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Environmental fate & pathways

Biodegradation in soil

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Reference
Endpoint:
biodegradation in soil: simulation testing
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because direct and indirect exposure of soil is unlikely
Justification for type of information:
The performance of a simulation test on biodegradation in soil is scientifically unjustified.
REACh Regulation (EC) No 1907/2006, Annex IX as well as Annex X, Sect. 9.2 Col. 2, states as follows: "Further biotic degradation testing shall be proposed by the registrant if the chemical safety assessment according to Annex I indicates the need to investigate further the degradation of the substance and its degradation products. The choice of the appropriate test(s) depends on the results of the chemical safety assessment and may include simulation testing in appropriate media (e.g. water, sediment or soil)."

Furher, Section 9.2.1.3 specifically states that
" The study need not be conducted:
— if the substance is readily biodegradable, or
— if direct and indirect exposure of soil is unlikely.”

Direct and indirect exposure of the environment is highly unlikely, as HAT ISO is manufactured and formulated in closed systems. Thus, direct and indirect exposure to the environment during manufacturing and formulation is practically negligible. Use of formulated HAT ISO is also unlikely to result in direct and indirect exposure of the environment. 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 to the environment is practically negligible. For more details on exposure assessment see the chemical safety report included in IUCLID section 13. In summary, direct and indirect exposure of HAT-ISO to the environment is unlikely and the chemical safety assessment does not indicate the need to further investigate degradation of the test item. Thus, simulation tests on biodegradation is scientifically unjustified.
Transformation products:
no

Description of key information

The performance of a simulation test on biodegradation in soil is scientifically unjustified.

Key value for chemical safety assessment

Additional information

The performance of a simulation test on biodegradation in soil is scientifically unjustified.

REACh Regulation (EC) No 1907/2006, Annex IX as well as Annex X, Sect. 9.2 Col. 2, states as follows: "Further biotic degradation testing shall be proposed by the registrant if the chemical safety assessment according to Annex I indicates the need to investigate further the degradation of the substance and its degradation products. The choice of the appropriate test(s) depends on the results of the chemical safety assessment and may include simulation testing in appropriate media (e.g. water, sediment or soil)."

 

Furher, Section 9.2.1.3 specifically states that

" The study need not be conducted:

— if the substance is readily biodegradable, or

— if direct and indirect exposure of soil is unlikely.”

 

Direct and indirect exposure of the environment is highly unlikely, as HAT ISO is manufactured and formulated in closed systems. Thus, direct and indirect exposure to the environment during manufacturing and formulation is practically negligible. Use of formulated HAT ISO is also unlikely to result in direct and indirect exposure of the environment. 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 to the environment is practically negligible. For more details on exposure assessment see the chemical safety report included in IUCLID section 13. In summary, direct and indirect exposure of HAT-ISO to the environment is unlikely and the chemical safety assessment does not indicate the need to further investigate degradation of the test item. Thus, simulation tests on biodegradation is scientifically unjustified.