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EC number: 285-107-2 | CAS number: 85029-82-9
- 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:
- Experimental start date: 12 June 2017 Experimental completion date: 30 June 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Physical state/Appearance: Clear amber viscous liquid
Purity: 100% product
Expiry Date: 24 June 2018
Storage Conditions: Room temperature, in the dark - Analytical monitoring:
- yes
- Details on sampling:
- Due to the low aqueous solubility and complex nature of the test item, for the purposes of the study the test medium was prepared as a Water Accommodated Fraction (WAF) of the test item.
A nominal amount of test item (2200 mg) was added to the surface of 22 liters of test water to give the 100 mg/L loading rate. - Vehicle:
- no
- Remarks:
- Due to the low aqueous solubility and complex nature of the test item, for the purposes of the study the test medium was prepared as a Water Accommodated Fraction (WAF) of the test item.
- Details on test solutions:
- A nominal amount of test item (2200 mg) was added to the surface of 22 liters of test water to give the 100 mg/L loading rate. After the addition of the test item, the test water was stirred by magnetic stirrer using a stirring rate such that a vortex was formed to give a dimple at the water surface. The stirring was stopped after 23 hours and the mixture allowed to stand for
1 hour. A wide bore glass tube, covered at one end with Nescofilm was submerged into the vessel, sealed end down, to a depth of approximately 5 cm from the bottom of the vessel. No particles or micro-dispersions of test item were observed by microscopic observations, however, the water column of the 100 mg/L loading rate was a cloudy white emulsion and hence it was considered justifiable to remove the WAF by filtering through a glass wool plug (2-4 cm in length) and filter paper. A wide bore glass tube, covered at one end with Nescofilm was submerged into the vessel, sealed end down, to a depth of approximately 5 cm from the bottom of the vessel. A length of Tygon tubing was inserted into the glass tube and pushed through the Nescofilm seal. A glass wool plug was inserted into the opposite end of the tubing and the WAF removed by mid-depth siphoning (the first 75-100 mL discarded) before passing through a filter paper to give the 100 mg/L loading rate WAF. Microscopic observations were performed on the WAFs after filtering and showed no particles or micro- dispersions of test item to be present, however, the preparations were observed to remain cloudy. - Test organisms (species):
- Oncorhynchus mykiss (previous name: Salmo gairdneri)
- Details on test organisms:
- The test was carried out using juvenile rainbow trout (Oncorhynchus mykiss). Fish were obtained from Brow Well Fisheries Limited, Hebden, near Skipton, Yorkshire, UK and maintained in-house since 31 May 2017. Fish were maintained in a glass fiber tank with a "single pass" water renewal system. Fish were acclimatized to test conditions from 19 June 2017 to 26 June 2017. The lighting cycle was controlled to give a 16 hours light and 8 hours darkness cycle with 20 minute dawn and dusk transition periods.
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Test temperature:
- 14 to 15 ºC
- pH:
- Between 7.8 @ 8.2
- Dissolved oxygen:
- dissolved oxygen content of greater than or equal to 9.3 mg O2/L
- Salinity:
- N/A
- Nominal and measured concentrations:
- A "Limit test" was conducted at a single loading rate of 100 mg/L
- Reference substance (positive control):
- no
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- not specified
- Conc. based on:
- other: loading rate WAF
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 96-Hour LL50 value of greater than 100 mg/L loading rate WAF. The No Observed Effect Loading rate was 100 mg/L loading rate WAF.
- Key result
- Duration:
- 96 h
- Dose descriptor:
- other: The No Observed Effect Loading rate
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- not specified
- Conc. based on:
- other: loading rate WAF
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: The No Observed Effect Loading rate was 100 mg/L loading rate WAF.
- Details on results:
- The acute toxicity of the test item to the freshwater fish rainbow trout (Oncorhynchus mykiss) has been investigated and gave a 96-Hour LL50 value of greater than 100 mg/L loading rate WAF. The No Observed Effect Loading rate was 100 mg/L loading rate WAF.
- Sublethal observations / clinical signs:
Cumulative mortality data from the exposure of rainbow trout to the test item during the range-finding test are given in Table 1.
The results showed no mortalities at 1.0, 10 and 100 mg/L loading rate WAF, additionally, there were no sub-lethal effects of exposure observed during the range-finding test.
Based on this information, a single loading rate of 100 mg/L was selected for the definitive test. This experimental design conforms to a "Limit test" to confirm that no mortalities or sub-lethal effects of exposure were observed.
Definitive Test
Total Organic Carbon (TOC) analysis of the fresh test preparations at 0 and 72 hours (see Annex 3) showed measured concentrations of 66 and 102 mg Carbon/L. TOC analysis of the old test solutions at 24 and 96 hours showed measured concentrations of 56 and 19 mg Carbon/L.
The dissolved test item may have been one or several components of the test item. Given that toxicity cannot be attributed to a single component or mixture of components but to the test item as a whole, the results were based on nominal loading rates only.
Cumulative mortality data from the exposure of rainbow trout to the test item during the definitive test are given in Table 2.
There were no mortalities in 7 fish exposed to a 100 mg/L loading rate WAF for a period of 96 hours. Inspection of the mortality data gave the following results:
Time (h) LL50 *
(mg/L Loading Rate WAF)
1 >100
3 >100
6 >100
24 >100
48 >100
72 >100
96 >100
* 95% confidence limits could not be calculated
It was considered unnecessary and unrealistic to test at loading rates in excess of 100 mg/L.
There were no sub-lethal effects of exposure observed in 7 fish exposed to a 100 mg/L loading rate WAF for a period of 96 hours.
The test was considered to be valid given that none of the control fish died or showed signs of stress during the test and that the oxygen concentration at the end of the test was greater than or equal to 60% of ASV (6.1 mg O2/L) in the control and test vessels.
During the range-finding test, after 48 hours of exposure, the dissolved oxygen concentration in the 100 mg/L test media was measured at 4.4 mg O2/L and therefore below the 60% ASV (6.1 mg O2/L) validity criteria, as a result the aeration rate was increased. Given that no mortalities or sub-lethal effects were observed the reduced dissolved oxygen concentration was considered not to have adversely affected the results of the test.
The results of the water quality measurements are given in Table 3. Temperature was maintained at 14 Deg C to 15 Deg C throughout the test, while there were no treatment related differences for oxygen concentration or pH.
The vortex depth was recorded at the start and end of each mixing period and was observed to be a dimple at the water surface on each occasion.
Observations on the test media were carried out during the mixing and testing of the WAF.
At the start of each mixing period the 100 mg/L loading rate was observed to be clear colorless water column with test item floating at the water surface. After 23 hours stirring and a 1-Hour standing period the 100 mg/L loading rate was observed as a cloudy white water column. Microscopic inspection of the WAF showed no micro-dispersions or undissolved test item to be present, however, given that the test item had formed an emulsion the WAF was filtered through a 2-4 cm glass wool plug and filter paper. Microscopic examination after filtering showed no particles or micro-dispersions of the test item to be present, however, the test solution was observed to remain cloudy in appearance. During the test the 100 mg/L loading rate was observed to be a cloudy emulsion.
Table 1 Cumulative Mortality Data in the Range-finding Test
Nominal Loading Rate (mg/L)
Cumulative Mortality (Initial Population = 3)
1 Hour
3 Hours
6 Hours
24 Hours
48 Hours
72 Hours
91 Hours
Control
0
0
0
0
0
0
0
1.0
0
0
0
0
0
0
0
10
0
0
0
0
0
0
0
100
0
0
0
0
0
0
0
Table 2 Cumulative Mortality Data in the Definitive Test
Nominal Loading Rate (mg/L)
Cumulative Mortality (Initial Population = 7)
%
Mortality
1
Hour
3
Hours
6
Hours
24
Hours
48
Hours
72
Hours
96
Hours
96
Hours
Control
0
0
0
0
0
0
0
0
100
0
0
0
0
0
0
0
0
Table 3 Water Quality Measurements
Nominal Loading Rate (mg/L)
Time (Hours)
0 Hours (Fresh Media)
24 Hours (Old Media)
pH
mg O2/L
T ºC
pH
mg O2/L
T°C
Control
7.8
9.8
15
7.9
9.2
15
100
7.8
9.9
15
8.0
9.3
15
Nominal Loading Rate (mg/L)
Time (Hours)
24 Hours (Fresh Media)
48 Hours (Old Media)
pH
mg O2/L
T ºC
pH
mg O2/L
T°C
Control
7.9
9.8
15
8.3
9.5
15
100
7.9
9.9
15
8.2
9.1
15
Nominal Loading Rate (mg/L)
Time (Hours)
48 Hours (Fresh Media)
72 Hours (Old Media)
pH
mg O2/L
T ºC
pH
mg O2/L
T°C
Control
7.7
9.9
15
7.9
9.2
15
100
7.8
9.8
14
7.9
7.6
15
Nominal LoadingRate (mg/L)
Time (Hours)
72 Hours (Fresh Media)
96 Hours (Old Media)
pH
mg O2/L
T ºC
pH
mg O2/L
T°C
Control
8.0
9.7
15
8.1
9.7
15
100
7.9
9.6
15
8.0
8.9
15
Annex 2 Typical Water Quality Characteristics
Typical Water Characteristics for Supply Zone ZDB13
Analysis
Typical Value
Units
Hardness Level
Slightly Hard
N/A
Hardness clark
8.76
Degrees clark
Hardness french
12.52
French degrees
Hardness german
7.01
German degrees
Aluminium
7.46
mg Al/L
Chlorine
0.32
mg/L
Coliformbacteria
0
no./100mL
Colour
0.6
mg/l Pt/Co
Conductivity
345
μS/cm at 20°C
E.Colibacteria
0
no./100mL
Fluoride
0.24
mg F/L
Iron
19.9
μg Fe/L
Manganese
2.9
μg Mn/L
Nitrate
7.61
mg NO3/L
Odour
0
Dilution number
Pesticides
0
μg/L
pH
7.66
pH Value
Sodium
22.35
mg Na/L
Taste
0
Dilution number
Plumbing Metals
Copper
0.02
mg Cu/L
Lead
0.51
μg Pb/L
Nickel
3.1
μg Ni/L
Source:https://www.stwater.co.uk/my-supply/water-quality/check-my-water-quality/
Annex 3 Total Organic Carbon Analysis
METHOD OF ANALYSIS
Summary
The concentration of Total Organic Carbon (TOC) in the WAF was determined by TOC analysis.
Samples
In the range-finding test, samples of the control and each loading rate were taken for analysis at 0 hours (fresh media) and 24 hours (old media).
In the definitive test, samples of the control and 100 mg/L loading rate WAF were taken for analysis at 0 and 72 hours (fresh media), 24 and 96 hours (old media).
Standards
Standard solutions of potassium hydrogen phthalate (C8H5KO4) were prepared in reverse osmosis water at concentrations of 10, 20, 50 and 100 mg Total Carbon/L. Standard solutions of sodium carbonate (Na2CO3) were prepared in reverse osmosis water at concentrations of 5, 10, 20 and 33.33 mg Inorganic Carbon/L. These solutions were used for calibration of the carbon analyzer.
Procedure
The standard and sample solutions were analyzed for TOC using a Shimadzu TOC-VCPH high temperature Total Organic Carbon Analyzer using the following conditions:
Total Carbon Channel
Temperature : 680 ºC
Carrier gas : zero grade air
Carrier gas flow rate : 150 cc/min regulated at 50 psi
Catalyst : platinum based
Injection volume : 50 µL
Inorganic Carbon Channel
Temperature : ambient
Carrier gas : zero grade air
Carrier gas flow rate : 150 cc/min regulated at 50 psi Catalyst : 25% orthophosphoric acid
Injection volume : 50 µL
RESULTS
Range-finding Test
Samples
Nominal Loading Rate (mg/L)
Concentration of TOC (mg C/L)
Concentration of TOC Corrected for Control (mg C/L)
0 Hours (Fresh Media)
Control
1.34
-
1.0
2.03
0.69
10
3.13
1.8
100
22.40
21
24 Hours (Old Media)
Control
<LOQ
-
1.0
<LOQ
<LOQ
10
3.04
3.0
100
21.65
22
DefinitiveTest
Samples
Nominal Loading Rate (mg/L)
Concentration of TOC (mg C/L)
Concentration of TOC Corrected for Control (mg C/L)
0 Hours (Fresh Media)
Control
<LOQ
-
100
66.00
66
24 Hours (Old Media)
Control
<LOQ
-
100
56.38
56
72 Hours (Fresh Media)
Control
<LOQ
-
100
102.3
102
96 Hours (Old Media)
Control
<LOQ
-
100
19.26
19
LOQ = Limit of quantification which was considered to be 1.0 mg C/L
- Validity criteria fulfilled:
- yes
- Conclusions:
- The acute toxicity of the test item to the freshwater fish rainbow trout (Oncorhynchus mykiss) has been investigated and gave a 96-Hour LL50 value of greater than 100 mg/L loading rate WAF. The No Observed Effect Loading rate was 100 mg/L loading rate WAF.
- Executive summary:
A study was performed to assess the acute toxicity of the test item to rainbow trout (Oncorhynchus mykiss). The method followed was designed to be compatible with the OECD Guidelines for Testing of Chemicals (1992) No 203, "Fish, Acute Toxicity Test" referenced as Method C.1 of Commission Regulation (EC) No. 440/2008.
Due to the low aqueous solubility and complex nature of the test item, for the purposes of the test, the test medium was prepared as a Water Accommodated Fraction (WAF).
Following a preliminary range-finding test, seven fish were exposed to a Water Accommodated Fraction (WAF) of the test item, at a single nominal loading rate of 100 mg/L for a period of 96 hours at a temperature of 14 to 15 ºC under semi-static test conditions. The number of mortalities and any sub-lethal effects of exposure in each test and control vessel were determined 1, 3 and 6 hours after the start of exposure and then daily throughout the test until termination after 96 hours.
Total Organic Carbon (TOC) analysis of the fresh test media at 0 and 72 hours showed measured concentrations of 66 and 102 mg/L respectively. TOC analysis of the old test media at 24 and 96 hours showed measured concentrations of 56 and 19 mg/L respectively. Given that the toxicity cannot be attributed to a single component or a mixture of components, but to the test item as a whole, the results were based on nominal loading rates only.
Exposure of rainbow trout to the test item gave LL50 values of greater than 100 mg/L loading rate WAF. The No Observed Effect Loading Rate was 100 mg/L loading rate WAF.
It was considered unnecessary and unrealistic to test at loading rates in excess of 100 mg/L loading rate WAF.
Reference
Description of key information
The acute toxicity of the test item to the freshwater fish rainbow trout (Oncorhynchus mykiss) has been investigated and gave a 96-Hour LL50 value of greater than 100 mg/L loading rate WAF. The No Observed Effect Loading rate was 100 mg/L loading rate WAF.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 100 mg/L
Additional information
A study was performed to assess the acute toxicity of the test item to rainbow trout (Oncorhynchus mykiss). The method followed was designed to be compatible with the OECD Guidelines for Testing of Chemicals (1992) No 203, "Fish, Acute Toxicity Test" referenced as Method C.1 of Commission Regulation (EC) No. 440/2008.
Due to the low aqueous solubility and complex nature of the test item, for the purposes of the test, the test medium was prepared as a Water Accommodated Fraction (WAF).
Following a preliminary range-finding test, seven fish were exposed to a Water Accommodated Fraction (WAF) of the test item, at a single nominal loading rate of 100 mg/L for a period of 96 hours at a temperature of 14 to 15 ºC under semi-static test conditions. The number of mortalities and any sub-lethal effects of exposure in each test and control vessel were determined 1, 3 and 6 hours after the start of exposure and then daily throughout the test until termination after 96 hours.
Total Organic Carbon (TOC) analysis of the fresh test media at 0 and 72 hours showed measured concentrations of 66 and 102 mg/L respectively. TOC analysis of the old test media at 24 and 96 hours showed measured concentrations of 56 and 19 mg/L respectively. Given that the toxicity cannot be attributed to a single component or a mixture of components, but to the test item as a whole, the results were based on nominal loading rates only.
Exposure of rainbow trout to the test item gave LL50 values of greater than 100 mg/L loading rate WAF. The No Observed Effect Loading Rate was 100 mg/L loading rate WAF.
It was considered unnecessary and unrealistic to test at loading rates in excess of 100 mg/L loading rate WAF.
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