Registration Dossier

Administrative data

Description of key information

Oral: An analogue substance suitable for read across does not show evidence of toxicity via the oral route of exposure in animals when tested in accordance with OECD Guideline 401.  The oral LD50 is 3400 mg/kg in male rats. At doses below 2900 mg/kg, no toxicity was observed in male or female animals. Therefore, for calculation of the Acute Oral DNEL, the value 2900 mg/kg was selected.
Dermal: This substance shows minimal evidence of toxicity via the dermal route of exposure in animals when tested in accordance with OECD Guideline 402. The dermal LD50 is greater than 5000 mg/kg in male rabbits. Therefore, for calculation of the Acute Dermal DNEL, the value 5000 mg/kg was selected.
Inhalation: Substance has a very low volatility (< 0.1 Pa at 20oC) therefore testing is not necessary. Since no Inhalation data are available for this substance, the value used to calculate the Acute Oral DNEL is also used to calculate the Acute Inhalation DNEL.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 900 mg/kg bw

Acute toxicity: via dermal route

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

Additional information

An analogue substance suitable for read across does not show evidence of toxicity via the oral route of exposure in animals when tested in accordance with OECD Guideline 401. The oral LD50 is 3400 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. No toxicity was observed at doses below 2900 mg/kg.

 

This substance shows minimal evidence of toxicity via the dermal route of exposure in animals when tested in accordance with OECD Guideline 402. The 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 was too low to measure and an analogue substance (EC#272 -238 -5) was 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.