Registration Dossier

Diss Factsheets

Administrative data

Description of key information

No reliable study with magnesium sulphate is present. With potassium sulphate a reliable acute dermal toxicity study in rats (according to OECD 402) has been performed showing an LD50 > 2000 mg/kg bw. Reliable acute oral toxicity studies with rats according to OECD 425, one with potassium magnesium sulphate and another one with ammonium phosphate sulphate have been performed, and both showed LD50s>2000 mg/kg bw.  

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Value:
mg/m³ air

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

No reliable acute toxicity studies are available for magnesium sulphate. However, several second source publications show a high acute oral toxicity for magnesium sulphate. This is confirmed by reliable acute oral toxicity study performed in rats according to OECD 425 with potassium magnesium sulphate (LD50 > 2000 mg/kg bw). For acute dermal toxicity a reliable OECD, EC and EPA guideline study with potassium sulphate is available, showing an LD50>2000 mg/kg bw. In addition, reliable OECD guideline studies with ammonium sulphate (Yamanaka et all., 1990) also show acute oral and dermal toxicity values (LD50) of > 2000 mg/kg bw. A reliable acute oral toxicity study with ammonium phosphate sulphate also showed an LC50>2000 mg/kg bw. Therefore, acute toxicity studies with two possible routes of exposure are available and thus no acute inhalation study is required. However, a study with ammonium sulphate is available showing an LC50 of > 1200 mg/m3 (highest attainable concentration).

Justification for classification or non-classification

All data available show that magnesium sulphate does not have to be classified for acute toxicity according to Directive 67/548/EC and the CLP Directive.