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EC number: 807-715-4 | CAS number: 1354569-12-2
- 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
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2013
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP screening test, no analytical verification of test concentrations; very poorly soluble substance.
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- yes
- Remarks:
- the concentrations were not analytically verified and statistics not performed
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Deviations:
- yes
- Remarks:
- the concentrations were not analytically verified and statistics not performed
- Principles of method if other than guideline:
- Acute toxicity of bis(2-ethylhexyl)citraconate was assessed with acute immobilisation test on Daphnia Magna, over an exposure period of 48 hours in a semi-static system. Four test concentrations in a geometric series with a separation factor of 10 an one treated control were tested in the experiment. The nominal concentrations of test item used in the experiment were 0.1; 1; 10 and 100 mg/L. Ten animals, divided into two groups (glass beaker) of five animals each were used at the test concentrations and at the control groups.
- GLP compliance:
- no
Test material
- Reference substance name:
- 1,4-bis(2-ethylhexyl) (2Z)-2-methylbut-2-enedioate
- EC Number:
- 807-715-4
- Cas Number:
- 1354569-12-2
- Molecular formula:
- C21 H38 O4
- IUPAC Name:
- 1,4-bis(2-ethylhexyl) (2Z)-2-methylbut-2-enedioate
- Reference substance name:
- di(2-ethylhexyl) (2Z)-2-methyl-2-butenedioate
- IUPAC Name:
- di(2-ethylhexyl) (2Z)-2-methyl-2-butenedioate
- Test material form:
- other: liquid
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- Details on properties of test surrogate or analogue material (migrated information):
Batch B018-000-00001
Sampling and analysis
- Analytical monitoring:
- no
Test solutions
- Details on test solutions:
- According to the OECD Guidance Document 23 (Aquatic Toxicity Testing of Difficult Substances and Mixtures), supersaturated test item solution (nominal loading rate of 100 mg/L) was prepared by dispersing/dissolving the appropriate amount of test item into the test medium (ISO medium) two days before the start of the experiment. The solution was shaken for about 24 hours at approx. 30 oC and then equilibriated for about 24 hours at approx. 20 oC. The non-dissolved test material was removed by filtration frough a fine (0.22 µm) filter to give the 100 % saturated solution.
During the formulation procedure the nominal test solution 10 mg/L was prepared by the method described above. Nominal test concentrations of 1 mg/L and 0.1 mg/L were prepared by appropriate dilution of nominal test concentrations of 10 mg/L and 1 mg/L respectively.
The test solutions were distributed into the appropriate beckers.
The test was performed under semi-static conditions. The frequency of the reconstituted water renewal period was 24 hours. Prior to treatment of each renewal period the test item solutions were prepared by the method described above.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Esperimental animals were provided by National Institute of Public Health, 1097 Budapest Gyali u. 2 - 6, Hungary.
They were less than 24 h old at the beginning of the test. No acclimatization as the water used was similar to culture water.
10 animals in test and control groups, dived into 2 replicates (5 animals/replicate).
Study design
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
Test conditions
- Hardness:
- The reconstituted water (ISO medium) had an approx. Theoretical total hardness of 249 mg/L (as CaCO3).
- Test temperature:
- 20.0 - 20.3 oC measured in the test vessels (daily, old and fresh media where possible). Additionally, climate chamber temperature was between 19.8 and 20.2 oC.
- pH:
- In the range of 7.68 - 7.96 (measured in each vessel daily, old and fresh media where possible). Not adjusted, not varied by more than 1.5 units in any one test.
- Dissolved oxygen:
- In the range of 7.48 - 8.54 mg/L (measured in each vessel daily, old and fresh media where possible).
- Nominal and measured concentrations:
- Only nominal concentrations were applied, as described above.
- Details on test conditions:
- The test was carried out in 16-h light and 8-hour dark cycle.
For untreated controls, dilution water (ISO medium) was used without addition of the test item (Appendix 3 of the test report as attachment 1) - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate, batch 0769128
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 other: % saturated solution
- Nominal / measured:
- nominal
- Conc. based on:
- dissolved
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 other: % of saturated solution
- Nominal / measured:
- nominal
- Conc. based on:
- dissolved
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- > 100 other: % saturated solution
- Nominal / measured:
- nominal
- Conc. based on:
- dissolved
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- LOEC
- Effect conc.:
- > 100 other: % saturated solution
- Nominal / measured:
- nominal
- Conc. based on:
- dissolved
- Basis for effect:
- mobility
- Details on results:
- Based on the results of this study, the test item bis (2-ethylhexyl)citraconate had no toxic effect at saturation on Daphnia. The EC50 results and the LOEC are higher than the solubility level of the test item in the test medium.
Details of the test conditions data are available in Appendix 1 of the test report (attachment 2). - Results with reference substance (positive control):
- Reference control: 24-h EC50 was 0.82 mg/L (95 % confidence limits 0.76 . 0.87 mg/L).
- Reported statistics and error estimates:
- No statistical analysis was performed because of the lack of toxic effects. The EC50, NOEC, LOEC and EC100 were determined directly from th rae data.
Any other information on results incl. tables
Table.1 Number and percentage of immobilised animals.
Nominal (mg/L) | Number of | Number (percent) of immobilised animals | ||||
preparation | treated animals | 24 h | 48 h | |||
Control | 10 | 0 (0) | 0 (0) | |||
0.1 | 10 | 0 (0) | 0 (0) | |||
1 | 10 | 0 (0) | 0 (0) | |||
10 | 10 | 0 (0) | 0 (0) | |||
100 | 10 | 0 (0) | 0 (0) |
Data of immobility in each test vessel are detailed in Appendix 2 of the test report (attachment 3).
Applicant's summary and conclusion
- Validity criteria fulfilled:
- no
- Remarks:
- The nominal concentrations o.1, 1 10 and 100 mg/L were prepared but not verified analytically. The substance is very poorly soluble in water.
- Conclusions:
- The acute aquatic toxicity (EC50 48-h) to daphinds was > 100% of the saturated solution. (The nominal concentrations were 0.1, 1, 10 and 100 mg/L at 20 oC; the substance is very poorly soluble in water.)
- Executive summary:
The acute aquatic toxicity (EC50 48-h) to daphinds was > 100% of the saturated solution in a non-GLP screening test (OECD 202). The nominal concentrations were 0.1, 1, 10 and 100 mg/L at 20 oC. Concentrations were not analytically measured and the substance is very poorly soluble in water. The results are therefore rated as reliable with restrictions (Klimisch 2).
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