Reaction mass of Dimethyl [3-[(hydroxymethyl) amino]-3-oxopropyl] phosphonate and Dimethyl (3-amino-3-oxopropyl)phosphonate

Biodegradation in water and sediment: simulation tests

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

biodegradation in water: sediment simulation testing

Data waiving:

exposure considerations

Justification for data waiving:

the study does not need to be conducted because direct and indirect exposure of sediment is unlikely

Transformation products:

no

Reference 2

Endpoint:

biodegradation in water: simulation testing on ultimate degradation in surface water

Data waiving:

other justification

Justification for data waiving:

other:

Transformation products:

no

Description of key information

In accordance with REACH Annex IV, Point 9.2.1.4, Column 2, the study does not need to be conducted as the direct and indirect exposure of sediment is unlikely.

Additional information

In accordance with REACH Annex IV, Point 9.2.1.4, Column 2, the study does not need to be conducted as the direct and indirect exposure of water and sediment is unlikely.

Biodegradation in water: simulation testing-

In accordance with Section 9.2 from ‘Column 2- SpecificRules for Adaptation from Column 1’given in Annex IX of Regulation (EC) No. 1907/2006 (REACH), further degradation testing shall be considered if the chemical safety assessment according to Annex I indicates the need to investigate further the degradation of the substance. Also, ECHA Guidance R7.9.2.3 (Chapter R.7b-Endpoint specific guidance, Version 4.0, June 2017) says, that the choice of the appropriate test(s) will depend on the results of the chemical safety assessment. If there is no exposure of water, or the exposure is so low that no refinement of the PECregional is required, then this test may not be necessary.Further, in accordance with Section 3.2(a) under ‘Substance Tailored Exposure Driven Testing’ given in Annex XI of Regulation (EC) No. 1907/2006 (REACH), the exposure assessment and chemical safety assessment fulfils the requirements for waiving of the biodegradation simulation testing in water as during the manufacturing process, during processing, and when used as flame retardant in end products; exposure to surface water is considered negligible, as nearly all wastewater from manufacturing and processing of DMPPA_701-402-5 is sampled and incinerated as hazardous waste. During the regular use of

DMPPA_701-402-5 fixed on technical textile surfaces (stable chemical bonding) no further exposure to the aquatic environment is expected to occur as no release from treated textile fabrics is taking place.Also, the risk for all the exposure scenarios for aquatic organisms (freshwater as well as marine water) is shown to be under control/acceptable during the chemical safety assessment, indicating no refinement of PECs (freshwater or marine water) is required. Thus, taking all the above information into account, the biodegradation simulation study in water is considered to be scientifically not necessary.

Biodegradation in sediment: simulation testing-

In accordance with Section 9.2 from ‘Column 2- Specific Rules for Adaptation from Column 1’given in Annex IX of Regulation (EC) No. 1907/2006 (REACH), further degradation testing shall be considered if the chemical safety assessment according to Annex I indicates the need to investigate further the degradation of the substance. Also, the section 9.2.1.3 (REACH, Annex IX) recommends that sediment simulation testing should be considered for substances with a high potential for adsorption to sediment. ECHA in its webinar‘How to bring your registration dossier in compliance with REACH, Tips and Hints - Part 5, Biodegradation’conducted on 12 February, 2014, has explained that those substances with log Koc >4 and log Kow >5 should be considered to have high adsorption potential to sediment. Also, ECHA Guidance R7.9.2.3 (Chapter R.7b-Endpoint specific guidance, Version 4.0, June 2017) says, that the choice of the appropriate test(s) will depend on the results of the chemical safety assessment. If there is no exposure of the soil/sediment, or the exposure is so low that no refinement of the PECregional is required, then this test may not be necessary. DMPPA_701-402-5 was found to have the log Kow equaling -1.68 and Koc values range from 176 (sand; LUFA 2.1) to 2005 (loamy sand; LUFA 2.2), these values point to low adsorption potential to sediment. Hence, a relevant distribution into sediment and a considerable exposure of sediment organisms is not expected.Further, in accordance with Section 3.2(a) under ‘Substance Tailored Exposure Driven Testing’ given in Annex XI of Regulation (EC) No. 1907/2006 (REACH), the exposure assessment and chemical safety assessment fulfils the requirements for waiving of the biodegradation simulation testing in sediment as during the manufacturing process, during processing, and when used as flame retardant in end products; exposure to sediment organism is considered negligible, as nearly all wastewater from manufacturing and processing of DMPPA_701-402-5 is sampled and incinerated as hazardous waste. During the regular use of DMPPA_701-402-5 fixed on technical textile surfaces (stable chemical bonding) no further exposure to the sediment environment is expected to occur as no release from treated textile fabrics is taking place.Also, the risk for all the exposure scenarios for sediment (freshwater as well as marine water) is shown to be under control/acceptable during the chemical safety assessment, indicating no refinement of PECsediment (freshwater or marine water) is required. Thus, taking all the above information into account, the sediment simulation study is considered to be scientifically not necessary.