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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: - | 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:
- key study
- Study period:
- 2016-01-04 to 2016-02-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Polyadd Limited; Batch no. 0900
- Expiration date of the lot/batch: 2016-10-22
- Purity test date: 2015-10-22
- Purity: 98.8
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature, in the dark
- Stability under test conditions: Not specified
FORM AS APPLIED IN THE TEST (if different from that of starting material): Clear colorless liquid - Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: In the range-finding test Daphnia magna were exposed to a series of nominal test concentrations of 0.10, 1.0, 10 and 100% v/v saturated solution. Based on the results of the range-finding test the following test concentrations were assigned to the definitive test: 10, 18, 32, 56 and 100% v/v saturated solution
- Sampling method:
Range-finding Test:
A nominal amount of test item (550 mg) was dispersed in 11 liters of test water with the aid of propeller stirring at approximately 1500 rpm for 24 hours. After 24 hours the stirring was stopped and any undissolved test item was removed by centrifugation at 40000 g for 30 minutes to give a 100% v/v saturated solution. A series of dilutions was made from this saturated solution to give further test concentrations of 0.10, 1.0 and 10% v/v saturated solution. Each prepared concentration was inverted several times to ensure adequate mixing and homogeneity.
Definitive Test:
A nominal amount of test item (550 mg) was dispersed in 11 liters of test water with the aid of propeller stirring at approximately 1500 rpm for 24 hours. After 24 hours the stirring was stopped and any undissolved test item was removed by centrifugation at 40000 g for 30 minutes to give a 100% v/v saturated solution. A series of dilutions was made from this saturated solution to give further test concentrations of 10, 18, 32 and 56% v/v saturated solution. Each prepared concentration was inverted several times to ensure adequate mixing and homogeneity.
- Sample storage conditions before analysis: A sample of each test concentration was taken for chemical analysis at 0 and 48 hours in order to determine the stability of the test item under test conditions. All samples were stored frozen prior to analysis - Vehicle:
- yes
- Remarks:
- Reconstituted water (ISO medium)
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
Preliminary 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 categorized 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.
Range-finding Test
The results obtained from the preliminary media preparation trial conducted indicated that a dissolved test item concentration of approximately 5.2 mg/L could be obtained using a saturated solution method of preparation.
A nominal amount of test item (550 mg) was dispersed in 11 liters of test water with the aid of propeller stirring at approximately 1500 rpm for 24 hours. After 24 hours the stirring was stopped and any undissolved test item was removed by centrifugation at 40000 g for 30 minutes to give a 100% v/v saturated solution. A series of dilutions was made from this saturated solution to give further test concentrations of 0.10, 1.0 and 10% v/v saturated solution. Each prepared concentration was inverted several times to ensure adequate mixing and homogeneity.
Definitive Test
A nominal amount of test item (550 mg) was dispersed in 11 liters of test water with the aid of propeller stirring at approximately 1500 rpm for 24 hours. After 24 hours the stirring was stopped and any undissolved test item was removed by centrifugation at 40000 g for 30 minutes to give a 100% v/v saturated solution. A series of dilutions was made from this saturated solution to give further test concentrations of 10, 18, 32 and 56% v/v saturated solution. Each prepared concentration was inverted several times to ensure adequate mixing and homogeneity. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna
- Strain/clone: Not specified
- Justification for species other than prescribed by test guideline: Daphnia magna is a freshwater invertebrate representative of a wide variety of natural habitats, and can therefore be considered as an important non-target organism in freshwater ecosystems.
- Source: in house culture
- Age of parental stock (mean and range, SD): less than 24 hours old
- Feeding during test: not fed
ACCLIMATION
- Acclimation period: not specified
- Acclimation conditions (same as test or not): Adult daphnia were maintained in 150 mL glass beakers containing Elendt M7 medium in a temperature controlled room at 19 to 20 °C. 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: mixture of algal suspension (Desmodesmus subspicatus) and Tetramin®flake food suspension
- Feeding frequency: Daily
METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES: Gravid adults were isolated the day before initiation of the test, such that the young daphnids produced overnight were less than 24 hours old. These young were removed from the cultures and used for testing - Test type:
- static
- Water media type:
- other: Reconstituted water (ISO medium)
- Limit test:
- yes
- Total exposure duration:
- 48 h
- Post exposure observation period:
- 48 hours
- Hardness:
- 250 mg/L as CaCO3
- Test temperature:
- 21 to 22 °C
- pH:
- 7.8 ± 0.2
- Dissolved oxygen:
- 8.6 to 8.7 mg O2/L
- Nominal and measured concentrations:
- Nominal concentrations: 10, 18, 32, 56, 100 (% v/v)
Measured concentrations: 0.41, 0.76, 1.4, 2.3, 4.4 (mg/L) at 0 hours - Details on test conditions:
- TEST SYSTEM
- Test vessel: Beaker
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume: 150 mL glass beakers
- Aeration: Not aerated
- Type of flow-through (e.g. peristaltic or proportional diluter): static
- Renewal rate of test solution (frequency/flow rate): not specified
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- No. of vessels per vehicle control (replicates): 4
- Biomass loading rate: Not specified
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted water (ISO medium)
CaCl2.2H2O 294 mg/L
MgSO4.7H2O 123 mg/L
NaHCO3 64.75 mg/L
KCl 5.75 mg/L
The reconstituted water had a pH of 7.8 ± 0.2 adjusted (if necessary) with NaOH or HCl and was aerated until the dissolved oxygen concentration was approximately air-saturation value. The reconstituted water had an approximate theoretical total hardness of 250 mg/L as CaCO3.
OTHER TEST CONDITIONS
- Photoperiod: The lighting cycle was controlled to give a 16 hours light and 8 hours darkness cycle with 20 minute dawn and dusk transition periods.
- Light intensity: 586 to 634 Lux
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Any immobilization or adverse reactions to exposure were recorded at 24 and 48 hours after the start of exposure. The criterion of effect used was that daphnia were considered to be immobilized if they were unable to swim within 15 seconds after gentle agitation.
VEHICLE CONTROL PERFORMED: yes
RANGE-FINDING STUDY
- Test concentrations: nominal test concentrations of 0.10, 1.0, 10 and 100% v/v saturated solution.
- Results used to determine the conditions for the definitive study: yes - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 1.1 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks:
- effects on mobility observed at the 1.4 mg/L concentration
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.73 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- other: No effects observed
- Duration:
- 48 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 1.4 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- - Behavioural abnormalities: Sub-lethal effects of exposure were observed in the 32 and 56% v/v saturated solution test concentrations. This response was reduced mobility
- Observations on body length and weight: Not specified
- Other biological observations: No effects
- Mortality of control: No
- Other adverse effects control: No
- Abnormal responses: No - Results with reference substance (positive control):
- - Results with reference substance valid? Yes
No sub-lethal effects observed - Reported statistics and error estimates:
- The EC50 value at 48 hours and the slope of the response curve and its standard error were calculated by Probit analysis using Linear Maximum-Likelihood regression. The Lowest Observed Effect Concentration and the No Observed Effect Concentration at 24 and 48 hours were calculated using the Fisher’s Exact Binomial Test with Bonferroni correction. All results were calculated using the ToxRat Professional computer software package (TOXRAT).
Geometric Mean Measured Test Concentrations
The geometric mean measured test concentrations of the samples were calculated as follows using the measured test concentrations of replicates R1 – R4 pooled:
GM = √C0 C1
GM = geometric mean measured test concentration (mg/L)
C0 = measured concentration at the start of the test (mg/L)
C1 = measured concentration at the end of the test (mg/L) - Validity criteria fulfilled:
- yes
- Remarks:
- The test was considered to be valid since none of the control daphnids showed immobilization or other signs of disease/stress and that the oxygen concentration at the end of the test was equal to or greater than 3 mg/L in the control and test vessels.
- Conclusions:
- Sub-lethal effects of exposure were observed in the 32 and 56% v/v saturated solution test concentrations. This response was reduced mobility. Based on the effects observed the 48-hour EC50 was determined to be 1.1 mg/L, while the NOEC and LOEC were determined to be 0.73 and 1.4 mg/L, respectively.
- Executive summary:
A key 48-hour acute immobilization test was carried out to assess the acute toxicity of the test material (1,2-Cyclohexanedicarboxylic Acid, 1-butyl 2-(phenylmethyl) ester; CAS# 1200806-67-2) to Daphnia magna.
Following a preliminary range-finding test, twenty daphnids (4 replicates of 5 animals each) were exposed to an aqueous solution of the test item at nominal concentrations of 10, 18, 32, 56 and 100% v/v saturated solution for 48 hours at a temperature of approximately 21 to 22°C under static test conditions. Immobilization and any adverse reactions to exposure were recorded after 24 and 48 hours.
Chemical analysis of the test preparations at 0 hours showed measured test concentrations to range from 0.41 to 4.4 mg/L. Analysis of the test preparations at 48 hours showed measured test concentrations had declined, to between 0.38 and 3.8 mg/L (76% to 102% of the 0-Hour measured test concentrations) and hence it was considered appropriate to calculate the results based on the geometric mean measured test concentrations in order to give a “worst case”
analysis of the data.
Sub-lethal effects of exposure were observed in the 32 and 56% v/v saturated solution test concentrations. This response was reduced mobility. Based on the effects observed the 48-hour EC50 was determined to be 1.1 mg/L, while the NOEC and LOEC were determined to be 0.73 and 1.4 mg/L, respectively.
Reference
Table 1. Test Concentrations |
||||
Nominal Test Concentration (% v/v Saturated Solution) |
0 Hour Measured Concentration (mg/L) |
48 Hour Measured Concentration (mg/L) |
Geometric Mean Measured Test Concentration (mg/L)
|
Expressed as a Percentage of the 0 Hour Measured Concentration (%) |
10 |
0.41 |
0.38 |
0.39 |
95 |
18 |
0.76 |
0.70 |
0.73 |
96 |
32 |
1.4 |
1.4 |
1.4 |
100 |
56 |
2.3 |
1.8 |
2.0 |
87 |
100 |
4.4 |
3.8 |
4.1 |
93 |
Table 2. Cumulative Immobilization Data and Observations in the Definitive Test |
|||||||||||
Nominal Concentration (% v/v Saturated Solution) |
Geometric Mean Measured Concentration (mg/L) |
24 hours |
|||||||||
Cumulative Immobilized Daphnia (Initial Population: 5 Per Replicate) |
Observations |
||||||||||
R1 |
R2 |
R3 |
R4 |
Total |
% |
R1 |
R2 |
R3 |
R4 |
||
Control |
0 |
0 |
0 |
0 |
0 |
0 |
5N |
5N |
5N |
5N |
|
10 |
0.39 |
0 |
0 |
0 |
0 |
0 |
0 |
5N |
5N |
5N |
5N |
18 |
0.73 |
0 |
0 |
0 |
0 |
0 |
0 |
5N |
5N |
5N |
5N |
32 |
1.4 |
2 |
3 |
1 |
1 |
7 |
35 |
3R |
2R |
4R |
4R |
56 |
2.0 |
4 |
3 |
5 |
5 |
17 |
85 |
1R |
2R |
A.I |
A.I |
100 |
4.1 |
5 |
5 |
5 |
5 |
20 |
100 |
A.I |
A.I |
A.I |
A.I |
R1 – R4 = Replicates 1 to 4
N = No sub-lethal effects observed
R= Reduced mobility
A/I = All daphnia immobilized
Table 3. Cumulative Immobilization Data and Observations in the Definitive Test |
|||||||||||
Nominal Concentration (% v/v Saturated Solution) |
Geometric Mean Measured Concentration (mg/L) |
48 hours |
|||||||||
Cumulative Immobilized Daphnia (Initial Population: 5 Per Replicate) |
Observations |
||||||||||
R1 |
R2 |
R3 |
R4 |
Total |
% |
R1 |
R2 |
R3 |
R4 |
||
Control |
0 |
0 |
0 |
0 |
0 |
0 |
5N |
5N |
5N |
5N |
|
10 |
0.39 |
0 |
0 |
0 |
0 |
0 |
0 |
5N |
5N |
5N |
5N |
18 |
0.73 |
0 |
0 |
0 |
0 |
0 |
0 |
5N |
5N |
5N |
5N |
32 |
1.4 |
3 |
4 |
5 |
4 |
16 |
80 |
2R |
1R |
A.I |
1R |
56 |
2.0 |
5 |
5 |
5 |
5 |
20 |
100 |
A.I |
A.I |
A.I |
A.I |
100 |
4.1 |
5 |
5 |
5 |
5 |
20 |
100 |
A.I |
A.I |
A.I |
A.I |
R1 – R4 = Replicates 1 to 4
N = No sub-lethal effects observed
R= Reduced mobility
A/I = All daphnia immobilized
Description of key information
A key 48-hour acute immobilization test was carried out to assess the acute toxicity of the test material (1,2-Cyclohexanedicarboxylic Acid, 1-butyl 2-(phenylmethyl) ester; CAS# 1200806-67-2) to Daphnia magna.
Following a preliminary range-finding test, twenty daphnids (4 replicates of 5 animals each) were exposed to an aqueous solution of the test item at nominal concentrations of 10, 18, 32, 56 and 100% v/v saturated solution for 48 hours at a temperature of approximately 21 to 22°C under static test conditions. Immobilization and any adverse reactions to exposure were recorded after 24 and 48 hours.
Chemical analysis of the test preparations at 0 hours showed measured test concentrations to range from 0.41 to 4.4 mg/L. Analysis of the test preparations at 48 hours showed measured test concentrations had declined, to between 0.38 and 3.8 mg/L (76% to 102% of the 0-Hourmeasured test concentrations) and hence it was considered appropriate to calculate the results based on the geometric mean measured test concentrations in order to give a “worst case” analysis of the data.
Sub-lethal effects of exposure were observed in the 32 and 56% v/v saturated solution testconcentrations. This response was reduced mobility. Based on the effects observed the 48-hour EC50 for P1400 was determined to be 1.1 mg/L, while the NOEC and LOEC were determined to be 0.73 and 1.4 mg/L, respectively.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Dose descriptor:
- EC50
- Remarks:
- immobilisation
- Effect concentration:
- 1.1 mg/L
Additional information
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.