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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 800-884-5 | CAS number: 1154308-86-7
- 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
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 December 2012-19 January 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- Duplicate aliquots (ca. 20 mL) were removed from each tank at the commencement of the definitive test as 0 h samples and at test termination as 96 h samples.
Test samples were analysed according to the procedure established and validated under Charles River Study No. 220937, Procedure No. AP.2093.01. - Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: test solutions were prepared by addition of weighed amounts of the substance coating additives (at nominal concentrations of 62.62 mg, 125.05 mg, 250.13 mg, 500.00 mg and 1000.12 mg for tanks at 3.125, 6.25, 12.5, 25 and 50 mg/L, respectively) to 20 L of RFW and ultrasonicating for ca. 10-15 min to aid dissolution. The control tank contained RFW only. One tank was prepared at each test concentration. Seven rainbow trout were added to each tank within 30 min of preparation. - Test organisms (species):
- Oncorhynchus mykiss (previous name: Salmo gairdneri)
- Details on test organisms:
- TEST ORGANISM
- Common name: Rainbow Trout
- Source: Brow Well Fisheries,Skipton, England
- Age at study initiation: 12 months
ACCLIMATION
- Acclimation period: 17 days
- Acclimation conditions (same as test or not): same as test
- Type and amount of food: INICIO 917, fish fed at a rate of ca 1-2% of body weight per fish per day
- Feeding frequency: daily
- Health during acclimation (any mortality observed): all fish were in good health - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Post exposure observation period:
- The fish in the test were observed after 1, 4, 24, 48, 72 and 96 h. At the termination of the range finding and definitive tests, the length (from the tip of the snout to the caudal peduncle) and weight of each surviving fish was recorded.
- Hardness:
- 80.0 mg CaCO3/L
- Test temperature:
- All test tank temperatures were in the range: 15.0-15.6°C
- pH:
- All test tank pH values were in the range: pH 7.24-8.07
- Dissolved oxygen:
- The dissolved oxygen contration for all test tanks were in the range:83.6-98.8%
- Nominal and measured concentrations:
- Nominal concentrations: 0, 3.125, 6.25, 12.5, 25 and 50 mg/L
Mean measured concentrations: 0, 3.00, 5.94, 12.1, 23.9 and 48.4 mg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: tanks of ca.25 L capacity (moulded glass construction and covered with Perspex lids to minimise dust contamination, evaporation loss and fish escaping)
- Type: open
- Fill volume: 20 L
- Aeration: throughout test
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Conductivity of test tanks: 182.1-225µS/cm
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconsituted fresh water (prepared on site at Charles River)
- Intervals of water quality measurement: measured at test initiation and at 24 hour intervals in all test tanks
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2
- Range finding study
- Test concentrations: 0, 0.1, 1, 10 and 100 mg
- Results used to determine the conditions for the definitive study:
At 1 h exposure, all three fish at 100 mg/L were lying on the base of the tank in an inverted position, showing only limited movement. These fish were therefore removed and humanely euthanized to avoid additional stress. No further mortality or adverse effects were noted in any surviving fish throughout the 96 h test period.
The test solution at 100 mg/L appeared very slightly opaque. All other test solutions appeared clear and colourless throughout the test period. No precipitation of test item was observed. - Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 18 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 12.1 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- - Mortality of control: 0
- Sublethal observations / clinical signs:
Measured Concentrations of the substance Coating Additives in Test Solutions During the Test
Nominal Concentration of the substance coating additives (mg/L)
Time
(h)
Mean Measured Concentration of the substance coating additives (mg/L)
Overall Mean Measured Concentration of the substance coating additives (mg/L)
Deviation of 96 h Measured Concentration from 0 h Measured Concentration
(±%)
Control
0
96
ND
ND
ND
ND
NA
3.125
0
96
3.01
2.99
3.00
-0.7
6.25
0
96
5.90
5.97
5.94
+1.2
12.5
0
96
12.0
12.1
12.1
+0.8
25
0
96
24.0
23.8
23.9
-0.8
50
0
96
48.6
48.1
48.4
-1.0
ND = Not detected
NA = Not applicable
Cumulative Mortality Recorded During the Test
Time (h)
Mean Measured Concentration of the substance coating additives (mg/L)
Control
3.00
5.94
12.1
23.9
48.4
1
0
0
0
0
0
0
4
0
0
0
0
0
0
24
0
0
0
0
7
7
48
0
0
0
0
7
7
72
0
0
0
0
7
7
96
0
0
0
0
7
7
Seven fish were tested at each concentration.
Surviving Fish Lengths and Weights During the Test
Mean Measured oncentration of the substance coating additives (mg/L)
Fish No.
Length
(cm)
Weight
(g)
Control
1
2
3
4
5
6
7
5.56
4.67
5.70
4.78
5.38
5.98
5.53
2.4511
1.4784
2.5590
1.5285
2.3828
3.0801
2.3977
3.00
1
2
3
4
5
6
7
5.69
5.92
5.88
5.43
5.55
5.49
4.54
2.4876
2.6038
2.6342
2.2131
2.5492
2.1428
1.2804
5.94
1
2
3
4
5
6
7
5.99
5.52
5.37
5.79
5.31
4.73
5.55
3.2106
2.2365
2.2396
2.4599
2.0037
1.3484
2.5417
12.1
1
2
3
4
5
6
7
5.99
5.48
5.77
6.00
5.61
5.29
5.30
3.2104
2.3246
2.3196
3.2265
2.5034
2.0848
2.1136
Note: No fish survived at exposure concentrations of 23.9 and 48.4 mg/L.
Test Solution Quality Parameters During the Test
Time/Parameter
Mean Measured Concentration of the substance coating additives (mg/L)
Control
3.00
5.94
12.1
23.9
48.4
0 hour
pH
Temperature (°C)
Conductivity (µS/cm)
Dissolved Oxygen (% ASV)
7.43
15.1
183.9
87.7
7.42
15.2
183.0
83.6
7.49
15.4
182.8
85.7
7.51
15.4
182.5
84.2
7.49
15.4
182.1
86.0
7.43
15.4
183.0
86.6
24 hour
pH
Temperature (°C)
Conductivity (µS/cm)
Dissolved Oxygen (% ASV)
7.47
15.4
220
89.9
7.32
15.5
220
90.1
7.27
15.6
221
90.4
7.24
15.2
222
92.3
7.26
15.2
223
94.4
7.27
15.4
225
95.1
48 hour
pH
Temperature (°C)
Conductivity (µS/cm)
Dissolved Oxygen (% ASV)
8.04
15.4
213
97.6
8.07
15.4
215
96.9
7.93
15.4
216
92.9
7.88
15.0
216
96.5
7.89
15.1
215
98.3
7.92
15.3
217
98.8
72 hour
pH
Temperature (°C)
Conductivity (µS/cm)
Dissolved Oxygen (% ASV)
7.64
15.4
219
93.0
7.41
15.4
219
91.1
7.24
15.4
220
90.0
7.25
15.0
221
93.3
7.28
15.1
219
95.0
7.24
15.3
220
96.6
96 hour
pH
Temperature (°C)
Conductivity (µS/cm)
Dissolved Oxygen (% ASV)
7.88
15.4
208
90.1
7.83
15.4
207
88.4
7.79
15.4
207
89.4
7.83
15.1
209
87.2
7.85
15.1
208
88.4
7.86
15.3
208
90.9
ASV = Air saturation value
- Validity criteria fulfilled:
- yes
- Conclusions:
- Under the study conditions, the 96 h LC50 and NOEC of the test substance for rainbow trout was estimated to be 18.0 and 12.1 mg/L respectively, based on arithmetic mean measured concentrations
- Executive summary:
A study was conducted to determine the acute toxicity of test substance to rainbow trout (Oncorhynchus mykiss) according to OECD Guideline 203, in compliance with GLP. Based on the results of a range finding test, the definitive test was conducted at nominal concentrations of 0, 3.125, 6.25, 12.5, 25 and 50 mg/L under static conditions. One tank was prepared at each test concentration and 7 fish added to each. The total test period was 96 h and samples for analytical confirmation of actual exposure concentrations were taken at the start (0 h) and at the end of the test (96 h). Chemical analysis of test samples taken at 0 and 96 h indicated that concentrations of the test substance were maintained within the range 99.0-101.2% of the initial measured values. No undissolved test substance was observed in the test tanks throughout the test period. Based on these results, the mean measured concentrations of the test substance were calculated to be 0, 3.00, 5.94, 12.1, 23.9 and 48.4 mg/L, respectively. The fish were observed at regular intervals for mortality and sub-lethal effects (length and body weight) in the surviving fish. The test conditions (pH, temperature, conductivity and dissolved oxygen) were measured daily during the test and found to be within the standard ranges. No fish survived in the top two test concentrations. Due to the lack of fractional mortality data at the 24, 48, 72 and 96 h time points, LC50 values were estimated by taking the arithmetic mean of the 0% and 100% mortality concentrations. The no observed effect concentration (NOEC) was estimated for mortality. Under the study conditions, the 96 h LC50 and NOEC of the test substance for rainbow trout was estimated to be 18.0 and 12.1 mg/L respectively, based on arithmetic mean measured concentrations (Knight, 2013).
Reference
Description of key information
The 96-h LC50, NOEC of the test substance in fish was determined to be 18 mg/L and 12.1 mg/L (measured; arithmetic mean) respectively.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Dose descriptor:
- LC50
- Effect concentration:
- 18 mg/L
Additional information
A study was conducted to determine the acute toxicity of test substance to rainbow trout (Oncorhynchus mykiss) according to OECD Guideline 203, in compliance with GLP. Based on the results of a range finding test, the definitive test was conducted at nominal concentrations of 0, 3.125, 6.25, 12.5, 25 and 50 mg/L under static conditions. One tank was prepared at each test concentration and 7 fish added to each. The total test period was 96 h and samples for analytical confirmation of actual exposure concentrations were taken at the start (0 h) and at the end of the test (96 h). Chemical analysis of test samples taken at 0 and 96 h indicated that concentrations of the test substance were maintained within the range 99.0-101.2% of the initial measured values. No undissolved test substance was observed in the test tanks throughout the test period. Based on these results, the mean measured concentrations of the test substance were calculated to be 0, 3.00, 5.94, 12.1, 23.9 and 48.4 mg/L, respectively. The fish were observed at regular intervals for mortality and sub-lethal effects (length and body weight) in the surviving fish. The test conditions (pH, temperature, conductivity and dissolved oxygen) were measured daily during the test and found to be within the standard ranges. No fish survived in the top two test concentrations. Due to the lack of fractional mortality data at the 24, 48, 72 and 96 h time points, LC50 values were estimated by taking the arithmetic mean of the 0% and 100% mortality concentrations. The no observed effect concentration (NOEC) was estimated for mortality. Under the study conditions, the 96 h LC50 and NOEC of the test substance for rainbow trout was estimated to be 18.0 and 12.1 mg/L respectively, based on arithmetic mean measured concentrations (Knight, 2013).
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.