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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
- 1990-02-07 to 1990-02-09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 797.1300 (Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids)
- Deviations:
- not specified
- GLP compliance:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source: Monsanto (ABC reference No. TS-3761)
- Purity test: >95%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Stored at room temperature - Analytical monitoring:
- no
- Details on sampling:
- The water quality parameters of temperature, dissolved oxygen and pH were measured in the control and all test levels at 0- and 48-hours of testing.
- Vehicle:
- no
- Details on test solutions:
- Method of application: A half-litre proportional diluter system described by Mount and Brungs, utilising a Hamilton Micro Lab 420 syringe dispenser, was used for the intermittent introduction of dilution water and XP-2563 into the test chambers. The system contained 7 sets of 4 replicate 1-L test chambers designated as control, solvent control, and levels 1-5. Flow-splitting chambers were utilised to thoroughly mix and divide each test concentration for delivery to the test chambers. To minimise turbulence, the influent water was introduced into the test chambers via 14-gauge hypodermic needles.
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia Magna
- Strain/clone: ABC Labs in-house culture
- Age at study initiation (mean and range, SD): <24 hours
- Stage and instar at study initiation: 1st instar
- Feeding during test : Daphnids were fed a suspension of algae (Selenastrum capricornutum) supplimented with a suspension of trout chow and yeast.
ACCLIMATION
- Acclimation period: From birth
- Acclimation conditions (same as test or not): Same as test - Test type:
- flow-through
- Water media type:
- other: mix of Reverse osmosis water and ABC Well water
- Limit test:
- no
- Total exposure duration:
- 48 h
- Hardness:
- 160-180 mg/L
- Test temperature:
- 20°C
- pH:
- 8.0
- Dissolved oxygen:
- 0 hours 8.1 mg/L control, 7.8-8.1 mg/L in solvent control/dose groups
48 hours- 8.3-8.4 mg/L - Nominal and measured concentrations:
- Nominal: Control; solvent control; 0.12; .24; 0.5; 1.0; 2.0 mg/L
Measured: Control; Solvent control; 0.063; 0.23; 0.37; 1.1; 2.0 mg/L - Details on test conditions:
- Test system
A half-litre proportional diluter system described by Mount and Brungs, utilising a Hamilton Micro Lab 420 syringe dispenser, was used for the intermittent introduction of dilution water and XP-2563 into the test chambers. The system contained 7 sets of 4 replicate 1-L test chambers designated as control, solvent control, and levels 1-5. Flow-splitting chambers were utilised to thoroughly mix and divide each test concentration for delivery to the test chambers. To minimise turbulence, the influent water was introduced into the test chambers via 14-gauge hypodermic needles. 1-L glass beakers with notched drains covered with 50-mesh stainless steel screen to prevent daphnid escapes were used as test chambers. The test chambers were labelled A-D and had 5 daphnids each placed in them. The dilution water used was a blend of reverse osmosis water and ABC well water, and was delivered to each test chamber at an average rate of 3.6 ml/chamber/minute, which was sufficient to replace the 1-L volume ~5.1x in 24 hours. The test chambers were immersed in a water bath held at 20°C.
- No. of organisms per vessel: 5 daphnia per replicate, 20 per concentration used overall
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- Loading factorL ~1 daphnid for 200 m. of solution
OTHER TEST CONDITIONS
- Photoperiod: 16-hour daylight 8-hour darkness, including 30 min transition period.
- Light intensity: historically 50-70 footcandles intensity from fluorescent light bulbs
RANGE-FINDING STUDY
- Test concentrations: 0.3; 1.0; 3.0 mg/L
- Results used to determine the conditions for the definitive study: Immobility observed at 1.0 and 3.0 mg/L - Reference substance (positive control):
- no
- Key result
- Duration:
- 4 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 2 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Key result
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 2 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 0.52 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.063 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- 4-, 24-, and 48-hour EC50 values for XP-2563 were >2.0, >2.0, and 0.52 mg/L respectively. All results were based on the mean measured concentrations of 0.063, 0.23, 0.37, 1.1, and 2.0 mg/L. The NOEC based on lack of immobility and other abnormal effects was 0.063 mg/L and the dose-response slope was 1.5 after 48 hours. 1 immobile daphnid in the solvent control and 0.063 mg/L was considered aberrant and not a compound-related effect.
- Reported statistics and error estimates:
- The EC50 statistic and its 95% confidence limit was calculated by a computerised EC50/LC50 program using the binomial, the moving average, and the probit tests, data permitting.
3 different methods of analyzing the data were used due to no one method of analysis being appropriate for all possible sets of data that may be obtained. - Conclusions:
- The 48-hour EC50 was 0.52 mg/L (95% confidence intervals of 0.34 and 0.85 mg/L). The 48-hour no effect concentration was 0.063 mg/L.
- Executive summary:
The definitive flow-through acute toxicity of XP-2563 to Daphnia magna was conducted from February 7 1990 to February 9 1990. The study was conducted at the following nominal concentrations: 0.12, 0.50, 1.0, and 2.0 mg/L. 20 1st-instar daphnids were exposed to each of the test concentrations and control.
Water samples were collected at 0- and 48-hours from the control and test levels and were returned to Monsanto Company for analysis. Analysis was conducted using Monsanto method #MSL-9864, ES-90-M-1. The mean measured values of XP-2563 were: 0.063, 0.23, 0.37, 1.1 and 2.0 mL/L. All results are based on the mean measured values. Water quality parameters of temperature, dissolved oxygen, and pH were measured at 0- and 48-hours and were determined to be within acceptable limits. The overall ranges for these parameters were: daily diluter-temperature observations = 20-21°C, pH = 8.0 – 8.1, and dissolved oxygen = 7.8 – 8.4 mg/L.
The 48-hour EC50 was 0.52 mg/L (95% confidence intervals of 0.34 and 0.85 mg/L). The 48-hour no effect concentration was 0.063 mg/L.
Reference
Table 1
Test Compound |
48-hour EC50 (95% confidence intervals) (mg/L) |
48-hour no-effect concentration (mg/L) |
XP-2563 |
0.52 (0.34 and 0.85) |
0.063 |
Table 2. Acute Flow-through toxicity of XP-2563 to Daphnia Magna
Parameter |
4 hours |
24 hours |
48 hours |
EC50 (mg/L) |
>2.0 |
>2.0 |
0.52 |
95% Confidence limits (mg/L) |
Could not be determined |
Could not be determined |
0.32 and 0.85 |
Statistical method used |
Bionomial |
Bionomial |
Moving average |
Bioassay conducted at 20°C
The 48-hour no-effect concentration was 0.063 mg/L which is based on the lack of immobility and other abnormal effects. The single immobile daphnid observed in this concentration was considered aberrant
The 48-hour dose response slope = 1.5
Table 3. Individual immobility and behavioural observations during the acute toxicity test of XP-2563 to Daphnia magna
Mean measured test conc. (mg/L) |
Replicate |
Number placed in test vessel |
4-hours |
24-hours |
48-hours |
|||
Cumm. Immob. |
Obs. |
Cumm. Immob. |
Obs. |
Cumm. Immob. |
Obs. |
|||
Control |
A |
5 |
0 |
- |
0 |
- |
|
- |
B |
5 |
0 |
- |
0 |
- |
|
- |
|
C |
5 |
0 |
- |
0 |
- |
|
- |
|
D |
5 |
0 |
- |
0 |
- |
|
- |
|
Solvent Control |
A |
5 |
0 |
- |
1 |
4 N |
1 |
4 N |
B |
5 |
0 |
- |
0 |
- |
|
- |
|
C |
5 |
0 |
- |
0 |
- |
|
- |
|
D |
5 |
0 |
- |
0 |
- |
|
- |
|
0.063 |
A |
5 |
0 |
- |
1 |
4 N |
1 |
4 N |
B |
5 |
0 |
- |
0 |
- |
|
- |
|
C |
5 |
0 |
- |
0 |
- |
|
- |
|
D |
5 |
0 |
- |
0 |
- |
|
- |
|
0.23 |
A |
5 |
0 |
- |
0 |
- |
3 |
2 OB |
B |
5 |
0 |
- |
0 |
- |
3 |
2 OB |
|
C |
5 |
0 |
- |
0 |
- |
0 |
3 OB; 2 N |
|
D |
5 |
0 |
- |
0 |
- |
2 |
2 OB; 1 N |
|
0.37 |
A |
5 |
0 |
- |
0 |
- |
3 |
2 OB |
B |
5 |
0 |
- |
0 |
- |
2 |
2 OB; 1N |
|
C |
5 |
0 |
- |
0 |
- |
2 |
3 OB |
|
D |
5 |
0 |
- |
0 |
- |
2 |
2 OB; 1 N |
|
1.1 |
A |
5 |
0 |
- |
0 |
- |
3 |
2 OB |
B |
5 |
0 |
- |
0 |
- |
2 |
3 OB |
|
C |
5 |
0 |
- |
0 |
- |
2 |
2 OB |
|
D |
5 |
0 |
- |
0 |
- |
3 |
2 OB |
|
2.0 |
A |
5 |
0 |
- |
0 |
- |
4 |
1 OB |
B |
5 |
0 |
- |
0 |
- |
5 |
- |
|
C |
5 |
0 |
- |
0 |
- |
4 |
1 OB |
|
D |
5 |
0 |
- |
0 |
- |
4 |
1 OB |
Unless otherwise indicated the test water was clear and free of participate and all daphnids were normal in appearance in behaviour. The following abbreviations were used for observations: OB = On the bottom, N = Normal
Immobility not considered to be a compound related effect
One daphnid missing: thought to have escaped since it was present at 0 and 4-hours.
Table 4. Percent immobile and water quality measurements during the acute flow-through toxicity test of XP-2563 with Daphnia magna
Nominal conc. (mg/L) |
Percent immobile |
Water Quality |
|||||||
0 hours |
48 hours |
||||||||
4-hrs |
24-hrs |
48-hrs |
Temp.* (°C) |
D.O†(mg/L) |
pH‡ |
Temp. (°C) |
D.O (mg/L) |
pH |
|
Control |
0 |
0 |
|
21 |
8.1 |
8.0 |
20 |
8.3 |
8.1 |
Solvent Control |
0 |
5 |
5 |
21 |
7.8 |
8.0 |
20 |
8.4 |
8.1 |
0.063 |
0 |
5 |
5 |
21 |
7.8 |
8.0 |
20 |
8.3 |
8.1 |
0.23 |
0 |
0 |
40 |
21 |
7.9 |
8.0 |
20 |
8.3 |
8.1 |
0.37 |
0 |
0 |
45 |
21 |
7.9 |
8.0 |
20 |
8.3 |
8.1 |
1.1 |
0 |
0 |
53 |
21 |
7.8 |
8.0 |
20 |
8.4 |
8.1 |
2.0 |
0 |
0 |
85 |
21 |
8.1 |
8.0 |
20 |
8.4 |
8.1 |
*= Temperatures measured with mercury thermometer
†= Dissolved oxygen concentrations measured with dissolved oxygen probe (YSI model 54 arc)
‡= pH measured with pH probe (Beckman model 39831) used with Corning model 140 pH and mV meter.
Note: Dissolved oxygen saturation at the test temperatures of 20 and 21°C are 8.7 and 8.5 mg/L, corrected for altitudinal pressure of ABC laboratories. The temperature listed here is measured directly on the water sample used for water chemistry. These values are not taken from the diluter observations.
Description of key information
The 48-hour EC50 of XP-2563 in Daphnia magna was determined to be 0.52 mg/L (95% confidence intervals of 0.34 and 0.85 mg/L) while the 48-hour no effect concentration was 0.063 mg/L.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 0.52 mg/L
Additional information
A definitive flow-through acute toxicity of XP-2563 to Daphnia magna was conducted (Analytical Bio-chemistry Laboratories Inc., 1990b). The study was conducted at the following nominal concentrations: 0.12, 0.50, 1.0, and 2.0 mg/L. 20 1st-instar daphnids were exposed to each of the test concentrations and control.
Water samples were collected at 0- and 48-hours from the control and test levels and were returned to Monsanto Company for analysis. Analysis was conducted using Monsanto method #MSL-9864, ES-90-M-1. The mean measured values of XP-2563 were: 0.063, 0.23, 0.37, 1.1 and 2.0 mL/L. All results are based on the mean measured values. Water quality parameters of temperature, dissolved oxygen, and pH were measured at 0- and 48-hours and were determined to be within acceptable limits. The overall ranges for these parameters were: daily diluter-temperature observations = 20-21°C, pH = 8.0 – 8.1, and dissolved oxygen = 7.8 – 8.4 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.