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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

The assessment of PBT/vPvB properties has been done on the basis of the data available from the testing programme as well as from some calculated approaches.

Persistent assessment

To evaluate the persistence of "Sulfonation products of (esterification products of C9-11 (branched and linear) alkyl-(mono-, di- and tri-) glycosides with maleic anhydride) with disodium sulfite" a ready biodegradability study has been carried out. In the experiment, "Sulfonation products of (esterification products of C9-11 (branched and linear) alkyl-(mono-, di- and tri-) glycosides with maleic anhydride) with disodium sulfite" reached a degradation of 63% within 28 days. The test item is a surfactant as defined in Regulation 648/2004/EC: “any organic substance and/or mixture used in detergent, which has surface-active properties and which consist of one or more hydrophilic and one or more hydrophobic groups of such a nature and size that is capable of reducing the surface tension of water, and of forming spreading or adsorption monolayers at the water-air interface, and of forming emulsions and /or microemulsions and/or micelles, and of adsorption at water-solid interfaces”. Therefore, a surfactant shall be considered as biodegradable if the level of biodegradability is at least 60% within 28 days, irrespectively from 10-day window principle.

No hydrolysis test has been carried out, but the substance resulted readily biodegradable and the structural formula, although the content of ester and glycoside linkages that could be expected to undergo hydrolysis under extreme pH conditions,is not expected to significantlyundergo to hydrolysis under environmental conditions (pH range of 4 to 9).

As the substance is highly soluble (it is commercialized about 50% in water) and because in the environment it will mainly distribute into the aquatic compartment, no absorption/desorption test has been performed.

As a result of the previous considerations, “Sulfonation products of (esterification products of C9-11 (branched and linear) alkyl-(mono-, di- and tri-) glycosides with maleic anhydride) with disodium sulfite" will be mainly distributed in the aquatic compartment and it will not undergo to significant hydrolysis, but it will rapidlybiodegrade.

Therefore the substance does not meet the criteria of Annex XIII of Regulation EC 1907/2006 for the classification as “Persistent”.

Bioaccumulation assessment

As a result of the low value of logKOW, and considering the low bioaccumulation potential of alkyl polyglucosidesobserved inin vivostudieswith mice[1], “Sulfonation products of (esterification products of C9-11 (branched and linear) alkyl-(mono-, di- and tri-) glycosides with maleic anhydride) with disodium sulfite" is not expected to bioaccumulate in aquatic organisms.

On the basis of the above consideration, the substance is not expected to meet the criteria of Annex XIII of Regulation EC 1907/2006 for the classification as “Bioaccumulative”.

Toxicity assessment

Results of the acute toxicity studies on aquatic organisms provided the following low L(E) C50values: 15 mg/L, 46 mg/L, and 9.27 mg/L for fish (96 hours), daphnia (48 hours) and algae (96 hours), respectively. These values can be considered of moderate toxicity for aquatic organisms on a long-time scale, but it should be also considered that the substance will be rapidly removed from the aquatic compartment through a biotic pathway of degradation, and therefore the substance do not represent a cause of concern.

Furthermore, considering the results of the toxicological assessment, no toxic properties have been observed for “Sulfonation products of (esterification products of C9-11 (branched and linear) alkyl-(mono-, di- and tri-) glycosides with maleic anhydride) with disodium sulfite".

On the basis of the above consideration, it can be reasonably assumed that the substance does not meet the criteria of Annex XIII of Regulation EC 1907/2006 for the classification as “Toxic”.

Summary and overall conclusions on PBT or vPvB properties

On the basis of the available data, "Sulfonation products of (esterification products of C9-11 (branched and linear) alkyl-(mono-, di- and tri-) glycosides with maleic anhydride) with disodium sulfite", although environmental emissions are negligible, will mainly distribute into the aquatic compartment, whereit isexpected to degrade rapidly through a biotic pathway. Moreover, the substance is not expected to bioaccumulate and it is of low toxicity for aquatic organisms, as indicated by the short-term ecotoxicity studies on fish, crustaceans and algae.

In conclusion, considering all the available data, the substance does not meet the criteria of Annex XIII of Regulation EC 1907/2006 for the classification as “Persistent”, “Bioaccumulative” and “Toxic. Thereforethe "Sulfonationproducts of (esterification products of C9-11 (branched and linear) alkyl-(mono-, di- and tri-) glycosides with maleic anhydride) with disodiumsulfite" isnot considered to be neither a PBT nor a vPvB substance.

Emission characterization

Because the substance does not fulfil the PBT and vPvB criteria, no emission characterisation is performed

 

References

 1.        Hill, K., W.v. Rybinski, and G. Stoll,9. Toxicology of Alkyl Polyglucosides, inAlkyl Polyglucosides, Technology, Properties and Applications, VCH, Editor 1997: Weinheim - New York - Basel - Cambridge - Tokyo.