Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

Administrative data

PBT assessment: overall result

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

8. PBT AND vPvB ASSESSMENT

 

8.1. Assessment of PBT/vPvB properties

 

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 methyl 3-α,7-α-diacetoxy-12-oxo-5-β-cholan-24-oate, a ready biodegradability study has been carried out with the similar substance ursodeoxycholic acid and results have been used in a read-across approach to evaluate the persistence in water of methyl 3-α,7-α-diacetoxy-12-oxo-5-β-cholan-24-oate. In the experiment, the similar substance ursodeoxycholic acid reached 53.4% of degradation after the 10-d window, and 82% after 28 days. The test item, although it is not used in detergents, 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.

To determinate the abiotic degradation hydrolysis of methyl 3-α,7-α-diacetoxy-12-oxo-5-β-cholan-24-oate, a test on the similar substance ursodeoxycholic acid has been performed according to C.7 method in Council Regulation (EC) No 440/2008 of 30 May 2008 and OECD guideline No. 111. The results of the preliminary test showed that less than 50% of the test item has been hydrolysed in 2.4 hours at, and that less than 10% of the test item has been hydrolysed after five days for the three pH values. According to guideline dispositions, the full test was not performed and it can be concluded that the abiotic degradation hydrolysis of the similar substance ursodeoxycholic acid is lower than 10% after 5 days atfor the pH values 4, 7 and 9.

Therefore, according to a read-across approach, methyl 3-α,7-α-diacetoxy-12-oxo-5-β-cholan-24-oate is not expected to hydrolyzed if released into the environment.

As a result of the previous considerations, methyl 3-α,7-α-diacetoxy-12-oxo-5-β-cholan-24-oate, if released into the aquatic compartment, will not undergo to significant hydrolysis, but it will rapidly biodegraded.

Therefore the substances do not meet the criteria of Annex XIII of Regulation EC 1907/2006 for the classification as “Persistents”.

  

Bioaccumulation assessment

 

As a result of the values of logKOW, and considering the available toxicokinetics data, methyl 3-α,7-α-diacetoxy-12-oxo-5-β-cholan-24-oate is not expected to bioaccumulate in aquatic organisms.

On the basis of the above consideration, the substances are 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 showed that the similar substance ursodeoxycholic acid and, according to a read-across principle methyl 3-α,7-α-diacetoxy-12-oxo-5-β-cholan-24-oate, have a moderate to low aquatic toxicity. Considering that the substances are also readily biodegradable, methyl 3-α,7-α-diacetoxy-12-oxo-5-β-cholan-24-oate will be rapidly removed from the aquatic compartment, and it is not a cause of concern.

Furthermore, considering the results of the toxicological assessment, no toxic properties have been observed for methyl 3-α,7-α-diacetoxy-12-oxo-5-β-cholan-24-oate.

On the basis of the above consideration, it can be reasonably assumed that methyl 3-α,7-α-diacetoxy-12-oxo-5-β-cholan-24-oate do 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

 

Although environmental emissions are not foreseen in view of its use, methyl 3-α,7-α-diacetoxy-12-oxo-5-β-cholan-24-oate is considered to be readily biodegradable if released in water. Moreover, the substance is not expected to bioaccumulate and it is expected to be of low toxicity for aquatic organisms, as indicated by the short-term ecotoxicity studies on fish, crustaceans and algae performed with the similar substance ursodeoxycholic acid.

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, methyl 3-α,7-α-diacetoxy-12-oxo-5-β-cholan-24-oate is not considered to be neither a PBT nor a vPvB substance.

 

8.2. Emission characterization

 

Because the substances do not fulfil the PBT and vPvB criteria, no emission characterisation is performed. Furthermore on the basis of the risk characterisation, the risk is evaluated as adequately controlled during all steps of life cycle.

Likely routes of exposure:

Methyl 3-α,7-α-diacetoxy-12-oxo-5-β-cholan-24-oate is used as intermediate in the synthesis of other substances, under controlled conditions. No significant release to the environment is expected, then human exposure is evaluated as unlikely and not significant.