Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
no hazard identified

Marine water

Hazard assessment conclusion:
no hazard identified

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
27 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
no hazard identified

Sediment (marine water)

Hazard assessment conclusion:
no hazard identified

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
no hazard identified

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

The test item is ‘readily biodegradable’ (10-day window not applicable to multi-constituent substances consisting of structurally similar constituents (OECD, 2006)).

The test item has a measured log Kow < 4.0 (consequential Bioconcentration Factor (BCF) is considered < 500 L/wt)

The test item does not indicate EC50/LC50 < 100 mg/L or EC10 (algae) or relevant NOEC in available studies as < 1 mg/L.

Relevant data available for aquatic toxicity are listed:

1. 48-h EC50 (invertebrates) : > 100 mg/L based on analytically confirmed nominal concentrations, freshwater, OECD TG 202, 2021

2. Read-Across: source data : Reaction products of 2-hydroxyethyl methacrylate and diphosphorus pentaoxide :

72-h ErC50 (aquatic algae; growth rate): = 165 mg/L based on TWA concentrations, 72 hour, freshwater, OECD TG 201, 2004

72-h NOErC (algae; growth rate): = 39 mg/L based on TWA concentrations, 72 hour, freshwater, OECD TG 201, 2004

Therefore:

72-h ErC50 (aquatic algae; growth rate): target : > 100 mg/L (or 165 mg/L) based on TWA concentrations, 72 hour, freshwater, OECD TG 201, 2021

72-h ErC10 (algae; growth rate) : target : > 39 mg/L based on TWA concentrations, 72 hour, freshwater, OECD TG 201, 2021

72-h NOErC (algae; growth rate): target : = 39 mg/L based on TWA concentrations, 72 hour, freshwater, OECD TG 201, 2021

3. Read-Across: source data : Reaction products of 2-hydroxyethyl methacrylate and diphosphorus pentaoxide :

96-h LC50 (fish) : > 100 mg/L based on analytically confirmed nominal concentrations, OECD TG 203, 2004

Therefore:

96-h LC50 (fish) : target : > 100 mg/L based on analytically confirmed nominal concentrations, freshwater, OECD TG 203, 2021

4. ASRIT:

Total Respiration Inhibition:

3h-EC50 = > 270 mg/L (nominal), 20 °C

3h-EC10 = - mg/L (nominal), 20°C

NOEC = 270 mg/L(nominal), 20 °C, OECD TG 209, 2021

 

Heterotrophic Respiration Inhibition:

3h-EC50 = > 270 mg/L (nominal), 20 °C

3h-EC10 = - mg/L (nominal), 20 °C

NOEC = 270 mg/L(nominal), 20 °C, OECD TG 209, 2021

 

Nitrification Inhibition:

3h-EC50 = > 810 mg/L (nominal), 20 °C

3h-EC10 = - mg/L (nominal), 20 °C

NOEC = 810 mg/L(nominal), 20 °C, OECD TG 209, 2021

5. Biodegradation: readily biodegradable, mean biodegradation 77% (28-days). 10 -day window not applicable to multi-constituent/UVCB substances consisting of structurally similar constituents (OECD, 2006); OECD TG 301B, 2018

6. log Pow (HPLC) : OECD TG 117, 2021

(i) at 35 °C pH 2: log Pow range = ≥ -0.8 to ≤ 2.8 ; with six peaks (two coeluting), respective log Pow: -0.8, 0.6 (coelution of two peaks), 2.3, 2.4 and 2.8

peak at log Pow - 0.8 (extrapolated) as beyond lower limit of calibration range: log Pow = 0.3 to 4.2

(ii) at 35 °C buffered pH 7: ≥ -2.0 to ≤ 2.8 ; with six peaks, and two eluting beyond the lower calibration range, respective log Pow: -2.0, 2.3, 2.4 and 2.8

peak at log Pow – 2.0 (extrapolated) as beyond lower limit of calibration range: log Pow = 0.3 to 4.2

The HPLC screening test confirms no constituents are expected to have a log Pow > 3.0 at pH 4, pH 7 or pH 9.

It can be considered that the test item consists of blocks of components that range from extremely low log Pow to low Pow at pH 4 to pH 7:

Block 3: log Pow = -2.0 to 0.6 (highly water soluble/essentially ‘miscible’, > 10000 mg/L)

Block 2: log Pow = 0.6 to 2.0 (water soluble, > 1000 mg/L)

Block 1: log Pow 2.1 to 2.8 (slightly soluble, 1 – 100 mg/L)

Supporting information:

Calculated log Kow (range): -1.7179 to 2.1995 in three blocks, respectively, at 25 °C; ca. pH 7, QSAR Prediction - KOWWIN v1.68, 2018

The majority of constituents had Log Kow = -0.7490 to 1.0627 and no constituents have predictions for Log Kow > 4.0.

Degradation references:

1. Introduction to the section of the OECD Guidelines for Testing of Chemicals on Degradation and Accumulation, Section 3 (OECD, September 2006)

2. ECHA Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.7b: Endpoint Specific Guidance, R.7.9.4, June 2017)

3. ECHA Guidance on Application on the CLP Criteria, section 4.1.3.2.3.2 (v5.0, July 2017)

4. GHS revision 4 (2011), Globally Harmonized System of Classification and Labelling of Chemicals (GHS). Chapter 4.1. Hazardous to the aquatic Environment. United Nations

5. Sub-Committee of Experts on the Globally Harmonized System of Classification and Labelling of Chemicals (2008). Updating of the second revised edition of the globally harmonized system of classification and labelling of chemicals (GHS) : 10-Day window: Technical support document to ST/SG/AC.10/CA/2008/27 UN/SCEGHS/16/INF.17

Conclusion on classification

The substance does not meet classification criteria under Regulation (EC) No 1272/2008 as hazardous to the aquatic environment.

 

The test item is ‘readily biodegradable’ (10-day window not applicable to multi-constituent substances consisting of structurally similar constituents (OECD, 2006)).

The test item has a measured log Kow < 4.0 (consequential Bioconcentration Factor (BCF) is considered < 500 L/wt)

The test item does not indicate EC50/LC50 < 100 mg/L or EC10 (algae) or relevant NOEC in available studies as < 1 mg/L.

 

References:

1. ECHA Guidance on Application on the CLP Criteria, (v5.0, July 2017)