Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 807-422-1 | CAS number: 66918-01-2
- 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:
- key study
- Study period:
- 2015-08-06 to 2015-10-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and appropriate guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 850.1010 (Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF (12-Nousan-No.8147,2-7-2-1,24 November, 2000)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1,4-bis[2-(4,4-dimethylpentan-2-yl)-5,7,7-trimethyloctyl] 2-hydroxybutanedioate
- EC Number:
- 807-422-1
- Cas Number:
- 66918-01-2
- Molecular formula:
- C40H78O5
- IUPAC Name:
- 1,4-bis[2-(4,4-dimethylpentan-2-yl)-5,7,7-trimethyloctyl] 2-hydroxybutanedioate
Constituent 1
Sampling and analysis
- Analytical monitoring:
- not specified
Test solutions
- Vehicle:
- yes
- Details on test solutions:
- Reconstituted water (ISO medium, according to OECD 202) was used as dilution water for both the range-finding and definitive tests. The same composition of reconstituted water was used for the tests and for breeding the test animals.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Breeding The Daphnia are bred in Ecotoxicological TEST Laboratory.
The health of the stock animals is continuously monitored by visual daily checking. Abnormal behavior or significant decrease of population is recorded.
Justification of strain: Daphnia magna is the standard species of the acute immobilisation test.
Number of animals: There were 20 animals in test group and control group respectively, divided into 4 replicates (5 animals / replicate)
Age of the animals: They were less than 24 h old at the beginning of the test
Acclimatization: There was no acclimatization because the water used was similar to the culture water.
Study design
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
- Post exposure observation period:
- The immobility or mortality of the Daphnia was determined by visual observation 24 and 48 hours after the start of the test. Those animals not able to swim within 15 seconds after gentle agitation of the test beaker are considered to be immobile.
The number of immobilised animals and the percentage of immobility were determined at 24 and 48 hours.
The water temperature, oxygen concentrations and pH of the control and the test solution were measured at the beginning and at the end of the renewal periods.
Test conditions
- Hardness:
- The reconstituted water (ISO medium) had a total hardness of 246 mg/L (as CaCO3).
- Test temperature:
- Start of test, renewal period and end of test: 20.2 – 20.6°C.
The additionally measured temperature in the climate chamber was between 19.7 and 20.7°C. - pH:
- The pH of the test solution was not adjusted and not varied by more than 1.5 units in any one test.
Start of test, renewal period and end of test: 7.32 – 7.89. - Dissolved oxygen:
- Start of test, renewal period and end of test: 8.2 – 8.4 mg/L.
- Salinity:
- no further details
- Nominal and measured concentrations:
- Because the test item is very poorly soluble in water, a test solution was prepared according to OECD method No. 23.
Nominal concentration: 100 mg/L and non-dissolved test material was removed to obtained a 100% saturated solution. - Details on test conditions:
- According to guidelines
- Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
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:
- test mat.
- Basis for effect:
- mortality
- Remarks:
- and percentage of immobility
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 other: % saturation
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Remarks:
- and percentage of immobility
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 100 other: % saturated solution
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Remarks:
- and percentage of immobility
- Duration:
- 48 h
- Dose descriptor:
- LOEC
- Effect conc.:
- > 100 other: % saturated solution
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Remarks:
- and percentage of immobility
- Duration:
- 48 h
- Dose descriptor:
- EC100
- Effect conc.:
- > 100 other: % saturated solution
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Remarks:
- and percentage of immobility
- Reported statistics and error estimates:
- No statistical analysis was performed because of the lack of toxic effects. The EC50, NOEC, LOEC and EC100 values were determined directly from the raw data.
Any other information on results incl. tables
Number and percentage of immobilised animals
Number of immobilised animals | |||||
Test group | Number of treated animals | 24 hours | 48 hours | ||
number | percent | number | percent | ||
Control | 20 | 0 | 0 | 0 | 0 |
100% saturated solution | 20 | 0 | 0 | 0 | 0 |
In addition to immobility, no abnormal behavior or appearance of test animals was detected.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- Acute toxicity of Bis[2-(4,4-dimethylpentan-2-yl)-5,7,7-trimethyloctyl] malate was assessed with Acute immobilisation test on Daphnia magna, over an exposure period of 48 hours in a semi-static system.
All validity criteria were met during this study.
Under the conditions of this Daphnia magna acute immobilisation study the observed endpoints for the effect of Bis[2-(4,4-dimethylpentan-2-yl)-5,7,7-trimethyloctyl] malate were the followings:
The 24h and 48h EC50 value: > 100 % saturated solution (nominal)
The 48h (NOEC): 100 % saturated solution (nominal)
The 48h (LOEC): > 100 % saturated solution (nominal)
The 48h EC100 value: > 100 % saturated solution (nominal)
Based on the results of this study, the Bis[2-(4,4-dimethylpentan-2-yl)-5,7,7-trimethyloctyl] malate had no toxic effect at saturation; the EC50 results and the LOEC are higher than the solubility level of the test item in the test medium. - Executive summary:
Acute toxicity of Bis[2-(4,4-dimethylpentan-2-yl)-5,7,7-trimethyloctyl] malate on Daphnia magna was assessed in an Acute immobilisation test, over an exposure period of 48 hours in a semi-static test system. Toxic effects were not observed during the preliminary concentration range-finding test therefore a limit test was performed in the main experiment using only one test concentration at the limit of solubility of the test item in the test medium (100 % saturated solution) and one control group.
The experiment was carried out without analytical support based on agreement with the Sponsor.
Twenty animals, divided into four groups (glass beaker) of five animals each were used at the test concentration and for the control.
No statistical analysis was performed because of the lack of toxic effects. The EC50, NOEC, LOEC and EC100values were determined directly from the raw data. All validity criteria were met during this study.
Under the conditions of this Daphnia magna acute immobilisation study the observed endpoints for the effect of Bis[2-(4,4-dimethylpentan-2-yl)-5,7,7-trimethyloctyl] malate were the followings:
The 24h and 48h EC50value: >100 % saturated solution (nominal)
The 48h NOEC: 100 % saturated solution (nominal)
The 48h LOEC: >100 % saturated solution (nominal)
The 48h EC100value: >100 % saturated solution (nominal)
Based on the results of this study, the test item Bis[2-(4,4-dimethylpentan-2-yl)-5,7,7-trimethyloctyl] malate had no toxic effect at saturation; the EC50 results and the LOEC are higher than the solubility level of the test item in the test medium.
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.