Registration Dossier
Registration Dossier
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EC number: 404-310-0 | CAS number: 10591-85-2 PERKACIT TBZTD; PERKACIT TBZTD PDR; PERKACIT TBZTD PDR-D; TBZD
Endpoint summary
Administrative data
Description of key information
TBzTD is not readily biodegradable (2% biodegradation after 28d in EU method C.5 study)
No further degradation study required: TBzTD is not PBT nor vPvB.
Additional information
Ready biodegradation - Modified Sturm test
TBzTD is not biodegraded in the modified Sturm test according to Directive EEC 84/488/EE, Part C. Methods for the determination of ecotoxicity, C. 5 Degradation biotic degradation: Modified Sturm test. Lack of ready biodegradation does not mean that TBzTD is recalcitrant in nature. Firstly, the water insolubility and secondly the stringency of the test procedures could account for the recalcitrance of TBzTD in the Sturm test. TBzTD is probably not toxic in the Sturm test because the endogenous carbon dioxide production is hardly or not affected by TBzTD. TBzTD should, therefore, not be classified as readily biodegradable.
Biodegradation in water and sediment: simulation tests
Data waiving:
According to columns 1 and 2 of Annex IX of REACH regulation EC 1907/2006, biotic degradation testing in water shall be proposed by the registrant to investigate further the degradation of the substance and its degradation products.
A well-documented and reliable QSAR approach was adopted in order to evaluate the biotic degradation potential of the parent substance and its degradation products. The estimated biowin screening values indicate that two structures have a potential of persistency. In addition, none of the test substance and all the identified degradation products is B, nor vB. According to the PBT/vPvB assessment, the substance and its identified degradation products are therefore not considered PBT/vPvB.
In addition, according to the chemical risk assessment, the risks for water, sediment and soil compartments are considered all acceptable (all RCR are below 1 in all exposure scenarios). Therefore, the CSA does not indicate the need to investigate further hazards and risks for water, sediment and soil compartments, nor that further degradation testing is necessary in water, sediment soil compartments.
In conclusion, the study is therefore waived in compliance with column 2 of annexes IX and X of REACh regulation EC 1907/2006.
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