in the main study, 5 male and 5 female rats were orally administered 2000 mg/kg body weight of AlF₃in 1% carboxymethyl cellulose (vehicle) by gavage in a volume of 10 mL/kg body weight. Animals were observed over a 15-day period. No deaths occurred and animals displayed normal body weight gain during the study period. In addition, post-mortem examinations revealed no abnormalities. Based on the results of this study, the minimum lethal oral dose of AlF₃in rats was determined to be greater than 2000 mg/kg body weight.

In the IUCLID Dataset for aluminium fluoride as reported by the European Commission European Chemicals Bureau (2000), the minimum lethal oral dose of AlF₃in guinea pigs was determined to be equal to or greater than 600 mg/kg body weight. No conclusions regarding the reliability of this study could be reached based on the lack of detailed information.

Acute Toxicity: Inhalation

The acute inhalational toxicity of AlF₃was assessed in Sprague Dawley rats [Crl: CD® (SD) IGS BR] in accordance with OECD Guidelines for the Testing of Chemicals No. 403 and in compliance with GLP (Coombs, 2002). Male and female rats (5/sex/group) were exposed to AlF₃dust in nose-only chambers for a period of 4 hours at the maximum practicable concentration of the particulate aerosol. The time-weighted average chamber concentration was analytically determined to be 0.530 mg/L and was considered to be the maximum practicable concentration (the nominal concentration was 232.0 mg/L). No deaths occurred. Clinical signs observed during the exposure period included exaggerated breathing in all test rats from 4 hours into exposure and soiling of the fur with excreta in both test and control rats from 1 hour into exposure, the latter of which was considered to be associated with the method of restraint. Clinical signs observed during the observation period included exaggerated breathing in all test rats immediately following exposure, brown staining around the eyes in 1 male and 1 female test rat immediately following exposure, and soiling of the fur/skin with excreta in both test and control rats immediately following exposure. These signs were considered to be associated with the method of restraint. All test rats displayed normal appearance and behaviour from Day 1 of the observation period and no treatment-related effects on body weights were noted. Although small dark foci were noted on the lungs of 2 males in the test group, 1 male in the control group, and 1 female in the test group, no treatment-related findings at necropsy were observed. Lung weights also were unaffected by treatment. Furthermore, a visual appraisal of the water bottles indicated that the amount of water consumed by test animals was similar to that of the control animals. Based on the results of this study, the 4-hour LC50 for AlF₃in rats was determined to be greater than 0.530 mg/L in air, the maximum practicable concentration.

Justification for classification or non-classification

Based on the data presented, the minimum lethal oral dose is greater than 2000 mg/kg bw and as there were no unscheduled deaths in the acute inhalation toxicity study based on the maximum practicable 4-hour concentration of greater than 0.530 mg/L, the data are conclusive but not sufficient for classification.