Registration Dossier
Registration Dossier
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EC number: 280-084-5 | CAS number: 82985-35-1
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT Assessment for the substance is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment”.
Persistence Assessment
Bis(trimethoxysilylpropyl)amine (CAS 82985-35-1) hydrolyses rapidly in water (half-life = 6.9 h at neutral pH and room temperature) to bis(trihydroxysilylpropyl)amine and methanol. The hydrolysis is therefore expected to occur during a standard biodegradation test. According to the Guidance on Information Requirements and Chemical Safety Assessment Chapter R.11: PBT/vPvB assessment, hydrolysis is considered as primary degradation and the stable degradation products formed, should be considered for PBT assessment (ECHA, 2017).
A guideline study showed that the percentage biodegradation of the substance within 28 d was 48% based on DOC removal and is clearly coupled to the biodegradation of the non silanol hydrolysis product methanol. The silanol hydrolysis product was not biodegradable. Therefore, the parent substance and its silanol hydrolysis product are not considered rapidly biodegradable.
On this basis, the substance is considered to meet the criteria for persistence (P and vP).
Bioaccumulation Assessment
The parent substance bis(trimethoxysilylpropyl)amine (CAS 82985-35-1) degrades rapidly in water via hydrolysis resulting into bis(trihydroxysilylpropyl)amine and methanol. Therefore the hydrolysis products are more relevant concerning bioaccumulation potential than the parent substance. The silanol hydrolysis product bears a very low log Kow value of -4. The other hydrolysis product, methanol is also negligible with regard to bioaccumulation (OECD 2004).
Based on these information, bis(trimethoxysilylpropyl)amine (CAS 82985-35-1) does not meet the criteria for bioaccumulation and is not B and not vB.
Toxicity Assessment
Studies are available, in which the short term toxicity of bis(trimethoxysilylpropyl)amine (CAS 82985-35-1) towards aquatic organisms of three different trophic levels has been assessed. The EC10/NOEC value was determined for algae and was > 0.01 mg/L. Furthermore, neither the substance nor its hydrolysis products are classified for specific target organ toxicity, carcinogenicity, mutagenicity and are not toxic for reproduction and development towards mammals. The criteria for “T” are therefore not met.
In conclusion bis(trimethoxysilylpropyl)amine (CAS 82985-35-1) is not PBT/vPvB.
Reference:
OECD (2004): SIDS Initial Assessment Report for SIAM 19, Berlin, Germany, 18-20 October 2004, Methanol, CAS 67-56-1.
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