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Description of key information

In a GLP-compliant in vitro skin corrosion/irritation study performed according to test guidelines, the substance was considered to be not a skin irritant.
In accordance with section 1 of REACh (Regulation (EC) No 1907/2006) Annex XI, the in vivo skin irritation study (required in Annex VIII section 8.1.1) is not scientifically necessary as the in vitro EpiSkin study is valid for the classification of substances for skin irritancy according to CLP criteria; further testing on vertebrate animals for skin irritation shall be omitted.
In a GLP-compliant in vitro Bovine Corneal Opacity and Permeability (BCOP) test performed according to test guidelines, the substance was considered to be not ocular corrosive. BCOP is a screening test and it is not conclusive about eye irritation potential.

Key value for chemical safety assessment

Skin irritation / corrosion

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

Additional information

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

The substance is not classified skin irritant based on conclusive experimental results.

 

The substance is screened out from severe eye irritant or corrosive to eye classification based on conclusive experimental results. Available in-vitro results are not enough to be conclusive to eye irritation potential.

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