Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

Reference
Name:
Calcium bis(4-{[(2S,4R)-1-(biphenyl-4-yl)-5-ethoxy-4-methyl-5-oxopentan-2-yl]amino}-4-oxobutanoate)
Type of composition:
legal entity composition of the substance
State / form:
solid: particulate/powder
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

The substance is non-sensitizing, non-mutagenic in vitro, non- irritating, and is non-toxic orally in an acute study.

It shows no acute and/or chronic aquatic toxicity. Phisical chaemical properties of the substance indicate that it is not bioaacumulative (logPow is -0.72).

Likely routes of exposure:

Used as an industrial intermediate, not used outside production facility.

The substance is received onto the site in kegs. It is dischargerd from kegs into flexible intermediate bulk containers (FIBCs) using a laminar flow charging booth (open charging). It is then charged from FIBCs to the reaction vessel (closed charging).

The substance is 100 % converted in chemical reaction. No remains in waste are expected.

Packaging (Kegs / liners) AHU377 <5% waste packaging is recycled

 Packaging (Bigbag / liner) AHU377 <5% big bags are incinerated

Process Safety training of all personnel handling the substance. Personal protective clothing is specified: Tyvek classic suit, air hood or air fed respirator and Camatril gloves taped to the suit at the wrist.