Registration Dossier
Registration Dossier
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EC number: 931-082-4 | CAS number: -
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
Persistence assessment
Ready biodegradability may be used as a screening criterion of P and vP (REACH Guidance on information requirements and chemical safety assessment Chapter R.11: PBT Assessment, Table R.11-2). Ready biodegradability of
NExBTL renewable diesel, which is a UVCB substance of similar composition to the substance (- see analogue approach justification document), was determined in a GLP compliant laboratory according to OECD Guideline 301B
(Ready biodegradability; CO2 Evolution test). As a result, the test material was found readily biodegradable. Therefore, it can be concluded that is also readily biodegradable.
Value used for CSA: not P and not vP
Bioaccumulation Assessment
BCFWIN v2.17 software developed by US-EPA (2000) was used for modelling of bioaccumulation of the substance. The BCFs of individual n-alkane and i-alkane congeners composing > 99.9 % of all congeners present in the substance were determined. A weighed average was used for B and vB assessment. BCF of the substance is 356.
Value used for CSA: not B and not vB
Toxicity Assessment
Chronic NOEC was used for assessing T criteriaof the substance. Chronic toxicity of NExBTL renewable diesel, which is a UVCB substance of similar composition to the substance, was determined in a GLP compliant laboratory according to OECD Guideline 211 (Daphnia magna Reproduction test). The long-term NOEC was 1 mg/l (WAF).
With regard to the specific health properties relevant to this PBT/vPvB assessment it is concluded that the substance is not carcinogenic, mutagenic or reprotoxic nor does it possess hazards of equivalent concern.
Value used for CSA: not T
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