Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Description of key information
The test substance was predicted not to be an irritant to either skin or eyes, on the basis of results from relevant in-vitro tests.
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
An EPISKIN Skin irritation test was conducted by Huntingdon Life Sciences, UK, to assess the potential of the test substance to cause skin irritation, by means of an in-vitro test. The EPISKIN test has been accepted as a replacement to the in vivo test (Draize Skin Irritation Test), by the European Centre for the Validation of Alternative Methods (ECVAM), and a draft proposal for a new OECD test guideline was followed. The study was conducted in accordance with GLP.
It was concluded that the test substance was predicted as a non irritant to the skin.
An in-vitro eye irritation / corrosion test was conducted by Huntingdon Life Sciences, UK, to assess the potential for eye irritation of the test substance. The study was conducted according to OECD test guideline 437, and in compliance with GLP.
The corneas from freshly excised Bovine eyes were exposed to a 20% (w/w) solution of the test material in saline solution (sodium chloride 0.9% (w/v) solution) for four hours prior to washing, recording of the opacity, then determination of the permeability.
The test substance elicited an In Vitro Irritancy Score of 0.7 ± 2.4 and was predicted to be a non corrosive / non severe eye irritant.
Justification for classification or non-classification
The irritant properties to skin and eyes of the substance were assessed using relevant in-vitro tests. The tests indicated that the test substance would not be expected to cause irritation either to skin or eyes. The test substance does not require classification according to EC Directive 67/548/EEC on the basis of these results.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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