Registration Dossier
Registration Dossier
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EC number: 240-464-3 | CAS number: 16415-12-6
PBT assessment
Administrative data
PBT assessment: overall result
- Name:
- Hexadecyltrimethoxysilane
- Type of composition:
- boundary composition of the substance
- State / form:
- liquid
- Reference substance:
- Hexadecyltrimethoxysilane
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT Assessment is based on the criteria set out in the “Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.11: PBT Assessment” (ECHA, 2017).
Hexadecyl(trimethoxy)silane (CAS No. 16415-12-6) hydrolyses slowly in the environment (DT50 > 14 d at pH 4-10) forming hexadecylsilanetriol and methanol. Thus, the assessment is based on the parent substance.
Persistence assessment
One study is available, in which the biodegradation potential of the hexadecyl(trimethoxy)silane (CAS No. 16415-12-6) was tested according to OECD guidance 301F and GLP. The substance was readily biodegradable but failed the 10-day window (biodegradation of 65% and 81% after 28 and 60 d, respectively).
According to the Guidance on Information Requirements and Chemical Safety Assessment Chapter R.11: PBT/vPvB assessment (2017) if the criteria for ready biodegradability are fulfilled with the exception of the 10-day window, there is no reason to perform further biodegradation tests for the PBT/vPvB assessment. The substance does not fulfil the screening criteria for persistence (P or vP) and therefore it is concluded to be "not P/ vP".
Bioaccumulation assessment
The bioaccumulation assessment was not conducted since the substance is not persistent and according to ECHA Guidance on Information Requirements and Chemical Safety Assessment Chapter R.11: PBT/vPvB assessment (2017) further generation of information on bioaccumulation is only necessary, if the P criterion is fulfilled.
Toxicity assessment
Toxicity studies with aquatic organisms of three different trophic levels did not show any short-term toxicity effects up to the limit of water solubility. Long-term toxicity data are available for algae and aquatic invertebrates, which showed that the substance exhibits EC10/NOEC > 0.01 mg/L. Furthermore, the substance is not classified for specific target organ toxicity, carcinogenicity, mutagenicity and is not toxic for reproduction and development towards mammals. Therefore, the substance does not meet the screening criteria for toxicity and it is concluded to be "not T".
Reference
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