Registration Dossier

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Administrative data

Endpoint:
adsorption / desorption: screening
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
The performance of a test for adsorption/desorption screening is scientifically unjustified. REACh Regulation (EC) No 1907/2006, Annex VIII, Sect. 9.3.1, Col. 2, states as follows:

“9.3.1 The study need not be conducted if:
- based on the physicochemical properties the substance can be expected to have a low potential for adsorption (e.g. the substance has a low octanol water partition coefficient), or
- the substance and its relevant degradation products decompose rapidly.”

Direct and indirect exposure to the aquatic and soil compartments is highly unlikely, as HAT-ISO is manufactured and formulated in closed systems. Thus, direct and indirect exposure of the aquatic or soil compartments during manufacturing and formulation is practically negligible. Use of formulated HAT-ISO is also unlikely to result in direct and indirect exposure to the aquatic or soil compartments. During use HAT-ISO is included in three-dimensional matrices of polymeric, resinous material and completely retained. Therefore, the direct and indirect release of HAT-ISO into the aquatic or soil compartments is practically negligible. For more details on exposure assessment see the risk assessment report included in section 13.
Further, HAT-ISO is highly insoluble in water. The solubility was determined at 0.0497 mg/L at 20 °C. Thus, availability of HAT-ISO to the aquatic environment and bioaccumulation in e.g. fish is practically negligible and highly unlikely. Nevertheless, the adsorption potential of HAT-ISO was estimated using the US EPA Epiwin (v.3.12) software. The soil adsorption coefficient was calculated at Koc = 1.78E+05 and Log Koc = 5.251. In summary, the direct and indirect exposure of the aquatic and soil environment to HAT-ISO is not likely, the substance is insoluble and the adsorption coefficient was estimated. Therefore, performance of a test for adsorption/desorption screening is scientifically unjustified.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion