Registration Dossier

Administrative data

Description of key information

Acute toxicity data by oral and dermal route indicate that Daltolac XR 159 is not harmful by all routes. The studies for the oral and dermal route were performed in rats comparable to the respective OECD guidelines 425 and 402, giving an oral and dermal LD50 of >2000 mg/kg . 

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
2 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
2 000 mg/kg bw

Additional information

Acute toxicity data for the oral and dermal routes were available. The acute oral toxicity study was performed according to GLP and OECD guideline 425, the up-and down procedure. Initially, one female Sprague Dawley rat was dosed at 175 mg/kg. No mortality was observed at 175 mg/kg and dosing continued in another female at 550 mg/kg. Dosing continued in three additional female at 2000 mg/kg as per protocol guidelines and then in one female at 5000 mg/kg. A total of 6 females were dosed. For doses of 175, 550 or 2000 mg/kg, no mortality was observed. The single animal dosed at 5000 mg/kg was found dead on Day 2.All animals appeared normal throughout the study at 175 and 550 mg/kg. Clinical signs of hunched posture, poor grooming, piloerection and wet and/or discoloured fur of the lower ventral area were observed in one of the three animals dosed at 2000 mg/kg. At 5000 mg/kg, abnormal gait and stance, decreased body tone, decreased activity, poor grooming and piloerection were observed on Day 1.No biologically significant effect was seen on body weights on Days 8 and 15. Furthermore, terminal necropsy revealed no visible lesions in any of the animals at 175, 550 or 2000 mg/kg. At 5000 mg/kg, necropsy revealed red-filled intestines in the animal found dead on Day 2. Ther fore, the LD 50 was set at > 2000 mg/kg bw (Calvert Laboratories, Inc., 2009a).

The dermal acute study was perfoemed according to GLP and OECD guideline 402. One group of ten Sprague-Dawley rats (five males and five females) were exposed one time to the test article dermally at a dose level of 2000 mg/kg. No abnormal clinical signs were observed during the study. No erythema or edema at the application sites was observed during the study. No mortality was observed during the study. No biologically significant effect was seen on body weight in the animals on Days 8 and 15. No visible lesions were observed in any of the animals at terminal necropsy. therefore, the dermal LD 50 was set at > 2000 mg/kg bw (Calvert Laboratories, Inc., 2009b)

Justification for classification or non-classification

According to EU Directive 67/548/EEC and  EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, classification and labelling is not needed for acute toxicity.