Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Acute oral toxicity study according to the OECD TG 423 ( BASF SE 10A0788/11X368, 2012): 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:
2 000 mg/kg bw
Quality of whole database:
Guideline GLP 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 (OECD 423), 2000 mg/kg bw of the test item GSID 3056-1 (preparation in olive oil) were administered to two test groups of three fasted female Wistar rats each, by gavage. No mortality occurred, no clinical signs were observed, the mean body weight increased within the normal range throughout the study period and there were no macroscopic pathological findings in the animals sacrificed at the end of the observation period. The acute oral LD50 was > 2000 mg/kg bw.

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

Justification for classification or non-classification

based on the available acute oral toxicity study (OECD 423; LD50 > 2000 mg/kg bw; no mortality and no symptoms), no classification of the test item according to either the EU Directive 67/548/EEC or the CLP Regulation (EC) No. 1272/2008 is needed.