Registration Dossier

Administrative data

Description of key information

Vegeflux soy was tested for skin irritation (OECD 404, GLP) and eye irritation (OECD 405, GLP) in-vivo in rabbits:
- Vegeflux soy is not irritating to the skin in rabbit (scores 0)
- Vegeflux soy is not irritating to the eye in rabbit (scores 0)

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin irritation

In a primary dermal irritation study (Thanikaivel V, 2008), New Zealand White rabbits (3 males) were dermally exposed to 0.5 mL of undiluted Vegeflux soy for 4 hours to ca. 6 cm2 (occlusive test system). Animals then were observed for 3 days. Irritation was scored by the method of Draize.

 

No sign of irritation was observed during the 72-hour exposure period:

-        mean erythema score (24, 48, 72 h) = 0

-        mean edema score (24, 48, 72 h) = 0

 In this study, Vegeflux soy is not a dermal irritant. It is not classified according to EU criteria.

Eye irritation

In a primary eye irritation study (Thanikaivel V, 2008), 0.1 mL of undiluted Vegeflux Soy was instilled into the conjunctival sac of the left eye of three New Zealand White rabbits (female). The eyes were then observed at 1, 24, 48 and 72 hours after instillation. Irritation was scored by the method of Draize.

 

No effect was observed during the observation period; all the scores (cornea, iris, conjunctivae, chemosis) were equal to zero.

In this study, Vegeflux Soy is not an eye irritant in the rabbit. Vegeflux soy is not classified according to EU criteria.

Justification for classification or non-classification

Based on the classification criteria of Annex VI Directive 67/548/EEC or UN/EU GHS, the absence of dermal and ocular irritation in rabbits resulted in no classification of Vegeflux Soy for skin and eye irritation.