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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Description of key information

LD50 (oral) ca 4788 mg/kg bw active ingredient

Key value for chemical safety assessment

Additional information

The potential of the substance for acute toxicity following oral administration was tested in male and female rats of the CFY strain. 5 animals per sex per dose were tested at doses of 4000, 6400, 10000 and 16000 mg/kg bw and observed for 14 days.

Sign of reaction to treatment observed shortly after dosing, included lethargy, pilo-erection, abnormal body carriage (hunched posture), abnormal gait (waddling), ptosis and diarrhoea. These signs were accompanied by increased salivation and decreased respiratory rate amongst rats treated at 6.4 g/kg and above and by diuresis amongst rats at 10 to 16 g/kg.

Yellow colouration of the urine and faeces was noted for rats trated at 16 g/kg.

Death occured among rats treated at 4.0, 10 or 16 g/kg within 3 to 29 hours of dosing. Autopsy revealed congestion and haemorrhage of the lungs and pallor of the liver, spleen and kidneys.

 

Based on the active ingredient content, namely 4788 mg/kg bw, the test substance is not classified as acutely toxic by oral exposure route.

Justification for classification or non-classification

The CLP Regulation (EC 1272/2008), Annex I, Part 3, Table 3.1.1 gives the following criteria for acute oral toxicity: "Category 4: 300 < ATE ≤ 2 000," where ATE is acute toxicity estimates in mg/kg bodyweight.

LD50 of the test substance is considered > 4.000 mg/kg bw, which is outside the above criteria.

Therefore, the test substance is not acutely toxic by the oral exposure route.