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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 700-453-0 | CAS number: 59802-05-0
- 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 fish
Administrative data
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010-02-10 to 2011-03-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- (1992)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Version / remarks:
- Commission Regulation (EC) No. 440/2008
- Deviations:
- no
- Principles of method if other than guideline:
- Pre-study solubility work conducted indicated that the test item was practically insoluble in water using traditional methods of preparation e.g. ultrasonication and high shear mixing. Based on this information the test item was categorised as being a 'difficult substance' as defined by the OECD Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures (OECD 2000). Therefore a media preparation trial was conducted in order to determine the solubility of the test item under test conditions.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1,4-Benzenedicarboxylic acid, 1,4-diisononyl ester
- EC Number:
- 700-453-0
- Cas Number:
- 59802-05-0
- Molecular formula:
- C26H42O4
- IUPAC Name:
- 1,4-Benzenedicarboxylic acid, 1,4-diisononyl ester
- Test material form:
- liquid
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: "Limit test" was conducted at a concentration of 100% v/v saturated solution
- Sampling method: The concentration and stability of the test item in the test preparations were verified by chemical analysis at 0 (fresh media), 24 and 96 hours (old media). Water samples were taken from the control and each replicate test vessel at 0 (fresh media), 24 and 96 hours (old media) for quantitative analysis. Duplicate samples and samples at 24 (fresh media), 48 and 72 hours (fresh and old media) were taken and stored at approximately -20°C for further analysis if necessary.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Pre-study solubility work conducted indicated that the test item was practically insoluble in water using traditional methods of preparation e.g. ultrasonication and high shear mixing. Based on this information the test item was categorised as being a 'difficult substance' as defined by the OECD Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures (OECD 2000). Therefore a media preparation trial was conducted in order to determine the solubility of the test item under test conditions.
An amount of test item (200 mg) was dispensed in duplicate, on to the surface of 2 litres of reconstituted water with the aid of magnetic stirring at a rate such that a dimple was formed at the water surface for periods of 24 or 48 hours. After stirring the aqueous phase was removed from the bottom of the mixing vessel and samples taken for chemical analysis. The pre-study media preparation trials indicated that a saturated solution method of preparation utilising a very slow stir rate was most appropriate for this test item due to its inherent tendency to form micro micelles.
For the definitive test the saturated solution was prepared using a very slow stir method of preparation with a 24 hour stir. An amount of test item (2100 mg) was dispensed on to the surface of 21 litres of dechlorinated tap water prior to stirring slowly via magnetic stirrer for 24 hours. After 24 hours the stirring was stopped and the aqueous phase removed by mid-depth siphoning to give a 100% v/v saturated solution of test item. This method of preparation was conducted in duplicate. The concentration and stability of the test item in the test preparations were verified by chemical analysis at 0 (fresh media), 24 and 96 hours (old media).
- Controls: test medium without test substance. The control group was maintained under identical conditions but not exposed to the test item.
- Vehicle: Auxiliary solvents to aid dissolution were not employed.
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): Microscopic inspection of the saturated solution showed no micro-dispersions or undissolved test item to be present in the range finding test. The test preparations were observed to be clear, colourless solutions throughout the duration of the definitive test.
Test organisms
- Test organisms (species):
- Oncorhynchus mykiss (previous name: Salmo gairdneri)
- Details on test organisms:
- TEST ORGANISM
- Common name: Rainbow trout (Oncorhynchus mykiss)
- Source: Brow Well Fisheries Limited, Hebden, near Skipton, Yorkshire, UK
- Age at study initiation: juvenile
- Length at study initiation: mean standard length of 5.6 em (sd = 0.5)
ACCLIMATION
- Acclimation period: Fish were acclimatised to test conditions for 12 days.
- Acclimation conditions: The lighting cycle was controlled to give a 16 hours light and 8 hours darkness cycle with 20 minute dawn and dusk transition periods.
- Type and amount of food during acclimation: The stock fish were fed commercial trout pellets which was discontinued 24 hours prior to the start of the definitive test.
- Health during acclimation: There was 0% mortality in the 7 days prior to the start of the test.
FEEDING DURING TEST
- The fish received no food during exposure.
Study design
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
Test conditions
- Hardness:
- 140 mg/l as CaC03
- Test temperature:
- 14 °C
- Dissolved oxygen:
- 9.83 mg O2/l
- Nominal and measured concentrations:
- nominal: 100 % (v/v) saturated solution (initnital loading rate 100 mg test substance per litre, slow stir method). The concentration and stability of the test item in the test preparations were verified by chemical analysis at 0 (fresh media), 24 and 96 hours (old media).
- Details on test conditions:
- TEST SYSTEM
- Test vessel: 20 litre glass exposure vessels for each test concentration
- Type: covered to reduce evaporation
- Aeration: aerated via narrow bore glass tubes
- Renewal rate of test solution: daily renewal of the test preparations
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 1
- Biomass loading rate: Loading rate of 0.87 g bodyweight/litre (static volume).
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Laboratory tap water was dechlorinated by passage through an activated carbon filter and partly softened. After dechlorination and softening the water was passed through a series of computer controlled plate heat exchangers to achieve the required temperature.
- Ca/mg ratio: 140 mg/L CaCO3
- Culture medium different from test medium: The test water used for both the range-finding and definitive tests was the same as that used to maintain the stock fish.
OTHER TEST CONDITIONS
-pH: The pH was measured using a Hach hq30d pH.
- Photoperiod: 16 hours light and 8 hours darkness with 20 minute dawn and dusk transition periods for a period of 96 hours
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
TEST CONCENTRATIONS
- Spacing factor for test concentrations: Limit test
- Justification for using less concentrations than requested by guideline: Based on the results of the range-finding test a "Limit test" was conducted at a concentration of 100% v/v saturated solution to confirm that at the highest attainable test concentration, no mortalities or sub-lethal effects of exposure were observed.
- Range finding study
- Test concentrations: In the range-finding test fish were exposed to a single nominal concentration of 100% v/v saturated solution, as the Acute Toxicity to Daphnia magna test indicated that toxicity was not expected at this concentration.
- Results used to determine the conditions for the definitive study: Based on initial preliminary work the test item was prepared as a saturated solution, using a column elution method. The results from the range-finding test for this study showed no effects at 100% v/v saturated solution. The range-finding and definitive tests for the Acute Toxicity to Daphnia magna test showed no toxic effects to exposure using the slow-stirring method of preparation. Therefore, for ethical reasons, it was considered unnecessary to conduct a further range-finding test for this study using the slow-stirring method of preparation given that toxic effects were not expected. Based on the results of the range-finding test a "Limit test" was conducted at a concentration of 100% v/v saturated solution to confirm that at the highest attainable test concentration, no mortalities or sub-lethal effects of exposure were observed. - Reference substance (positive control):
- no
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 2 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 0.007 mg/L
- Duration:
- 6 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 0.007 mg/L
- Duration:
- 24 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 0.007 mg/L
- Duration:
- 48 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 0.007 mg/L
- Key result
- Duration:
- 72 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 0.007 mg/L
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 0.007 mg/L
- Details on results:
- Analysis of the test preparations at 0, 24 and 96 hours showed measured test concentrations to range from 0.00108 to 0.0220 mg/L and so it was considered justifiable to estimate the LC50 values in terms of the nominal test concentrations only.
There were no mortalities in 14 fish exposed to a mean measured test concentration of 0.0066 mg/L for a period of 96 hours. The results of the definitive test showed the highest test concentration resulting in 0% mortality to be greater than or equal to 0.0066 mg/L and the No Observed Effect Concentration (NOEC) to be 0.0066 mg/L. The No Observed Effect Concentration is
based upon zero mortalities and the absence of any sub-lethal effects of exposure at this concentration. There were no sub-lethal effects of exposure observed in the test. The test preparations were observed to be clear, colourless solutions throughout the
duration of the test.
Any other information on results incl. tables
- Sublethal observations / clinical signs:
Cumulative Mortality Data in the Definitive Test
Mean Measured Test Concentration (mg/L)
Cumulative Mortality
(Initial Population=7)
%
Mortality
Control
0
0
0
0
0
0
0
100R1
0
0
0
0
0
0
0
100R2
0
0
0
0
0
0
0
Concentrations in Aqueous Test Media Samples Determined Using HPLC Analysis
Sample
Nominal Concentration
(% v/v Saturated Solution)
Concentration
Found (mg/L)
0 hours
Control
100 R1
100 R2
<LOQ
0.00108
0.00810
24 hours
Control
100 R1
100 R2
<LOQ
0.00114
0.00578
96 hours
Control
<LOQ
0.0220
0.00121
Applicant's summary and conclusion
- Conclusions:
- The acute toxicity of the test item to the freshwater fish rainbow trout (Oncorhynchus mykiss) has been investigated No mortalities were observed within the water solubility limits of the test item. The 96-Hour LC50 is therefore considered to be greater than the maximum achievable water solubility. This corresponds to greater than 0.0066 mg/L based on the mean measured test concentration. The No Observed Effect Concentration was greater than or equal to the water solubility (0.0066 mg/L based on the mean measured test concentration). This study showed that there were no toxic effects at saturation.
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.