Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Additional information

This multi-constituent substance was tested for acute oral, dermal, and inhalation toxicity. The aqueous dispersion was tested (approx. 20% solids and 80% water) was administered directly without correction for active ingredient in an acute oral up/down study and acute dermal study in rats. In both the acute oral and dermal studies, the material was not toxic and the LD50 was determined to be >5000 mg aqueous dispersion/kg or >1000 mg a.i /kg of the multi-constituent substance. In another acute oral up/down LD50 study, female mice were administered a similar test substance formulation and the LD50 was determined to be >5000 mg aqueous dispersion/kg. A correction for active solids was made and an additional dose was administered with no mortality resulting from >2000 mg a.i./kg. Due to animal welfare considerations, no further oral administrations at higher corrections were made and the oral LD50 can be estimated to be >2000 mg a.i./kg. The Approximate Lethal Concentration (ALC) or the threshold for lethality was the resulting endpoint from this study and was determined to be 86 mg a.i./m³ (respirable particulate), indicating the material may be toxic with inhalation of respirable particulate, the vapour is not expected to be toxic. A full LC50 evaluation has not been conducted on this material or any similar substance. However, an acute toxicity estimation (ATE) can be used to determine classification, therefore, the ATE is 0.05 mg/L and this value will be used to make an acute inhalation classification.

Justification for classification or non-classification

This multi-constituent substance was tested for acute oral, dermal, and inhalation toxicity. The aqueous dispersion was tested (approx. 20% solids and 80% water) was administered directly without correction for active ingredient in an acute oral up/down study and acute dermal study in rats. In both the acute oral and dermal studies, the material was not toxic and the LD50 was determined to be >5000 mg aqueous dispersion/kg or >1000 mg a.i /kg of the multi-constituent substance. In another acute oral up/down LD50 study, female mice were administered a similar test substance formulation and the LD50 was determined to be >5000 mg aqueous dispersion/kg. A correction for active solids was made and an additional dose was administered with no mortality resulting from >2000 mg a.i./kg. Due to animal welfare considerations, no further oral administrations at higher corrections were made and the oral LD50 can be estimated to be >2000 mg a.i./kg. The Approximate Lethal Concentration (ALC) or the threshold for lethality was the resulting endpoint from this study and was determined to be 86 mg a.i./m³ (respirable particulate), indicating the material may be toxic with inhalation of respirable particulate, the vapour is not expected to be toxic. A full LC50 evaluation has not been conducted on this material or any similar substance. However, an acute toxicity estimation (ATE) can be used to determine classification, therefore, the ATE is 0.05 mg/L and this value will be used to make an acute inhalation classification.