Registration Dossier
Registration Dossier
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EC number: 416-600-4 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Based on the results of three screening tests, the test item is considered to not be readily biodegradable. Further simulation testing is not required according to Column 2 Section 9.2 of REACH Annex IX and X.
Additional information
Biodegradation in water: screening test
The test substance was tested for biotic degradation in the carbon dioxide evolution test according to EU Guideline C.4 and in the aerobic biodegradation test according to the guidelines ISO 14953 and ISO 10634. HAT-ISO showed a biodegradation of 11 % within 28 days in the carbon dioxide evolution test. In the CO2 Headspace test, according to the ISO standards, HAT-ISO showed a biodegradation of < 10 % within 28 days. Because the test substance was not biodegraded in the above mentioned tests, a supplementary test (LAUS, 2015) with supposed better conditions for the biodegradation (mixed population of microorganisms as inoculum, solvent and surface-active agent used) was conducted according to the OECD 310 (CO2-Headspace Test). In this test the test substance was degraded by 0.4 % (mean value) after 28 days. Based on the available data and the test results, the test substance was determined to be not readily biodegradable under the test conditions.
Biodegradation in surface water
The performance of a simulation test on biodegradation in surface water 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 9.2.1.2 specifically states that
" The study need not be conducted if:
— the substances is highly insoluble in water, or
— the substance is readily biodegradable.”
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. Further, the substance is considered to be highly insoluble in water.
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.
Biodegradation in sediment
The performance of a simulation test on biodegradation in sediment 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 9.2.1.4 specifically states that
" The study need not be conducted:
— if the substance is readily biodegradable, or
— if direct and indirect exposure of sediment 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.
Biodegradation in soil
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.
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