Registration Dossier
Registration Dossier
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EC number: 939-266-6 | CAS number: 1179883-13-6
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT Assessment for D-Glucose, reaction products with alcohols C16-18 (even numbered) (excess) is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2008).
Persistence
Screening criteria:
D-Glucose, reaction products with alcohols C16-18 (even numbered) (excess) is readily biodegradable in a study according to OECD 301B (66% (CO2 evolution) after 28 d). Thus, the substance does not meet the screening criterion for persistence and it is not considered to be persistent (P) or very persistent (vP).
Bioaccumulation
D-Glucose, reaction products with alcohols C16-18 (even numbered) (excess) has a log Kow of 7.72 (worst-case QSAR, KOWWIN).
APGs are predicted to be bioavailable via the oral route. They will undergo stepwise hydrolysis into glucose and fatty alcohol, which is further oxidised to the corresponding fatty acid and incorporated in the β-oxidation cycle and oxidative phosphorylation. Excretion is assumed to occur mainly via renal elimination. Tissue accumulation can be excluded.
Generally, bioconcentration factors of APGs in the aqueous phase are expected to be below the level of concern. This is also supported by the low BCF values that were calculated for representative constituents of the test substance using the BCFBAF model (v3.01, Episuite 4.11).
Also, overall molecular size may place constraints on biological uptake. Long-term retention of accumulated surfactant material in tissue is not to be expected, and indeed it is anticipated that APGs are rapidly eliminated and metabolised. Rapid biodegradation in the aquatic environment is considered to be a mitigating aspect, since the rates of biodegradation are significantly faster than the uptake rates of bioaccumulation.
Thus, the substance is not considered to be bioaccumulative (B) or very bioaccumulative (vB).
Toxicity
Long-term toxicity testing with Daphnia magna resulted in an EC10 value of 1.76 mg a.i./L for the category member D-Glucopyranose, oligomeric, C10 -C16 -alkyl glycosides (OECD 202 part II). Moreover, the substance is not classified according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008 (2nd ATP). 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.
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