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Administrative data

Description of key information

In a subacute toxicity study (Thanikaivel V, 2008), Vegeflux Soy was administered to 5 Wistar rats/sex/dose by gavage at dose levels of 0, 150, 450 and 1000 mg/kg bw/day for 28 days. The test was performed according to OECD guideline 407 and GLP.
No effects were observed and NOEL of Vegeflux Soy is greater than 1000 mg/kg bw/day.

Key value for chemical safety assessment

Additional information

In a subacute toxicity study (Thanikaivel V, 2008), Vegeflux Soy was administered to 5 Wistar rats/sex/dose by gavage at dose levels of 0, 150, 450 and 1000 mg/kg bw/day for 28 days. The test was performed according to OECD guideline 407 and GLP. This subacute toxicity study in the rat is considered as acceptable.

 

There were no compound related effects in mortality, clinical signs, body weight, food consumption, haematology, clinical chemistry, organ weights, or gross and histological pathology.

Based on these results, the NOEL of Vegeflux Soy is greater than 1000 mg/kg bw/day.

Justification for classification or non-classification

Based on the classification criteria of Annex VI Directive 67/548/EEC or UN/EU GHS, and given the absence of signs of toxicity up to the highest dose of 1000 mg/kg bw/d administered in rats by gavage during 28 days, no classification for repeat-dose toxicity is warranted according to the criteria of Annex VI Directive 67/548/EEC or UN/EU GHS.