Registration Dossier

Administrative data

Description of key information

Available animal data indicate that ENB is an irritant to rabbit skin, and is very slightly irritating to the rabbit eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

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

Additional information

Occluded contact with 0.5 ml of undiluted ENB for 4 hrs produced mild to moderate erythema and edema on rabbit skin, which resolved by 7-14 days; necrosis was not seen. 0.1 ml of undiluted ENB instilled into the rabbit inferior conjunctival sac caused mild conjunctival hyperemia that resolved by 24-72 h post-instillation. With a volume of 0.01 ml, only slight conjunctival hyperemia developed within 1 h and resolved by 4h.

 


Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

SKIN: From the available data, the level of skin irritation as measured by erythema indicates classification as a skin irritant is warranted. Individual animal data is not available to enable a definitive classification against the criteria in regulation 1272/2008. However, it is quite conceivable that 2 or the 3 animals would have produced more severe reactions and therefore a similar classification (category 2 skin irritant) under this regulation would seem appropriate.

EYE: Available evidence in animal studies indicates that ENB is not an irritant by EU general classification criteria, therefore, no classification is proposed.