Registration Dossier

Administrative data

Description of key information

The substance was not irritating to skin and eyes in rabbits.

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

An acute dermal irritation GLP study according to OECD guideline 404 was conducted in 3 male New Zealand White rabbits in order to evaluate the irritation and corrosion effects of AC-6000 on the skin (NOTOX B.V., 2007). In this study 0.5 mL of the test substance was applied to the clipped skin of rabbits for 4 hours using a semi-occlusive dressing. Skin reactions were assessed 1, 24, 48 and 72 hours after exposure. No skin irritation was caused by 4 hours exposure to AC-6000. The mean (24, 48 and 72 hours) scores for erythema and edema were both 0. Based on these results AC-6000 can be regarded as not irritating to skin.

 

Eye irritation

An acute eye irritation GLP study according to OECD guideline 405 was conducted in three male New Zealand White rabbits in order to evaluate the irritation and corrosion effects of AC-6000 on the eyes (NOTOX B.V., 2007). In this study 0.1 mL of the test substance was applied to the left eye of the rabbits. No washing was performed. Observations were made 1, 24, 48 and 72 hours after instillation. No irritation of the ocular tissues was noted after instillation of AC-6000. The mean (24, 48 and 72 hours) cornea, iris, conjunctivae and chemosis scores were all 0. Based on these results AC-6000 can be regarded as not irritating to the eyes.

Justification for classification or non-classification

Based on the results of the skin and eye irritation studies, classification according to EU Directive 67/584/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 is not needed.