Registration Dossier
Registration Dossier
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EC number: 221-329-8 | CAS number: 3068-78-8
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
N-[3-(trimethoxysilyl)propylcyclohexylamine] (CAS 3068-78-8) hydrolyses rapidly in water (half-life = 4.1 min at 25 °C and pH 7) to N‑[3‑(trihydroxysilyl)propylcyclohexylamine] and methanol. The hydrolysis is 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).
Since no data on the biodegradation of the substance were available, good quality data from the analogues substance N-{[Diethoxy(methyl)silyl]methyl}cyclohexanamine (CAS 27445-54-1), were read across. After 28 d the percentage biodegradation of the source substance was 29% (based on BOD), when nitrification was taken into account. Therefore, the read across substance is considered as not rapidly biodegradable.
Based on the results of the analogue substance, N-[3-(trimethoxysilyl)propylcyclohexylamine] and its silanol hydrolysis product are considered not rapidly biodegradable. The other hydrolysis product methanol is known to be readily biodegradable (OECD, 2004).
Therefore, the substance is considered to meet the criteria for persistence (P and vP).
Bioaccumulation Assessment
The parent substance N-[3-(trimethoxysilyl)propylcyclohexylamine] (CAS 3068-78-8) degrades rapidly in water through hydrolysis (< 12 h at pH 4-7) resulting into N-[3-(trihydroxysilyl)propyl]cyclohexanamine 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 -0.1. The other hydrolysis product, methanol is also negligible with regard to bioaccumulation (OECD 2004).
Based on these information, N-[3-(trimethoxysilyl)propylcyclohexylamine] (CAS 3068-78-8) does not meet the criteria for bioaccumulation and is not B and not vB.
Toxicity Assessment
Studies in which the short term toxicity of the substance or the analogue substance N-{[Diethoxy(methyl)silyl]methyl}cyclohexanamine (CAS 27445-54-1), towards aquatic organisms of three different trophic levels are available. The lowest L(E)C50 value was 40.71 mg/L determined for algae. Long term data, available for algae resulted in EC10/NOEC > 0.01 mg/L. Furthermore, neither the substance nor its hydrolysis products are classified for specific target organ toxicity, carcinogenicity, mutagenicity and is not toxic for reproduction and development towards mammals. The criteria for “T” are therefore not met.
In conclusion N-[3-(trimethoxysilyl)propylcyclohexylamine] (CAS 3068-78-8) is not PBT/vPvB.
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