Registration Dossier
Registration Dossier
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EC number: 615-247-5 | CAS number: 71060-57-6
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 substances of the Alcohol Ethoxylates (AE) category are readily biodegradable. All available screening studies, investigating the ready biodegradability of the substances, demonstrated degradation rates > 60% after 28 days. The substances of the Alcohol Ethoxylates (AE) category are expected to be ultimately degraded in the environment and persistence of the substances is unlikely. Based on the available results the substances of the Alcohol Ethoxylates (AE) category do 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 below the level of concern, and for some nonionic 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 to be a mitigating aspect, since the rate of biodegradation of alcohol ethoxylates are significantly faster than the uptake rates of bioaccumulation. Based on the available results the substances of the Alcohol Ethoxylates (AE) category are not considered to be B or vB.
Toxicity
No long-term effects below the trigger value of 0.01 mg/L (EC10 or NOEC) occurred. 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 reproduction. Thus, the criteria set out in Annex XIII of Regulation (EC) No. 1907/2006 are not met and the test substance is not considered to meet the T criterion.
The assessment is based on the data currently available. New studies, based on the category review and the final decisions issued for some of the category substances, which are also relevant for this assessment, are currently being conducted. The finalised studies will be incorporated into the dossiers and the aquatic toxicity will be re-assessed in the updated dossiers by the 20th of June 2022.
In conclusion the substance is not PBT/vPvB.
- Likely routes of exposure:
The substance does not fulfill the PBT and vPvB criteria; no emission characterisation needs to be performed.
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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