Registration Dossier
Registration Dossier
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EC number: 811-616-1 | CAS number: 1563063-07-9
Endpoint summary
Administrative data
Description of key information
Skin corrosion (OECD 431): non-corrosive (worst case assumption: irritating)
Eye irritation (OECD 492): eye hazard potential
Eye irritation (OECD 437): not irritating
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin
The skin corrosion potential of the test substance was determined in an in vitro skin corrosion test using a human skin model according to OECD Guideline 431 and in compliance with GLP (2016). In this study the test substance did not possess corrosive properties towards human-derived epidermal keratinocytes.
As the skin irritation potential of the test substance was not further investigated, based on a worst case assumption, the test substance is classified as irritating to skin.
Eye
The eye irritation potential of the test substance was determined in an in vitro eye irritation test using a human cornea model according to OECD Guideline 492 and in compliance with GLP (2016). In this study the test substance possessed irritating properties towards human-derived epidermal keratinocytes. Additional testing is required to establish a definitive classification.
To exclude corrosive properties towards the eyes, a bovine corneal opacity and permeability (BCOP) test according to OECD Guideline 437 and in compliance with GLP was conducted (2016). Application of the test substance to bovine corneae resulted in a calculated mean IVIS of 0.85. Based on this result, the test substance does not have to be classified according to OECD Guideline 437.
However, since the EpiOcular test revealed eye irritating properties, the test substance is classified as irritating to the eye (Eye Irrit.2; H319) in a worst case assumption.
Justification for classification or non-classification
The available data on skin irritation meet the criteria for classification as Skin Irrit. Cat. 2 (H315) according to Regulation (EC) No 1272/2008.
The available data on eye irritation meet the criteria for classification as Eye Irrit. Cat. 2 (H319) according to Regulation (EC) No 1272/2008.
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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