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

Long-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

long-term toxicity to aquatic invertebrates

Data waiving:

other justification

Justification for data waiving:

other:

Description of key information

The ‘Column 2: Specific Rules for Adaptation from Column 1’ given in Annex IX of Regulation (EC) No. 1907/2006 (REACH) states that, the long-term toxicity testing shall be proposed by the registrant if the chemical safety assessment according to Annex I indicates the need to investigate further the effects on aquatic organisms. The choice of the appropriate test(s) depends on the results of the chemical safety assessment. In accordance with this provision, long term toxicity test with invertebrates is considered to be scientifically not necessary as the chemical safety assessment performed using the available information from short term and chronic aquatic toxicity tests (96h LC50 to fish: >1000 mg/L; 48h EC50 to Daphnids: 1600 mg/L; 72h EC50 to algae: 184 mg/L and 72h NOEC to algae 50.6 mg/L) indicates no hazard is to be expected to aquatic invertebrates. This conclusion was further supported by estimation of chronic value to fish using ECOSAR v2. The lowest chronic value to daphnia was estimated to be > 20000 mg/L based on Ecosar estimation. This value may be considered not to be conservative as the chemical safety assessment performed with the algal EC50 184 mg/L and the application of assessment factor 10000 will result in lower or more conservative estimate of PNECs.

Predicted Ecotox values using the Estimation Programs Interface (EPI) SuiteTM developed by the US Environmental Protection Agency's Office of Pollution Prevention and Toxics and Syracuse Research Corporation (SRC).

Sl. No	Parameter	QSAR tool used for prediction	Endpoint value
1	Chronic toxicity to Fish	ECOSAR Version 2	ChV: 771.59 mg/l
2	Chronic toxicity to Daphnia	ECOSAR Version 2	ChV: 29475.47mg/l
3	Chronic toxicity to Green Algae	ECOSAR Version 2	ChV: 10462.01 mg/l

 

 

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 long term aquatic toxicity tests as discussed below:

i) No significant exposure to aquatic species is expected from all exposure scenarios of DMPPA_701-402-5, as nearly all wastewater from manufacturing and processing is sampled and incinerated as hazardous waste. Also no uses for professional workers and/or consumers are advised.

ii) The Predicted No Effect Concentrations (PNECs) were derived from available aquatic toxicity studies using the most sensitive endpoint (72h EC50 to algae: 184.8 mg/L). To account for the uncertainty arising out of using of a short term toxicity value instead of a long term value, a large assessment factor (1000 instead of 100 for freshwater species and 10000 instead of 1000 for marine water species) was used.

iii) The PECs from exposure assessment were always below the derived PNECs using aquatic toxicity data (0.184 mg/L for freshwater species; 0.0184 mg/L for marine water species). Hence, this resulted in RCRs for all exposure scenarios being less than 0.13.

Thus taking into account the provisions of ‘Specific Rules for Adaptation’ from Annex IX and Section 3.2(a) under ‘Substance Tailored Exposure Driven Testing’ from Annex XI of REACH Regulation, the long term toxicity testing with invertebrates is considered to be scientifically not necessary and waived off.