Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

Key value for chemical safety assessment

Absorption rate - oral (%):
50
Absorption rate - dermal (%):
50
Absorption rate - inhalation (%):
100

Additional information

No data on ADME, dermal absorption and toxicokinetics of the test material are available.

The substance is corrosive. No useful conclusions can be determined from the acute oral studies, other than lethality appears to be the result of portal-of-entry corrosive effects rather than intrinsic acute toxicity.

Animals repeatedly treated by the oral route showed signs of systemic toxicity. In a subchronic dietary 90-day, dosages up to 7500 ppm in the diet were well tolerated, without any signs of irritation to the gut, and with the NOAEL based on effects on liver. Some clinical signs likely related to portal-of-entry corrosive effects were observed following oral gavage at high doses (300 and 1000 mg/kg/day) in the teratogenicity study in rats, and supported by necropsy findings in the stomach. In

a repeated 28-day inhalation study, local effects on the lungs precluded setting a NOAEL, but because mortalities and effects on body weight occurred only at the highest concentration tested, it was possible to set the mid concentration as the NOAEL for systemic effects.

In the absence of quantitative data, and in line with ECHA guidance, oral and dermal absorption are set at 50% and inhalation exposure is considered to be 100% for risk assessment purposes.