Magnesium fluoride

Endpoint summary

Description of key information

Oral exposure

There is one good quality guideline compliant acute toxicity study via oral route (OECD 423 - Acute Toxic Class Method) conducted for magnesium fluoride (Hózová, R. 2016). The purpose of the study was to evaluate the potential toxic effect of the test item Magnesium Fluoride after single oral administration to rats. A limit dose of 2000 mg/kg body weight was used as starting dose.In this study, the LD50 value of the substance in the female rats was estimated to be greater than 2000 mg/kg of body weight.

In the study of Hózová, R. (2016) three female rats were gavaged with undiluted test substance at a dose level of 2000 mg/kg bw. No mortalities were observed during the test. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy. The post exposure period was 14 days. All animals showed expected gains in bodyweight. No abnormalities were noted at necropsy. The acute median lethal dose (LD50) of the test item in female Wistar rat was estimated to be greater than 2000 mg/kg bodyweight.

As a conclusion, the results of the key study did not indicate this substance to be classified for acute toxicity via oral route.

Inhalation exposure

In accordance with column 2 of REACH Annex VIII, testing by the inhalation route is not needed if exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and there is no possibility of exposure to aerosols, particles or droplets of an inhalable size. The vapour pressure of magnesium fluoride is impossible to measure due to the extremely low value.

 

In addition, PPEs are in use during the use of the substance so there is no risk of exposure to magnesium fluoride via inhalation route. The PPEs and risk management measures are demonstrated in the CSR section 9 and 10. Due to these facts human exposure via inhalation route is not considered likely.

 

Dermal exposure

In accordance with column 2 of REACH Annex VIII the acute toxicity by dermal route is not needed if skin contact in production and use is not likely. The PPEs are worn to protect skin during the use of the substance. The risks for acute systemic effects via dermal route are adequately controlled with the risk management measures presented for long-term systemic effects (see CSR sections 9&10). Based on the in vitro Skin irritation study result (OECD 439) this substance is not irritating to the skin. Due to these facts human exposure via dermal route is not considered likely.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The available data for Magnesium Fluoride indicate no potential for acute toxicity. Based on the oral LD50 value the substance no classification is warranted for acute toxicity according to CLP Regulation 1272/2008.