D-Glucopyranose, oligomeric, C10-14-alkyl glycosides tartaric esters, sodium salt

PBT assessment

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 " Esterification products of C10-14 (even numbered) alkyl oligomeric glycosides with tartaric acid, sodium salt" a ready biodegradability study has been investigated.

 

In the experiment, " Esterification products of C10-14 (even numbered) alkyl oligomeric glycosides with tartaric acid, sodium salt" reached a degradation > 90% within 29 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 significantly undergo 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, "

"Esterification products of C10-14 (even numbered) alkyl oligomeric glycosides with tartaric acid, sodium salt"

" will be mainly distributed in the aquatic compartment and it will not undergo to significant hydrolysis, but it will rapidly biodegrade.

 

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 log KOW, and considering the low bioaccumulation potential of alkyl Polyglucosides observed in in-vivo studies with mice[1], "Esterification products of C10-14 (even numbered) alkyl oligomeric glycosides with tartaric acid, sodium salt"

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 study on aquatic organisms provided the following low L(E)C50 values:

5.2 mg/L for Daphnia Magna (48 hours), 10.2 mg/L for Artemia Salina (24 hours), in no GLP studies: Full investigation was carried out similar alkylpolyglucoside esters, in read across approach showing L(E)C50 values:  46 mg/L, and 9.27 mg/L for fish (Rainbow trout–Oncorhynchus mykiss 96-h LC50=6.75 mg/L at 96 hours), and Algae (Selenastrum capricornutum -72h EC50= 4.2 mg/L Biomass; 72h EC50= 7.6 mg/L Growth) obtained in experiments on other Alkypolyglucoside ester: DGlucopyranose,

oligomeric, 6-(hydrogen 2-sulfobutanedioate), 1-(coco alkyl) ether, sodium salt(CAS

No.151911-53-4)

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 concern for the environment.

Furthermore, considering the results of the toxicological assessment, no toxic properties have been

observed for "

"Esterification products of C10-14 (even numbered) alkyl oligomeric glycosides with tartaric acid, sodium salt"

".

 

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, " Esterification products of C10-14 (even numbered) alkyl oligomeric glycosides with tartaric acid, sodium salt", although environmental emissions are negligible, will mainly distribute into the aquatic compartment, where it is expected 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.

 

Therefore the "

"Esterification products of C10-14 (even numbered) alkyl oligomeric glycosides with tartaric acid, sodium salt"

" is not 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, in Alkyl Polyglucosides, Technology, Properties and Applications, VCH, Editor 1997: Weinheim - New York - Basel – Cambridge