Reaction products of 2-hydroxyethyl methacrylate and diphosphorous pentoxide and water

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From April 29, 2004 to May 28, 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: ISO International Standard 7346-2: “Water quality – Determination of the acute lethal toxicity of substances to a freshwater fish [Brachydanio rerio Hamilton-Buchanan (Teleostei, Cyprinidae)]” – Part 2: Semi-static method, Second edition, 1996-06-15.

Deviations:

yes

Remarks:

but the study was not adversely affected by this deviation

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

The analytical results showed that measured test substance concentrations in samples taken from nominally 100 mg/L decreased from 96 mg/L at the start to 79 mg/L after 24 hours and to 32 mg/L after 96 hours of exposure. Consequently, it was decided to continue with renewal of test solutions after each 24h period to maintain concentrations at > 80% relative to initial.
Sampling: frequency at t=0 h, t=24 h and t=96 h. Volume 10 ml from the approximate centre of the test vessels. Storage Samples were stored in a freezer until analysis.
Preparation of test solutions started with a stock solution of 100 mg/L applying 15 minutes of magnetic stirring to accelerate the dissolving of the test substance in the test medium. The lower test concentrations for the range-finding test were prepared by subsequent dilutions of the stock in test medium. Test solutions were renewed after each 24-hour interval during the limit test. The final test solutions were all clear and colourless.

Vehicle:

yes

Details on test solutions:

A combined limit/range-finding test was performed. The project started with a static range-finding test exposing three carp per concentration to nominal test concentrations concentrations of 0.1, 1.0, 10 and 100 mg/L. No effects were observed during the test period up to and including 100 mg/L. The project was continued with a limit test exposing seven carp per concentration to a blank control and a nominal test substance concentration of 100 mg/L applying a semi-static test design. Samples for analyses were taken from the freshly prepared solutions at the start and after 72 hours and from 24-hour spent solutions after 24 and 96 hours of exposure.

Test organisms (species):

Cyprinus carpio

Details on test organisms:

Species: Carp (Cyprinus carpio, Teleostei, Cyprinidae) Linnaeus, 1758
Source: Zodiac, proefacc, "De Haar Vissen", L.U. Wageningen, the Netherlands.
Mean length: 2.3 ± 0.2 cm.
Mean weight: 0.30 ± 0.10 g.
Characteristics: F1 from a single parent-pair bred in UV-treated water.
Reason for selection: this system has been selected as an internationally accepted species.
Total fish used: 26

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Post exposure observation period:

No

Hardness:

250 mg CaCO3 per litre

Test temperature:

20.9- 22.1°C

pH:

6.1 - 6.5

Dissolved oxygen:

Oxygen > 60% of air saturation value

Salinity:

-

Conductivity:

-

Nominal and measured concentrations:

0.1, 1.0, 10 and 100 mg/L (nominal concentrations)

Details on test conditions:

Test vessels: 6.5 litres, all-glass, containing 5 litres of test medium.
Test medium: ISO-medium, aerated until the dissolved oxygen concentration had reached saturation and the pH had stabilised
Number of fish: 7 fish per concentration and control
Loading: 0.39 g fish/litre, i.e. 7 fish per 5 litres of test medium
Illumination: 16 hours photoperiod daily
Aeration: the test media were not aerated during the test
Feeding: no feeding from 48 hours prior to the test and during the total test period
Introduction of fish: within ¾ hour after preparation of the test media
Euthanasia: at the end of the test the surviving fish were rapidly killed by exposing them to ca. 1.2% ethylene glycol monophenylether in water.

Reference substance (positive control):

yes

Remarks:

pentachlorophenol (PCP, concentrations: 0.10, 0.22 and 0.46 mg/L in ISO-medium)

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: LC50 could not be calculated because the test substance proved to be non-toxic

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: No mortality or clinical effects were observed in the limit test.

Details on results:

No LC50 could be calculated because the test substance proved to be non-toxic (LC50 > maximum concentration tested). No mortality or clinical effects were observed during the limit test.

Results with reference substance (positive control):

PCP induced no lethal effects in carp at or below 0.22 mg/L. The 96h-LC50 for carp exposed to PCP was 0.32 mg/L (95 % confidence interval between 0.22 and 0.46 mg/l) and already reached within 24 hours of exposure. The range of the 96hLC50 for carp is generally between 0.10 and 0.46 mg/l based on historical data of reference tests performed approximately every 3 months from April 1988 until the end 2000, and annually since then. The response observed in carp originating from the present batch falls within this range.

Sublethal observations / clinical signs:

- Analysis of the samples taken during the limit test showed that measured concentrations were in agreement with nominal in both the freshly prepared solutions and the 24-hour spent solutions. Recoveries ranged between 87 and 97% of nominal. Hence, further results were based on nominal concentrations.

Validity criteria fulfilled:

yes

Conclusions:

Under the study conditions, the 96h LC50 and NOEC for carp (Cyprinus carpio) were determined to be: > 100 mg/L and 100 mg/L, respectively.

Executive summary:

A study was conducted to determine the short-term toxicity of the test substance to fish according to OECD guideline 203, EU Method C.1 and ISO 7346 -2. Carp were exposed to the test substance at concentrations of 0.1, 1.0, 10 and 100 mg/L (nominal) for 96 h under static conditions. Samples for analytical confirmation were taken from the freshly prepared solutions at the start and after 72 h and from 24-h spent solutions after 24 and 96 h of exposure. Mortality and other effects were observed at 2¾, 24, 48, 72 and 96 h following the start of exposure. Analysis of the samples taken during the limit test showed that measured concentrations were in agreement with nominal in both the freshly prepared solutions and the 24-h spent solutions. Recoveries ranged between 87 and 97% of nominal. Hence, further results were based on nominal concentrations. The test substance induced no visible effects in carp at or below 100 mg/L (NOEC). Hence, no LC50 could be calculated (i.e., LC50 > maximum concentration tested). The study met the acceptability criteria prescribed by the protocol and was considered valid. Under the study conditions, the 96 h EC50 for carp (Cyprinus carpio) was considered to be >100 mg/L and the 96 h NOEC at 100 mg/L (Migchielsen, 2004).

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

29-04-2004 to 28-05-2004

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included in attachment to IUCLID section 13.

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The read-across is based on the hypothesis that the source and target substances have common structural features in the same relative positions. The source and target have similar physico-chemical, toxicological properties and because of common metabolism they share common or have similar breakdown products and therefore potential mechanisms of action. Further information is included in attachment to IUCLID section 13.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
The source and target chemicals have comparable chemical similarity. Further information is included in attachment to IUCLID section 13

3. ANALOGUE APPROACH JUSTIFICATION
The source substance is a chemically similar substance with common metabolism and common or similar degradants of the target substance. Further information is included in attachment to IUCLID section 13

4. DATA MATRIX
Further information is included in attachment to IUCLID section 13.

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: ISO International Standard 7346-2: “Water quality – Determination of the acute lethal toxicity of substances to a freshwater fish [Brachydanio rerio Hamilton-Buchanan (Teleostei, Cyprinidae)]” – Part 2: Semi-static method, Second edition, 1996-06-15.

Deviations:

yes

Remarks:

but the study was not adversely affected by this deviation

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

The analytical results showed that measured test substance concentrations in samples taken from nominally 100 mg/L decreased from 96 mg/L at the start to 79 mg/L after 24 hours and to 32 mg/L after 96 hours of exposure. Consequently, it was decided to continue with renewal of test solutions after each 24h period to maintain concentrations at > 80% relative to initial.
Sampling: frequency at t=0 h, t=24 h and t=96 h. Volume 10 ml from the approximate centre of the test vessels. Storage Samples were stored in a freezer until analysis.
Preparation of test solutions started with a stock solution of 100 mg/L applying 15 minutes of magnetic stirring to accelerate the dissolving of the test substance in the test medium. The lower test concentrations for the range-finding test were prepared by subsequent dilutions of the stock in test medium. Test solutions were renewed after each 24-hour interval during the limit test. The final test solutions were all clear and colourless.

Vehicle:

yes

Details on test solutions:

A combined limit/range-finding test was performed. The project started with a static range-finding test exposing three carp per concentration to nominal test concentrations concentrations of 0.1, 1.0, 10 and 100 mg/L. No effects were observed during the test period up to and including 100 mg/L. The project was continued with a limit test exposing seven carp per concentration to a blank control and a nominal test substance concentration of 100 mg/L applying a semi-static test design. Samples for analyses were taken from the freshly prepared solutions at the start and after 72 hours and from 24-hour spent solutions after 24 and 96 hours of exposure.

Test organisms (species):

Cyprinus carpio

Details on test organisms:

Species: Carp (Cyprinus carpio, Teleostei, Cyprinidae) Linnaeus, 1758
Source: Zodiac, proefacc, "De Haar Vissen", L.U. Wageningen, the Netherlands.
Mean length: 2.3 ± 0.2 cm.
Mean weight: 0.30 ± 0.10 g.
Characteristics: F1 from a single parent-pair bred in UV-treated water.
Reason for selection: this system has been selected as an internationally accepted species.
Total fish used: 26

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Post exposure observation period:

No

Hardness:

250 mg CaCO3 per litre

Test temperature:

20.9- 22.1°C

pH:

6.1 - 6.5

Dissolved oxygen:

Oxygen > 60% of air saturation value

Salinity:

-

Conductivity:

-

Nominal and measured concentrations:

0.1, 1.0, 10 and 100 mg/L (nominal concentrations)

Details on test conditions:

Test vessels: 6.5 litres, all-glass, containing 5 litres of test medium.
Test medium: ISO-medium, aerated until the dissolved oxygen concentration had reached saturation and the pH had stabilised
Number of fish: 7 fish per concentration and control
Loading: 0.39 g fish/litre, i.e. 7 fish per 5 litres of test medium
Illumination: 16 hours photoperiod daily
Aeration: the test media were not aerated during the test
Feeding: no feeding from 48 hours prior to the test and during the total test period
Introduction of fish: within ¾ hour after preparation of the test media
Euthanasia: at the end of the test the surviving fish were rapidly killed by exposing them to ca. 1.2% ethylene glycol monophenylether in water.

Reference substance (positive control):

yes

Remarks:

pentachlorophenol (PCP, concentrations: 0.10, 0.22 and 0.46 mg/L in ISO-medium)

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: LC50 could not be calculated because the test substance proved to be non-toxic

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: No mortality or clinical effects were observed in the limit test.

Details on results:

No LC50 could be calculated because the test substance proved to be non-toxic (LC50 > maximum concentration tested). No mortality or clinical effects were observed during the limit test.

Results with reference substance (positive control):

PCP induced no lethal effects in carp at or below 0.22 mg/L. The 96h-LC50 for carp exposed to PCP was 0.32 mg/L (95 % confidence interval between 0.22 and 0.46 mg/l) and already reached within 24 hours of exposure. The range of the 96hLC50 for carp is generally between 0.10 and 0.46 mg/l based on historical data of reference tests performed approximately every 3 months from April 1988 until the end 2000, and annually since then. The response observed in carp originating from the present batch falls within this range.

Sublethal observations / clinical signs:

- Analysis of the samples taken during the limit test showed that measured concentrations were in agreement with nominal in both the freshly prepared solutions and the 24-hour spent solutions. Recoveries ranged between 87 and 97% of nominal. Hence, further results were based on nominal concentrations.

Validity criteria fulfilled:

yes

Conclusions:

The target substance is expected to have an 96-h LC50 (fish) : > 100 mg/L based on analytically confirmed nominal concentrations.

Executive summary:

The study was conducted on a source substance to determine the short-term toxicity of the test item to fish according to OECD TG 203, EU Method C.1 and ISO 7346 -2 under GLP. Carp (Cyprinus carpio, Teleostei, Cyprinidae) were exposed to the test item at concentrations of: 0 (control), 0.1, 1.0, 10 and 100 mg/L (nominal) for 96 h under static conditions. Samples for analytical confirmation of concentrations were taken from the freshly prepared solutions at the start and after 72 h and from 24 h old solutions after 24h and 96 h of exposure. Mortality and other effects were observed at 2.75, 24, 48, 72 and 96 h following the start of exposure. Analysis of the samples taken during the limit test showed that measured concentrations were in agreement with nominal concentrations in both the freshly prepared solutions and the 24 h old/spent solutions. Recoveries ranged between 87 and 97% of nominal concentrations. Hence, effect levels were estimated based on nominal concentrations. The test item induced no visible effects in Carp at or below 100 mg/L (NOEC). Hence, no LC50 could be calculated (i.e. LC50 greater than maximum concentration tested). The study met the acceptability criteria prescribed by the guidelines. Under the conditions of this study, the 96 h EC50 for common carp (Cyprinus carpio) was considered to be > 100 mg/L nominal and the 96-h NOEC at was 100 mg/L.

For the target substance:

96-h LC50 (fish) : > 100 mg/L based on analytically confirmed nominal concentrations

Reference 3

Endpoint:

short-term toxicity to fish

Type of information:

(Q)SAR

Adequacy of study:

key study

Study period:

2018

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification

Justification for type of information:

1. SOFTWARE
Estimation Programme Interface (EPI) Suite programme for Microsoft Windows v4.11
Contact EPISuite:
U.S. Environmental Protection Agency
1200 Pennsylvania Ave.
N.W. (Mail Code 7406M)
Washington, DC 20460

2. MODEL (incl. version number)
ECOSAR v1.11 - Fish 96h LC50
19 June 2012 (model development)

3. SMILES OR OTHER IDENTIFIERS USED AS INPUT FOR THE MODEL
See attached: ‘Aquatic Toxicity Predictions: Reaction products of 2-hydroxyethyl methacrylate and diphosphorous pentoxide and water’ version 1.0; dated 30 May 2018.

4. SCIENTIFIC VALIDITY OF THE (Q)SAR MODEL
Full details of the method are provided in the attached QMRF named 'QMRF Title: ECOSAR v1.11 Fish 96h LC50’ version 1.1; dated 30 May 2018

5. APPLICABILITY DOMAIN
See ‘any other information on results incl. tables’.
See attached: ‘Aquatic Toxicity Predictions: Reaction products of 2-hydroxyethyl methacrylate and diphosphorous pentoxide and water’ version 1.0; dated 30 May 2018.

6. ADEQUACY OF THE RESULT
1) QSAR model is scientifically valid. 2) The substance falls within the applicability domain of the QSAR model. 3) The prediction is fit for regulatory purpose.
The prediction is adequate for the Classification and Labelling or risk assessment of the substance as indicated in REACH Regulation (EC) 1907/2006: Annex XI Section 1.3. Specifically when combined with further information such as physico-chemistry and environmental fate testing and modelling.

Guideline:

other: REACH Guidance on QSARs R.6, May/July 2008

Guideline:

EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test)

Version / remarks:

This guideline is preferred for the training set but not obligatory

Principles of method if other than guideline:

1. ECOSAR v1.11 - Fish 96h LC50
2. Aquatic Toxicity Assessment of UVCB substances using the Additivity Approach
3. Assessment of Degradability for the purpose of Classification and Labelling

Specific details on test material used for the study:

Detailed information on the 'test material identity' is provided in the attached QSAR Prediction Reporting Format (QPRF) document including information on individual constituents according to point '2. Aquatic Toxicity Assessment of UVCB substances using the Additivity Approach' requirements.

Dose descriptor:

LC50

Effect conc.:

111.7 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: Additive Endpoint Values calculated in line with Block Method Approach

Sublethal observations / clinical signs:

1. Defined Endpoint:

QMRF 3. Ecotoxic effects

QMRF 3.3. Acute Toxicity to Fish (lethality)

Reference to type of model used and description of results:

ECOSAR v1.11 – Fish 96h LC50; 19 June 2012

Note: Effect levels for each trophic group derived from the associated ECOSAR v1.11 model classes above are provided here for completeness.

 

2. Description of results and assessment of reliability of the prediction:

The test item ‘Reaction products of 2-hydroxyethyl methacrylate and diphosphorous pentoxide and water’is a substance of Unknown or Variable composition, Complex reaction products or Biological Materials (UVCB). his complex substance falls under the category of substances difficult to test defined in ECHA Guidance on Information Requirements and Chemical Safety Assessment Chapter R7.b: Endpoint Specific Guidance, Appendix R.7.8-1. As the test item is difficult to test and assessment has been conducted using the block method (reference: Redman et al. PETROTOX: An Aquatic Toxicity Model for Petroleum Substances.: Env, Toxicol. Chem. 31: 2487-2506).

 

1) ECOSAR v1.11 – Fish 96h LC50

2) Aquatic Toxicity Assessment of UVCB substances using the Additivity Approach

Inputs Used for Test Item: All modelling was based on input of SMILES notation for each constituent of the test item and respective hydrolysis products (presented in the attached Aquatic Toxicity Predictions 30-05-2018 QPRF report), meaning that the process relied on modelled values for Kow and water solubility to define the blocks. This approach is in line with the PETROTOX methodology and ECHA Guidance on Information Requirements and Chemical Safety Assessment Chapter R7.b for hazard assessment of complex mixtures.

Table 1. ECOSAR Output for Consolidated Blocks of Test Item Constituents

Block	Block Identifier	Typical Concentration in Test Item (% (w/w))	Log Kow KOWWIN	Water Solubility (mg/L) WSKOWWIN	Daphnid 48 h EC50 (mg/L)	Algae 96 h EC50 (mg/L)	Fish 96 h LC50 (mg/L)
1	Partially soluble – Ester (phosphates)/ Methacrylates	C.B.I.	2.1995	24.73	0.015	0.633	8.029
2	Soluble -Methacrylates	C.B.I.	-1.72 to 1.06	1124 to 1.37 x10^5	202.88	0.951	269.189
3	Soluble – Esters / phosphine oxides	C.B.I.	-0.7699 to 0.6535	11200 to 5.39 x10^5	9.087	213.229	168.576

Note: Concentration in the test item contributing to the additive endpoint values are presented in the attached Aquatic Toxicity Predictions 30-05-2018 QPRF report.

 

For the purpose of concluding on classification and labelling for this substance the additivity formula from Annex I, Section 4.1.3.5.2 of CLP Regulation (EC) 1272/2008 is applied to data on the known components of the substance. The effect values for the test item for each relevant trophic group are presented in the following table.

 

Table 2. Additive Endpoint Values for the Test Item for each Trophic Group

Trophic Level	Endpoint	Endpoint Value (mg/L)
Daphnid	48 h EC50	0.37
Algae	96 h EC50	1.1
Fish	96h LC50	111.7

 

Substance rapidly degradable: YES (OECD TG 301B, 2018)

Log Kow < 4.0: YES. (Block Method, KOWWIN v1.68, US EPA, 2018

 

3) Assessment of Degradability for the purpose of Classification and Labelling

The following data are considered for conclusion on classification and labelling of the test item:

Aquatic toxicity data availability:             Acute

96 h EC50 for Daphnia:                                0.37 mg/L

Substance rapidly degradable:                  YES

Log Kow:                                                             < 4

 

Based on the above considerations, the substance is precautionarily classified as hazardous to the environment under CLP Regulation (EC) 1272/2008: Acute Category 1: H410 - H410: Very toxic to aquatic life with long lasting effects. It must be emphasised by applicant assessment, that it is considered to be a very precautionary classification as comparable UVCB test items, have in experimental testing demonstrated E(L)C50 of > 100 mg/L in relevant testing in Daphnia, Algae and Fish (ECHA, 2018). Further evidence, generated at a later date may confirm the suggestion that no classification and labelling is warranted. For example: at REACH Regulation (EC) 1907/2006: Annex VIII information requirements.

 

Assessment of the substance within the applicability domain as documented within the corresponding QMRF named ‘QMRF named 'QMRF Title: ECOSAR v1.11 Fish 96h LC50’ version 1.1; updated 30 May 2018 – section 5;indicates the substance:

(i) Falls within the Log Kow domain of < 5 (general domain for the model; and relevant chemical classes specific cut off);

(ii) Molecular weights of all constituents are < 1000 g/mol and;

(iii) Effect levels are predicted below the water solubility.

 

The ECOSAR QSAR model as detailed is not known to function by specific modes of action associated with the chemical class(es) assigned. Full references to training set data are presented within ECOSAR v1.1 Help System; if not proprietary (in such cases the chemical identification is listed as CBI, but the relevant descriptor data are provided). A summary of this information is presented by the applicant. The substances in the training set are considered analogues to the target substance since they possess relevant chemical groups and log Kow < 5 and MW < 1000 g/mol. The substance and the structural analogues share a common functional group and physico-chemical domains versus a neutral organics class (baseline toxicity). The ECOSAR class is based on similar relationships between toxicity and the various types of pharmacologic properties.

 

3. Uncertainty of the prediction and mechanistic domain:

No external validation set is available for the chemical class used in this prediction.

Consistency of ECOSAR data compared to measured toxicity showed 60-64 % of green algae predictions (all chemical classes assessed) within a tolerance factor of 10, which is comparable to that seen in Hulzebos & Posthumus (2003).

Uncertainty in the prediction relates to:

Limited external validation on the relevant chemical classes Model predictivity could be improved by the assignment of additional chemical categories and expansion of sub-structure rules, in addition further substances addition to the training set and rules for stereochemical effects within the model would improve predictivity. The ECOSAR QSAR model as detailed is not known to function by specific modes of action associated with the chemical class(es) assigned. ECOSAR classes are grouped based on similar relationships between toxicity and the various types of pharmacologic properties. The model does not apply a mechanistic approach to assessment of toxicity other than assignment of chemical classes (to identify potential toxicity in excess of baseline narcosis) using an expert decision tree. 

Validity criteria fulfilled:

yes

Conclusions:

The results are adequate for the for the regulatory purpose.

Executive summary:

ECOSAR v1.11 – Fish 96h LC50 ; 19 June 2012

Additive endpoint values: Fish 96-hr LC50 111.7 mg/L

 

Adequacy of the QSAR:

1) QSAR model is scientifically valid. 2) The substance falls within the applicability domain of the QSAR model. 3) The prediction is fit for regulatory purpose.

The prediction is adequate for the Classification and Labelling or risk assessment of the substance as indicated in REACH Regulation (EC) 1907/2006: Annex XI Section 1.3.

Description of key information

96-h LC50 (fish) : target : Reaction products of 2-hydroxyethyl methacrylate and diphosphorous pentoxide and water : > 100 mg/L based on analytically confirmed nominal concentrations, freshwater, OECD TG 203, 2021

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

 

Supporting previous information:

QSAR: Fish LC50-96h = 111.7 mg/L (additive endpoint values), ECOSAR v1.11, US EPA, 2018

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L

Additional information

Key data : OECD TG 203, 2004 : Read-Across SOURCE ( Reaction products of 2-hydroxyethyl methacrylate and diphosphorus pentaoxide ): The study was conducted to determine the short-term toxicity of the test item to fish according to OECD TG 203, EU Method C.1 and ISO 7346 -2 under GLP. Carp (Cyprinus carpio, Teleostei, Cyprinidae) were exposed to the test item at concentrations of: 0 (control), 0.1, 1.0, 10 and 100 mg/L (nominal) for 96 h under static conditions. Samples for analytical confirmation of concentrations were taken from the freshly prepared solutions at the start and after 72 h and from 24 h old solutions after 24h and 96 h of exposure. Mortality and other effects were observed at 2.75, 24, 48, 72 and 96 h following the start of exposure. Analysis of the samples taken during the limit test showed that measured concentrations were in agreement with nominal concentrations in both the freshly prepared solutions and the 24 h old/spent solutions. Recoveries ranged between 87 and 97% of nominal concentrations. Hence, effect levels were estimated based on nominal concentrations. The test item induced no visible effects in Carp at or below 100 mg/L (NOEC). Hence, no LC50 could be calculated (i.e. LC50 greater than maximum concentration tested). The study met the acceptability criteria prescribed by the guidelines. Under the conditions of this study, the 96 h EC50 for common carp (Cyprinus carpio) was considered to be > 100 mg/L nominal and the 96 h NOEC at was 100 mg/L.

 

Supporting previous information:

QSAR: Fish LC50-96h = 111.7 mg/L (additive endpoint values), ECOSAR v1.11, US EPA, 2018