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Description of key information

DEGDB:

Short-term toxicity to fish:

- Key study, reliability 1, OECD 203, rainbow trout - LC50 (96h) = 1.12 mg/L

- Supporting study, reliability 1, OECD 203, fathead minnow - LC50 (96h) = 1.85 mg/L

Short-term toxicity to aquatic invertebrates:

- Key study, reliability 1, OECD 202, Daphnia magna - EC50 = 3.05 mg/L

Toxicity to aquatic algae and cyanobacteria:

- Study in progress

- Disregarded study, reliability 3, OECD 201, Pseudokirchneriella subcapitata - The test substance was not anaytically detected at the end of the study and therefore it was determined that the geometric mean of the exposure concentrations was unreliable and the study should be repeated.

Toxicity to microorganisms:

- Key study, reliabiltiy 1, OECD 209, activated sludge of a predominantly domestic sewage - EC50 (3 h) > 100 mg/L and NOEC (3 h) >= 100 mg/L

- Supporting study, reliability 2, ISO 10712 Determination of the inhibitory effect of water constituents on bacteria Pseudomonas cell multiplication inhibition test, Pseudomonas putida - EC10 and EC50 > 10 mg/L, NOEC >= 10 mg/L

DPGDB:

Short-term toxicity to fish:

- Key study, reliability 1, OECD 203, fathead minnow - LC50 (96h) = 3.7 mg/L

- Supporting study, reliability 1, OECD 203, rainbow trout - LC50 (96h) > 3.0 mg/L

- Supporting study, reliability 2, QSAR calculation (EPIWIN-ECOSAR v1.00) - LC50 = 3.94 mg/L

- Disregarded study, reliability 3, OECD 203, fathead minnow - LL50 > 100 mg/L, NOELR = 0.8 mg/L, poor correlation of nominal levels with measured concentrations

- Disregarded study, reliability 3, OECD 203, rainbow trout - LL50 = 0.25 mg/L, NOELR = 0.06 mg/L, poor correlation of nominal levels with measured concentrations

Short-term toxicity to aquatic invertebrates:

- Key study, reliability 1, OECD 202, Daphnia magna - EC50 = 5.0 mg/L

Long-term toxicity to aquatic invertebrates

- Key Study, reliability 1, OECD 211, Daphnia magna: LOEC (reproduction & length) = 5.6 mg/L, NOEC (reproduction & length) = 2.2 mg/L, EC10 (reproduction) = 2.5 mg/L, EC10 (length) = >5.6 mg/L

Toxicity to aquatic algae and cyanobacteria:

- Key study, reliability 1, OECD 201, Pseudokirchneriella subcapitata - The EbC50 (biomass 72 h) was 0.70 mg/L and the ErC50 (Growth rate 0 - 72 h) was 3.2 mg/L. The EbC50 (biommass 96 h) was 0.62 mg/L and the EbC50 (Growth rate 0 - 96 h) was 2.5 mg/L.

The 72 and 96 hour "no-observed effect concentrations" (NOEC) for growth rate were 0.68 and 0.27 mg/L, respectively.

Toxicity to microorganisms:

- Key study, reliabiltiy 1, OECD 209, activated sludge of a predominantly domestic sewage - EC50 (3 h) > 100 mg/L and NOEC (3 h) >= 100 mg/L

- Supporting study, reliability 1, ISO 10712 Determination of the inhibitory effect of water constituents on bacteria Pseudomonas cell multiplication inhibition test, Pseudomonas putida - EC10 and EC50 > 10 mg/L, NOEC >= 10 mg/L

TEGDB

Short-term toxicity to fish:

- Key study, reliability 1, OECD 203, rainbow trout - LC50 (96h) = 4.3 mg/L

- Supporting study, reliability 2, OECD 203, fathead minnow - LC50 (96h) > 5.8 mg/L

Short-term toxicity to aquatic invertebrates:

- Key study, reliability 1, OECD 202, Daphnia magna - EC50 (48h) = 9.0 mg/L

Toxicity to aquatic algae and cyanobacteria:

- Study in progress

- Disregarded study, reliability 3,OECD 201, Pseudokirchneriella subcapitata - The test substance was not anaytically detected at the end of the study and therefore it was determined that the geometric mean of the exposure concentrations was unreliable and the study should be repeated.

Toxicity to microorganisms:

- Key study, reliabiltiy 1, OECD 209, activated sludge of a predominantly domestic sewage - EC50 (3 h) > 100 mg/L and NOEC (3 h) >= 100 mg/L

- Key study, reliability 2, ISO 10712 Determination of the inhibitory effect of water constituents on bacteria Pseudomonas cell multiplication inhibition test, Pseudomonas putida - EC10 and EC50 > 10 mg/L, NOEC >= 10 mg/L

Toxicity to aquatic algae and cyanobactor tests with DEGDB and TEGDB are in progress to fulfil those endpoints for the reaction mass, and a long-term toxicity to fish study with DEGDB is proposed to further refine the key values used in the chemical safety assessment.

The current key values used in the chemical safety assessment are:

Short-term aquatic toxicity EC/LC50 = 1.12 mg/L (DEGDB rainbow trout)

Long-term aquatic toxicity NOEC = 0.68 mg/L (DPGDB, 72 hour algal growth rate)

Toxicity to micro-organisms = 100 mg/L

Additional information

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