Registration Dossier

Environmental fate & pathways

Biodegradation in water and sediment: simulation tests

Currently viewing:

Administrative data

Link to relevant study record(s)

Referenceopen allclose all

Endpoint:
biodegradation in water: simulation testing on ultimate degradation in surface water
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint:
biodegradation in water: sediment simulation testing
Data waiving:
other justification
Justification for data waiving:
other:

Description of key information

According to Column 9.2 of REACH Annex IX, further degradation testing (including simulation testing in appropriate media, e.g. water, sediment or soil) shall only be considered if it is demonstrated in the chemical safety assessment (according to Annex I) that it is necessary to further investigate the degradation of the substance and its degradation products.  

Available experimental ecotoxicity test data has demonstrated very low ecotoxicity of di-trimethylolpropane (fish 96 hour LC50: >1000 mg/L; aquatic invertebrate 48 hour EC50: 3560 mg/L; algae 72 hour EC50: >1000 mg/L). No adverse effects were observed at the highest recommended concentrations tested, thereby indicating that no hazard has been identified and that PNEC values would not need to be derived (ECHA, 2011) (although for completeness, PNECs have been derived regardless). Moreover, the substance does not fulfil the criteria for being regarded as PBT or vPvB, nor is direct release of the substance into the environment anticipated. Consequently, according to the chemical safety assessment performed according to Article 14(3) in connection with Annex I section 3 (Environmental Hazard Assessment), no environmental risk assessment is required under REACH.

It is therefore not considered necessary to further investigate the degradation of di-trimethylolpropane or its degradation products in water and sediment, as per Column 9.2 of REACH Annex IX.

Key value for chemical safety assessment

Additional information

ECHA, 2011. ECHA Guidance on information requirements and chemical safety assessment Part B: Hazard Assessment. Helsinki: ECHA.