Registration Dossier

Administrative data

Description of key information

LD50 (oral,rat): > 2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
2 000 mg/kg bw
Quality of whole database:
GLP guideline study

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In an acute oral toxicity study performed according to the Acute Toxic Class method, 2000 mg/kg of the test item (R-)-3-Ammomium-1-hydroxybutyl (S)-mandelat (preparations in deionized water) were administered by gavage to two test groups of three fasted Wistar rats each (6 females).  Neither mortality nor clinical signs were observed in the first and second test group dosed with 2000 mg/kg bw. The body weights of the surviving animals increased within the normal range in the first observation week with one exception. One female animal of the second test group showed stagnation of body weight. During the second week, in four out of six animals (two in each test group) stagnation of body weight was observed, while the two remaining animals revealed a normal body weight increase.This effect is observed at times in the rat strain used, because in the required age range the female animals have already reached the phase of slow growth. There were no macroscopic pathological findings in all animals sacrificed at the end of the observation period. The acute oral LD50was calculated to be LD50, oral, rat > 2000 mg/kg bw. 

Justification for selection of acute toxicity – oral endpoint
only available study

Justification for classification or non-classification

No need for classification according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.