Registration Dossier
Registration Dossier
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EC number: 259-715-3 | CAS number: 55589-62-3
Endpoint summary
Administrative data
Description of key information
The skin and eye irritation studies with rabbits indicate that Acesulfame potassium is not irritating to the skin or the eyes.
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)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
In a primary skin irritation study, 3 young adult white rabbits were dermally exposed to 500 mg of Acesulfame potassium moistened with physiological saline for 4 hours under semi-occlusive condition. The animals were observed for up to 3 days. Irritation was scored according to the scoring scheme of Draize as recommended procedure by OECD guideline 404.
Erythema and edema were not noted at any reading time point.
Eye irritation:
In a primary eye irritation study, 0.1 ml of the unchanged Acesulfame potassium was instilled into the conjunctival sac of the left eye of three young adult New Zealand White rabbits. The right eyes served as controls. The animals were observed for up to 14 days and the readings were performed at 1, 24, 48, 72 hours, 7 and 14 days. Irritation was scored according to the scoring scheme of Draize as recommended procedure by OECD guideline 405.
The application led primarily initially and transiently to signs of conjunctival irritation, discharge and affected iris. The cornea was not affected at any time point. All signs were completely reversible by the end of the observation period on day 14 at the latest. At all relevant time points, the mean scores were below those relevant for classification.
Justification for classification or non-classification
The skin and eye irritation studies with rabbits indicate that Acesulfame potassium is not irritating to the skin or the eyes.
The study results triggers the following classification/labelling:
EU Directive 1999/45/EC (as amended): none
Regulation (EC) No 1272/2008 (CLP): none
GHS (rev. 4) 2011: unclassified
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