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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

Persistence Assessment

N-[3-(trimethoxysilyl) propyl]butylamineis expected to hydrolyse rapidly (half-life approximately 4.0 h at 20-25°C and pH 7).The hydrolysis products are3-(N-butylamino)propylsilanetrioland methanol.Therefore, the substance is not persistent.

A reliable ready biodegradation study is available (Section 4.1.2.1.2), which indicates that no significant biodegradation is expected for the silanol hydrolysis product.Therefore, this hydrolysis product meets the criteria for persistence (P).

Methanol is readily biodegradable and therefore not persistent.

Therefore, the substance itself is not persistent, but the silanol hydrolysis product may meet the criteria for persistence (P).

Bioaccumulation Assessment

N-[3-(trimethoxysilyl) propyl]butylamineis expected to hydrolyse rapidly (half-life approximately 4.0 h at 20-25°C and pH 7).The hydrolysis products are3-(N-butylamino)propylsilanetrioland methanol.Therefore, the parent substance will not bioaccumulate.

The hydrolysis products3-(N-butylamino)propylsilanetrioland methanolhave low log Kowvalues (<3) and, therefore, are not likely to bioaccumulate.

Therefore, the substance does not meet the criteria for bioaccumulation; it is not B and not vB.

Toxicity Assessment

There are no long-term data available to assess the substance according to the definitive criteria for T for the environment. However the substance is not considered as T for the environment as the lowest measured EC50of > 100 mg/l for the read across substance do not meet the screening criteria for T for the environment (EC/LC50 <0.1 mg/l).

The substance is not classified for specific target organ toxicity, carcinogenicity, mutagenicity or reproductive and developmental toxicity in mammals (see Section 5.9). The criteria for “T” based on mammalian effects are therefore not met.