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Administrative data

Description of key information

Vegeflux soy was tested for acute oral toxicity (OECD 423, GLP) and acute dermal toxicity (OECD 402, GLP) in the rats:
- Oral LD50 Females > 2000 mg/kg bw (no mortality)
- Dermal LD50 (Males & Females) > 2000 mg/kg bw (limit test) (no mortality)

Key value for chemical safety assessment

Additional information

Acute toxicity: oral

In an acute oral toxicity study (Venkatasubramani R, 2008), groups of 8-12 weeks old Wistar rats (2 x 3 females per group) were given a single oral dose of Vegeflux Soy in 2% DMSO at doses of 300 and 2000 mg/kg bw and observed for 14 days. The test was performed according to OECD test guideline 423 and GLP.

 

Oral LD50 Females > 2000 mg/kg bw

No mortality, clinical signs, body weight changes or gross pathology changes were observed during the observation period.

 

Vegeflux Soy is of low toxicity based on the LD50 in females by gavage. Vegeflux soy is not classified as dangerous according to EU criteria, by oral intake.

Acute toxicity: dermal

In an acute dermal toxicity study (Venkatasubramani R, 2008), groups of Wistar rats (5/sex) were dermally exposed to Vegeflux soy undiluted for 24 hours to 10% of body surface area at doses of 2000 mg/kg bw. Animals then were observed for 14 days. The test was performed according to OECD guideline 402 and GLP.

 

Dermal LD50 (Males & Females) > 2000 mg/kg bw (limit test)

No mortality, clinical signs, body weight changes or gross pathology changes were observed during the observation period.

 

Vegeflux Soy is of low toxicity based on the LD50 in males and females by dermal application. Vegeflux soy is not classified as dangerous according to EU criteria, by dermal application.

Justification for classification or non-classification

Vegeflux Soy induces no mortality in the rat following a single exposure by oral and dermal route up to 2000 mg/kg bw and thus should not to be classified for acute toxicity via the oral and dermal route as defined by the criteria of Annex VI Directive 67/548/EEC or UN/EU GHS classification criteria.