Registration Dossier
Registration Dossier
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EC number: 500-241-6 | CAS number: 69011-36-5 1 - 2.5 moles ethoxylated
PBT assessment
Administrative data
PBT assessment: overall result
- 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).
Persistence
The substance Isotridecanol, ethoxylated, < 2.5 EO (CAS 69011-36-5) is considered to be readily biodegradable (75% after 28 day, OECD 301B; read-across). Based on the available results Isotridecanol, ethoxylated, < 2.5 EO does not meet the screening criterion for persistence and is not considered to be P or vP.
Bioaccumulation
The bioconcentration factors of alcohol ethoxylates in the aqueous phase are generally < 2000 L/kg, and for some non-ionic surfactants can be quantitatively related to the length of the hydrophobic and hydrophilic components. There is also evidence that overall molecular size may place constraints on biological uptake. The various studies cited raise no concerns with respect to long-term retention of accumulated surfactant material in tissue, and indeed, they present considerable evidence that alcohol ethoxylates are rapidly eliminated and metabolised. Although the fate of metabolites of AE has not been thoroughly studied, rapid biodegradation of alcohol ethoxylates in the aquatic environment is considered a mitigating aspect, since the rate of biodegradation of alcohol ethoxylates are significantly faster than the uptake rates of bioaccumulation. Based on the available data Isotridecanol, ethoxylated, < 2.5 EO is not considered to be B or vB.
Toxicity
For Isotridecanol, ethoxylated, < 2.5 EO the available acute effect concentrations are > 0.1 mg/L (fish, aquatic invertebrates, algae) and the chronic effect concentration (fish, daphnia, algae) is ≥ 0.01 mg/L. Moreover, the substance is not classified according to the consolidated version of Regulation (EC) No 1272/2008 as carcinogen, germ cell mutagenic or toxic for reproductionaccording to Regulation (EC) No 1272/2008. In addition, the substance shows no specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation (EC) No 1272/2008. Thus, the test substance is not considered to meet the T criterion.
In conclusion the substance is not PBT/vPvB.
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