Registration Dossier

Administrative data

Endpoint:
bioaccumulation: aquatic / sediment
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:

Data source

Materials and methods

GLP compliance:
yes (incl. certificate)

Test conditions

Reference substance (positive control):
not specified

Results and discussion

Applicant's summary and conclusion

Conclusions:
The registered substance is produced, supplied and marketed in the presence of a liquid mineral oil solvent. Removal of this solvent is expected to cause a change in the equilibrium of the chemical structure of the alkyrated benzene sulfonates resulting in a degradation of the chemical structure to a structure that is not representative of the substance being placed on the market in the EU. Based on QSAR, the partition coefficient of the substance is considered to be 30.97.
A partition coefficient in excess of 3 is considered to be of concern as potential for bioaccumulation. The likely reliability of the log Pow is, however, considered to diminish above a value of 6. Substances with log Pow between 3 and 6 are classified highly accumulating; however no substantial bioconcentration is assumed for compounds having log Pow with values less than 3 or greater than 6. For compounds having log Pow greater than 6, a gradual decrease of the BCF is observed. It has been hypothesised within the published literature that a high log Pow is more an effect of solubility than a tendency of the substance to be lipophilic.
This observation is further supported by QSAR evaluation of the substance which suggests that the BCF of the substance is 70.79, considerably below the threshold of concern of 500.
It is therefore considered that the substance is considered to not have the potential to bioaccumulate and it is therefore not scientifically justified to undertake a study in fish.
Executive summary:

The registered substance is produced, supplied and marketed in the presence of a liquid mineral oil solvent. Removal of this solvent is expected to cause a change in the equilibrium of the chemical structure of the alkyrated benzene sulfonates resulting in a degradation of the chemical structure to a structure that is not representative of the substance being placed on the market in the EU. Based on QSAR, the partition coefficient of the substance is considered to be 30.97. 

A partition coefficient in excess of 3 is considered to be of concern as potential for bioaccumulation. The likely reliability of the log Pow is, however, considered to diminish above a value of 6. Substances with log Pow between 3 and 6 are classified highly accumulating; however no substantial bioconcentration is assumed for compounds having log Pow with values less than 3 or greater than 6. For compounds having log Pow greater than 6, a gradual decrease of the BCF is observed. It has been hypothesised within the published literature that a high log Pow is more an effect of solubility than a tendency of the substance to be lipophilic.

This observation is further supported by QSAR evaluation of the substance which suggests that the BCF of the substance is 70.79, considerably below the threshold of concern of 500.

It is therefore considered that the substance is considered to not have the potential to bioaccumulate and it is therefore not scientifically justified to undertake a study in fish.