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EC number: 250-437-8 | CAS number: 31024-56-3
Biodegradation in water and sediment: simulation tests
Administrative data
Link to relevant study record(s)
- Endpoint:
- biodegradation in water: sediment simulation testing
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Transformation products:
- yes
- Remarks:
- Degradation is principally expected via abiotic transformation (aqueous). The transformation products expected are those identified in IUCLID section 1.10 "transformation of the registered substance", the environmental hazard assessment is based on those.
- No.:
- #1
- No.:
- #2
- Endpoint:
- biodegradation in water: simulation testing on ultimate degradation in surface water
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Transformation products:
- yes
- Remarks:
- Degradation is principally expected via abiotic transformation (aqueous). The transformation products expected are those identified in IUCLID section 1.10 "transformation of the registered substance", the environmental hazard assessment is based on those.
- No.:
- #1
- No.:
- #2
Referenceopen allclose all
Description of key information
The simulation tests on ultimate degradation in surface water/sediment and identification of degradation products do not need to be conducted as:
- in accordance with Column 2 of REACH Annex IX, the chemical safety assessment according to Annex I indicates that this is not necessary,
and
- in accordance with Section 3 of REACH Annex XI, exposure of the aquatic/sediment compartment is not significant.
Key value for chemical safety assessment
Additional information
The simulation tests on ultimate degradation in surface water and sediment as well as the identification of degradation products do not need to be conducted as:
- in accordance with Column 2 of REACH Annex IX, the chemical safety assessment according to Annex I indicates that this is not necessary,
and
- in accordance with Section 3 of REACH Annex XI, exposure of the aquatic/sediment compartment is not significant.
Many organosilicon compounds hydrolyse rapidly to a silanol and a by-product such as ethanol, methanol or HCl. For most organosilicon compounds, little or no degradation is observed in ready biodegradation studies once degradation of any readily biodegradable hydrolysis by-product is accounted for. This is supported by a small number of simulation studies that show limited biodegradation. Therefore, most organosilicon compounds either meet the criteria for persistence or produce transformation products that may meet the criteria for persistence based on currently available data. The available evidence regarding biodegradation and persistence of organosilicon compounds is summarised in an attached document in Section 13 (PFA 2021).
The registered substance is ‘not readily biodegradable’ and is expected to hydrolyse rapidly (DT50 = 4.0 h at 20-25 °C and pH 7) to the silanol hydrolysis product 3-(N-butylamino)propylsilanetriol and the alcohol hydrolysis product methanol. The exposure assessment and risk characterisation are carried out for the silanol hydrolysis product on the basis that it is not biodegradable. Risk characterisation ratios are below 1. The non-silanol hydrolysis product, methanol, is readily biodegradable (OECD SIDS, 2004). Therefore, further testing for biodegradation would not affect the outcome of the environmental risk characterisation.
Since degradation of the registration substance is expected to be principally via abiotic transformation under the aqueous conditions of a degradation simulation study, the transformation products expected in the environment are those identified as the hydrolysis products in Section 1.10 of the IUCLID.
The silanol hydrolysis product is considered to be not B based on the low log Kow of -0.9 (QSAR). Therefore, further testing for persistence would not affect the overall outcome of the PBT/vPvB assessment.
The chemical safety assessment does not indicate any need to investigate further the degradation of the substance, or either of its hydrolysis products, at the present time.
References:
OECD, 2004: SIDS Initial Assessment Report for Methanol, SIAM 19, Berlin, Germany, 19-22 October 2004, Methanol, CAS 67-56-1
PFA (2021): Background to persistence assessment of organosilicon compounds, Reference: PFA.923.001.001, February 2021.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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