Registration Dossier
Registration Dossier
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Diss Factsheets
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EC number: 484-040-8 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Short-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Study period:
- 29 August to 15 September 2011
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
- Remarks:
- This study was performed according to OECD Guideline 202 with GLP certificate. All validity criteria were fulfilled and the substance is considered to be adequately identified. However, this study is not reliable due to high concentration of solvent used. Indeed, a large quantity of acetone was used as solvent in this study. Because of the potential for interaction with the test chemical resulting in an altered response in the test, solvent use should be restricted to situations where no other acceptable method of test solution preparation is available. The use of solvent is not the best method in the case of moderately soluble substances such as this one. Considering the acceptably high water solubility of the substance (44.4 mg/L) and the concentrations used in this study, this method could have been avoided. Furthermore, solvents are generally not appropriate for multiconstituent substances, like the test substance (which is a mixture of isomers), where the use of the solvent can give preferential dissolution of one or more components and thereby affect the toxicity. Then, the concentration/quantity of solvent used in the treatment solutions was 5 mL/L , corresponding to 3.95 g/L (with a density of 0.79), which is 50 times higher than the recommended maximum level of solvent (below 0.1 mL/L; OECD No. 23) and represent almost half of the EC50 of acetone (which was reported in the ECHA disseminated dossier at 8.8 g/L). Acetone is suspected to have affected the definitive results. Some solvent/substance interactions may have occurred in this study with this high concentration of acetone.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 11 March 2011
- Specific details on test material used for the study:
- - Physical state: Light yellow translucent liquid
- Storage condition of test material: Stored at room temperature, protected from direct sun light - Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: Analytical verification of the test item was performed at the concentrations of 0.78, 1.16, 1.75, 2.52 and 3.88 mg/L
- Vehicle:
- yes
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Stock solutions of the test item were prepared in acetone. 50 µL aliquot samples of the stock solutions were used for the treatment application. See Table 6.1.3/1 for further details.
- Controls:
Water control: The control tubes consisted of 10 mL of M4 mineral medium.
Solvent control: The tubes received the same volume of acetone as used for the test item treatments. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Source: Strain was received from a commercial breeder. Organisms were regularly sub-cultured at the Phytosafe site and fed with living cells of the green algae.
- Age: Less than 24 hours at test initiation
- Feeding during test: Daphnids was not fed during the exposure period. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Post exposure observation period:
- None
- Hardness:
- No data
- Test temperature:
- 20 ± 1 °C
- pH:
- Start of the test: 8.2-8.4
End of the test: 7.6-7.8 - Dissolved oxygen:
- Start of the test: 7.7 dissolved O2 mg/L
End of the test: 7.1-7.6 dissolved O2 mg/L - Salinity:
- None
- Conductivity:
- No data
- Nominal and measured concentrations:
- Nominal concentrations: 0.78, 1.16, 1.75, 2.52 and 3.88 mg/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel: 15 mL capacity glass tubes filled with 10 mL of M4 mineral medium.
- Type: The tubes were tightly capped during the exposure period.
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: The M4 mineral medium was freshly reconstituted from mineral stock solutions.
OTHER TEST CONDITIONS
- Photoperiod: The tubes were maintained in the dark in a climatic chamber.
EFFECT PARAMETERS MEASURED
- Immobilization: Each test tube was checked for immobilized daphnids 24 and 48 hours after the start of the test. Any abnormal behavior or appearance, if any, was reported.
- Water quality: Dissolved oxygen and pH were measured at the start and end of the test in the controls and in the highest test substance concentration, at least (definitive test only).
VEHICLE CONTROL PERFORMED: Yes
RANGE-FINDING STUDY
- One replicate unit for each the five test item treatments and for the control.
- Test concentrations: 0.01, 0.1, 1.0, 9.8 and 97.9 mg/L
- Results used to determine the conditions for the definitive study: No immobilization was observed in the controls and the test item treatments up to and including 0.1 mg/L. The percentage of immobilization was 20% for the 1.0 mg/L test item treatment, and 100% for both the 9.8 and the 97.9 mg/L test item treatments. Based on the results, concentrations of 0.78, 1.16, 1.75, 2.52 and 3.88 mg/L were selected for definitive test. - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate at 0.6, 1.0 and 1.7 mg/L
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- 1.58 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: 95% confidence intervals: 1.33 - 1.87 mg/L
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 1.18 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: 95% confidence intervals: 0.97 - 1.44 mg/L
- Duration:
- 24 h
- Dose descriptor:
- other: The highest tested concentration without observed effect
- Effect conc.:
- 0.78 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- other: The highest tested concentration without observed effect
- Effect conc.:
- 0.78 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- Percentage of immobilization:
No immobilization was observed for the water controls over the test period. For the solvent control, mean value for immobilization was 5.0%.
The percentage of immobilization was 20% as a maximum for the 0.78 mg/L test item treatment. Mean final value for the group was 5.0 %.
All the daphnids were immobilized after 24 h of testing for both the 2.52 and 3.88 mg/L test item treatments.
Water quality:
Both the pH values and the oxygen concentrations for the test item treatments were similar to those measured in the controls. In every case the pH value of the mineral medium was between 7.5 and 8.5, and the oxygen concentration remained > 3 mg/L. - Results with reference substance (positive control):
- EC50-24 h for Potassium dichromate was between 0.6 and 1.7 mg/L. The results fulfilled the validity criteria based on Phytosafe historical data: the EC50-24 for Potassium dichromate should be between 0.6 and 1.7 mg/L.
- Reported statistics and error estimates:
- EC50 calculations: After 24 hours of exposure, the regression curve was measured for the three intermediate values of the test item treatments. Both the lowest and the highest test item treatments were excluded because of the plateau-phase. After 48 hours of exposure, the two highest test item treatments were excluded.
- Validity criteria fulfilled:
- yes
- Conclusions:
- Under the test conditions, the 48-hour EC50 of the test item was calculated to be 1.18 mg/L (95% Cl: 0.97-1.44 mg/L) based on analytically confirmed nominal concentrations.
However, this study is not reliable due to high concentration of solvent used. - Executive summary:
A Study was performed according to OECD Guideline 202 with GLP statement, to assess the 48 h-acute toxicity of the of the test item to Daphnia magna.
Test item was exposed to daphnids at the concentrations of 0.78, 1.16, 1.75, 2.52 and 3.88 mg/L for 48 hours. Water and solvent controls were included. There were four replicates per treatment with five daphnids per replicate, which provided a total of twenty daphnids per each treatment and control group at test initiation. The test temperature was 20 ± 1 °C. Before definitive test, a 48-hour range-finding test was conducted and the percent immobilization was 0, 0, 0, 0, 20, 100 and 100% at 0.01, 0.1, 1.0, 9.8 and 97.9 mg/L, respectively.
The analytical verification results showed that the measured concentrations were satisfactorily maintained between 80-120 % of the nominal values throughout the test period. Recovery of the test item at the end of test was 92-96%.
No immobilization was observed for the water controls over the test period. For the solvent control, mean value for immobilization was 5.0%. The percentage of immobilization was 20% as a maximum for the 0.78 mg/L test item treatment. Mean final value for the group was 5.0 %. All the daphnids were immobilized after 24 h of testing for both the 2.52 and 3.88 mg/L test item treatments.
EC50-24 h for Potassium dichromate was between 0.6 and 1.7 mg/L. The results fulfilled the validity criteria based on the historical data.
Under the test conditions, the 48-hour EC50 of the test item was calculated to be 1.18 mg/L (95% Cl: 0.97-1.44) based on analytically confirmed nominal concentrations.
This study is not reliable due to high concentration of solvent used. Indeed, a large quantity of acetone was used as solvent in this study. Because of the potential for interaction with the test chemical resulting in an altered response in the test, solvent use should be restricted to situations where no other acceptable method of test solution preparation is available. The use of solvent is not the best method in the case of moderately soluble substances such as this one. Considering the acceptably high water solubility of the substance (44.4 mg/L) and the concentrations used in this study, this method could have been avoided. Furthermore, solvents are generally not appropriate for multiconstituent substances, like the test substance (which is a mixture of isomers), where the use of the solvent can give preferential dissolution of one or more components and thereby affect the toxicity. Then, the concentration/quantity of solvent used in the treatment solutions was 5 mL/L , corresponding to 3.95 g/L (with a density of 0.79), which is 50 times higher than the recommended maximum level of solvent (below 0.1 mL/L; OECD No. 23) and represent almost half of the EC50 of acetone (which was reported in the ECHA disseminated dossier at 8.8 g/L). Acetone is suspected to have affected the definitive results. Some solvent/substance interactions may have occurred in this study with this high concentration of acetone.
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- (Q)SAR
- Adequacy of study:
- key study
- Study period:
- July 31st, 2019
- Reliability:
- 1 (reliable without restriction)
- 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
iSafeRat® toolbox – in Silico Algorithms For Environmental Risk And Toxicity version 2.4
2. MODEL (incl. version number)
iSafeRat® holistic HA-QSAR v1.8
3. SMILES OR OTHER IDENTIFIERS USED AS INPUT FOR THE MODEL
isomer 1: CC1=CCC(CC2CC(CCO2)=C)C(C)1C
isomer 2: CC1=CCC(CC2C=C(C)CCO2)C(C)1C
isomer 3: CC1=CCC(CC2CC(C)=CCO2)C(C)1C
4. SCIENTIFIC VALIDITY OF THE (Q)SAR MODEL
See attached QMRF
5. APPLICABILITY DOMAIN
See attached QPRF
6. ADEQUACY OF THE RESULT
See attached QPRF - Reason / purpose for cross-reference:
- reference to other study
- Remarks:
- QSAR input value
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- yes
- Remarks:
- QSAR model
- Principles of method if other than guideline:
- The purpose of this QSAR model is to accurately predict the acute toxicity to daphnids as would be expected in a laboratory experiment following OECD Guideline 202 (OECD, 2004b) and EC method C.2 (European Commission, 2008) for specific, named mechanisms of action. The model provides an in silico prediction for the 48-hour EC50 value that can effectively be used in place of an experimentally derived 48-hour EC50 value. The regression based method used to achieve this has been fully validated following the OECD recommendations (OECD, 2004a).
- GLP compliance:
- no
- Remarks:
- QSAR model
- Specific details on test material used for the study:
- - Water solubility: 44,4 mg/L at 25°C (KREATiS, 2019)
- Analytical monitoring:
- no
- Remarks:
- QSAR model
- Details on sampling:
- not applicable
- Vehicle:
- no
- Remarks:
- QSAR model
- Details on test solutions:
- not applicable
- Test organisms (species):
- other: Daphnia magna, Daphnia pulex
- Details on test organisms:
- No difference in terms of toxic mechanism of action between invertebrate (or indeed other) aquatic species is expected. Any observed differences may be attributed to lifestyle related parameters (e.g. shell closing in molluscs) and relative duration of study versus bodysize rather than to a specific toxic mechanism causing species differences.
- Test type:
- other: QSAR model
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Remarks on exposure duration:
- Results from a test duration of 48 hours only were used for daphnid species.
- Post exposure observation period:
- None
- Hardness:
- The QSAR is based on data from studies performed at acceptable hardness to ensure control survival.
- Test temperature:
- The temperatures varied from approximately 20 to 23 °C depending on the species used to construct the algorithm. This small difference is not expected to contribute to the variability of the EC50 values found in experimental data.
- pH:
- Test results were taken from studies with measured pHs between 6 - 9.
- Dissolved oxygen:
- The QSAR is based on data from studies performed at acceptable oxygen concentrations (generally >60%).
- Salinity:
- Not applicable
- Conductivity:
- Not data
- Nominal and measured concentrations:
- Studies were used only where sufficient evidence was presented to determine that the substance was stable under test conditions (i.e. maintained within ± 20 % of the nominal) or, if not, the result was based on measured concentrations as geometric mean.
- Details on test conditions:
- Preferentially results from semi-static studies were used. However, substances tested using a static design were accepted (preferably accompanied by analytical measurements over the study period). For suspected volatile substances only tests performed in closed vessels were accepted unless accompanying analytical monitoring proved such a design was not necessary.
- Reference substance (positive control):
- no
- Remarks:
- QSAR model
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 3.3 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: 95%CI: 0.9 – 3.7 mg/L.
- Details on results:
- The test item falls within the applicability domain of the model and was therefore reliably predicted for its acute toxicity (48h-EC50) to daphnids. Therefore, this endpoint value can be considered valid for use in risk assessment and classification and labelling.
- Results with reference substance (positive control):
- not applicable
- Reported statistics and error estimates:
- 95% confidence interval (α = 0.05): 2.9 – 3.7 mg/L.
QSAR statistical parameters are given in the QMRF and the QPRF - Validity criteria fulfilled:
- yes
- Conclusions:
- The test item falls within the applicability domain of the model and was therefore reliably predicted for its acute toxicity (48h-EC50) to daphnids. Therefore, this endpoint value can be considered valid for use in risk assessment and classification and labelling.
The 48h-EC50 of the test item to daphnids was predicted as 3.3 mg/L.
95% confidence interval (α = 0.05): 2.9 – 3.7 mg/L. - Executive summary:
A Quantitative Structure-Activity Relationship (QSAR) model was used to calculate the acute toxicity of the test item to daphnid. This QSAR model has been validated to be compliant with the OECD recommendations for QSAR modeling (OECD, 2004a) and predicts the endpoint value which would be expected when testing the substance under experimental conditions in a laboratory following the Guideline for Testing of Chemicals No. 202, "Daphnia sp., Acute Immobilisation Test" (OECD, 2004b), referenced as Method C.2 of Commission Regulation No. 440/2008 (European Commission, 2008). The criterion predicted was the EC50 (Median Effective Concentration), a statistically derived concentration which is expected to cause immobility in 50% of test animals within a period of 48 hours.
The immobility of the daphnids was determined using a validated QSAR model for the Mechanism of Action (MechoA) in question (MechoA 1.1, i.e. non-polar narcosis) (Bauer et al., 2018). The QSAR model is based on validated data for a training set of 58 chemicals derived from 48-hour test on daphnids, for which the concentrations of the test item had been determined by chemical analyses over the test period.
The test item falls within the applicability domain of the model and was therefore reliably predicted for its acute toxicity (48h-EC50) to daphnids. Therefore, this endpoint value can be considered valid for use in risk assessment and classification and labelling.
The 48h-EC50 of the test item to daphnids was predicted as 3.3 mg/L.
95% confidence interval (α = 0.05): 2.9 – 3.7 mg/L.
Referenceopen allclose all
Analytical verification of the test item treatments:
The results showed that the measured concentrations were satisfactorily maintained between 80-120 % of the nominal values throughout the test period.
Table 6.1.3/2: Measured concentrations of the test substance as % of the nominal values
Test item - Nominal values |
Initial medium |
Final medium |
0.78 mg/L |
105.1% |
102.4% |
1.16 mg/L |
102.4% |
98.9% |
1.75 mg/L |
101.4% |
97.1% |
2.52 mg/L |
102.0% |
98.0% |
3.88 mg/L |
100.3% |
96.8% |
Table 6.1.3/3: Definitive test - Percentages of immobilized daphnids for the controls and the test item treatments
Groups |
% immobilization after 24 h |
% immobilization after 48 h |
||||||
Rep 1 |
Rep 2 |
Rep 3 |
Rep 4 |
Rep 1 |
Rep 2 |
Rep 3 |
Rep 4 |
|
Water control |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Solvent control |
0 |
0 |
0 |
0 |
0 |
0 |
20 |
0 |
Test item |
||||||||
0.78 mg/L |
0 |
20 |
0 |
0 |
0 |
20 |
0 |
0 |
1.16 mg/L |
0 |
20 |
20 |
20 |
40 |
40 |
60 |
40 |
1.75 mg/L |
60 |
60 |
80 |
60 |
100 |
100 |
100 |
80 |
2.52 mg/L |
100 |
100 |
100 |
100 |
100 |
100 |
100 |
100 |
3.88 mg/L |
100 |
100 |
100 |
100 |
100 |
100 |
100 |
100 |
VALIDITY OF THE TEST RESULTS
The tests were considered as valid:
Immobilization was less than 10 % in the controls,
The dissolved oxygen concentration exceeded 3 mg/L in the controls and every test item treatment.
Analysis of the Applicability Domain
Descriptor domain
The Subcooled Liquid Water Solubility value (44.4 mg/L or -3.696 in log (mol/L)) given as the input to the Ecotox module of the iSafeRat® Holistic HA-QSAR falls within the descriptor domain of the model between a log water solubility (in log (mol/L)) of - 4.70 to 0.87.
Structural fragment domain
All chemical groups within the molecular structure are taken into account by the model.
Mechanistic domain
Currently, the ecotoxicity module of the iSafeRat® Holistic HA-QSAR can reliably predict the aquatic toxicity for chemicals with the following mechanisms of action of toxicity (MechoA):
• non-polar narcosis (MechoA 1.1)
• polar narcosis of alkyl-/alkoxy-phenols (MechoA 1.2)
• polar narcosis of aliphatic amines (MechoA 1.2)
• cationic narcosis of quaternary ammoniums (MechoA 1.3)
• mono-/poly-esters whose hydrolysis products are narcotics (MechoA 2.1)
• hard electrophile reactivity (MechoA 3.1)
• RedOx cycling of primary thiols (MechoA 4.4)
• Proton release of carboxylic acids (MechoA 5.2)
The MechoA of molecules is predicted directly from the structure. The test item as an aliphatic ether is expected to exert a MechoA 1.1 and can be taken into account by the model.
Description of key information
iSafeRat® High-Accuracy-Quantitative Structure-Activity Relationship, KREATIS, 2019 :
48h-EC50 = 3.3 mg/L (95% confidence interval: 2.9 – 3.7 mg/L)
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 3.3 mg/L
Additional information
One experimental study and one QSAR prediction are available to assess the short-term toxicity of the registered substance to aquatic invertebrates.
The experimental study (Phytosafe, 2011) was considered as not reliable and was disregarded due to major methodological deficiencies. Indeed, a large quantity of acetone was used as solvent in this study. Because of the potential for interaction with the test chemical resulting in an altered response in the test, solvent use should be restricted to situations where no other acceptable method of test solution preparation is available. The use of solvent is not the best method in the case of moderately soluble substances such as this one. Considering the acceptably high water solubility of the substance (44.4 mg/L) and the concentrations used in this study, this method could have been avoided. Furthermore, solvents are generally not appropriate for multiconstituent substances, like the test substance (which is a mixture of isomers), where the use of the solvent can give preferential dissolution of one or more components and thereby affect the toxicity. Then, the concentration/quantity of solvent used in the treatment solutions was 5 mL/L , corresponding to 3.95 g/L (with a density of 0.79), which is 50 times higher than the recommended maximum level of solvent (below 0.1 mL/L; OECD No. 23) and represent almost half of the EC50 of acetone (which was reported in the ECHA disseminated dossier at 8.8 g/L). Therefore, solvent/substance interactions may have occured in this study with this high concentration of acetone and the result cannot be considered fit for use.
The QSAR prediction (KREATiS, 2019) was considered as reliable. The QSAR model has been validated to be compliant with the OECD recommendations for QSAR modeling (OECD, 2004) and predicts the endpoint value which would be expected when testing the substance under experimental conditions in a laboratory following the OECD Guideline 202. The immobility of the daphnids was determined using a validated QSAR model for the Mechanism of Action (MechoA) in question (MechoA 1.1, i.e.non-polar narcosis) (Baueret al.,2018). The QSAR model is based on validated data for a training set of 58 chemicals derived from 48-hour test on daphnids, for which the concentrations of the test item had been determined by chemical analyses over the test period. The test item falls within the applicability domain of the model and was therefore reliably predicted for its acute toxicity (48h-EC50) to daphnids. Therefore, this endpoint value can be considered valid for use in risk assessment and classification and labelling.
The 48h-EC50 of the test item to daphnids was predicted as 3.3 mg/L (95% CI: 2.9 - 3.7 mg/L).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.