Registration Dossier

Administrative data

Description of key information

The test material is not acute toxic. 

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
3 100 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Additional information

This substance does not show any evidence of toxicity via the oral route of exposure in animals when tested in accordance with OECD Guideline 401. The rat oral LD50 is 3100 mg/kg in male rats. Sublethal effects of depression, diarrhea, and reduced food intake were observed. Necropsy observations included reduction of body fat, no specific organ toxicity is evident. 

 

This substance does not show any evidence of toxicity via the dermal route of exposure in animals when tested in accordance with OECD Guideline 402. The rat dermal LD50 is greater than 5000 mg/kg in male rabbits. Severe erythema and edema noted at 24 hours. Necrotic-appearing areas of lung tissue observed in five rabbits. Further histology of the lungs revealed confluent bronchopneumonia or chronic interstitial pneumonia.

 

Integrated testing strategies for acute toxicity state that determination of the most likely route of exposure needs to take into account not only how the substance is manufactured and handled, including engineering controls and risk management measures, but also the physicochemical properties of the substance. The test material has very low volatility. The vapour pressure has been determined to be 4.2x10-4Pa at 25oC, thus there is minimal potential for any inhalation of gases or vapors. ECHA guidance states that for the inhalation route no testing is required if the vapor pressure is very low (< 0.1 Pa at 20oC) (see ECHA Guidance R.7 as well as OECD GD 39). Therefore inhalative acute toxicity is of no relevance.

Justification for classification or non-classification

In accordance to Directive 67/548/EEC and EU CLP (Regulation (EC) No. 1272/2008), classification of this substance is not required for acute toxicity.