Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Additional information

Acute oral toxicity:

A GLP-compliant study was conducted in accordance with internationally accepted guideliunes (Bradshaw, 2012a). The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated in to be in the range of 300 - 2000 mg/kg bodyweight. On this basis, it is concluded that the following classification applies to copper iodide on the basis of acute oral toxicity:

  • Classification according to Directive 67/548/EEC: Harmful (Xn). R22, Harmful if swallowed.
  • Classification according to CLP/GHS: Acute Tox. 4, H302: Harmful if swallowed.

Acute inhalation toxicity:

A waiver has been provided for acute inhalation toxicity. On the basis of available information, it is proposed that copper iodide does not require classification for acute inhalation effects.

 

Acute dermal toxicity:

A GLP-compliant study was conducted in accordance with internationally accepted guidelines are available for acute dermal toxicity (Bradshaw, 2012b). The acute dermal median lethal dose (LD50) in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight. On this basis is is concluded that copper iodide is not classified on the basis of dermal toxicity.

Specific target organ toxicity – single exposure (STOT SE):

There was no evidence of any specific toxic effects on a target organ or tissue following single exposures to copper iodide.

Conclusion:

No classification as STOT-SE under regulation (EC) 1272/2008 is proposed.

 

Justification for classification or non-classification