Registration Dossier
Registration Dossier
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EC number: 240-465-9 | CAS number: 16415-13-7
PBT assessment
Administrative data
PBT assessment: overall result
- Name:
- RECONSILE Triethoxyhexadecylsilane 16415-13-7
- Type of composition:
- boundary composition of the substance
- State / form:
- liquid
- Reference substance:
- RECONSILE Triethoxyhexadecylsilane 16415-13-7
- PBT status:
- the substance is not PBT / vPvB
- Justification:
Persistence Assessment
Triethoxy(hexadecyl)silane (CAS 16415-13-7) hydrolyses slowly in the environment (half-life = 58.4 h at 20-25 °C and pH 7) and hexadecylsilanetriol and ethanol are formed. Even though the hydrolysis is slow it is also expected to occur during the duration of 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 formation of stable degradation products with PBT/vPvB properties should be considered for PBT assessment (ECHA, 2017).
Since no data on the biodegradation of triethoxy(hexadecyl)silane (CAS 16415-13-7) were available, good quality data from the analogue substance, chloro(dimethyl)octadecylsilane (CAS 18643-08-8), were read across. The percentage biodegradation of chloro(dimethyl)octadecylsilane was found to be 57% after 28 d and 65% after 60 d. Therefore, the read across substance is considered as inherently biodegradable. Based on the results of the analogue substance, triethoxy(hexadecyl)silane is assumed to be inherently biodegradable as well. The other hydrolysis product ethanol is readily biodegradable (OECD, 2004). Therefore, triethoxy(hexadecyl)silane is not considered to meet the criteria for persistence (P and vP).
Bioaccumulation Assessment
Since triethoxy(hexadecyl)silane (CAS 16415-13-7) does not meet the P/vP criteria a bioaccumulation assessment was not performed in accordance with ECHA Guidance R.11 (ECHA, 2017).
Toxicity Assessment
Studies with aquatic organisms of three different trophic levels did not show any short term toxicity effects up to the highest tested concentration of 100 mg test item/L. Long-term toxicity data available for algae, showed that the substance and its hydrolysis product exhibit EC10/NOEC > 0.01 mg/L and are therefore not considered as T for the environment. 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” based on mammalian effects are therefore not met.
In conclusion the substance is not PBT/vPvB.
Reference
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