Registration Dossier

Administrative data

Description of key information

Only the acute toxicity (oral) was carried out. 
A test for the acute toxicity of the testing substance Actinol was carried out in three female and three male HanIbm: WIST (SPF) rats according to OECD Guideline for the Testing of Chemicals No. 423 and Directive 96/54/EEC, Annex B.1 tris. The testing animals received one single dose of Actionl by oral gavage. The test article was suspended in vehicle (bi-distilled water) at a concentration of 0.2 g/mL and administered at a volume of 10 mL/kg. The animals were examined for clinical signs five times during day 1 and once daily during days 2 -15. Mortality/viability were recorded together with clinical signs at the same time intervals. Bodyweights were recorded on day 1 prior to administration and on days 8 and 15. All animals were necropsied and examined macroscopically.
No death occurred during the study.
Several clinical signs like sedation, ventral position and ruffled fur were observed on test day 1 in males and females. All clinical signs were reversible on test day 5.
The bodyweight of the animals was within the range commonly recorded for this strain and age.
No macrocopic findings were observed at necropsy.
The median lethal dose of Actinol after a single oral dose to rats of both sexes, observed over a period of 14 days, could not be estimated as no death occurred.
LD50 rat: greater than 2000 mg/kg bodyweigth.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
2 000 mg/kg bw

Additional information

only one test avaialble, no further discussion needed

Justification for classification or non-classification