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EC number: 203-105-1 | CAS number: 103-37-7
- 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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Experimental test result performed according to the guideline.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- GLP compliance:
- no
- Analytical monitoring:
- no
- Vehicle:
- no
- Details on test solutions:
- Method: The stock solution prepared as 2g /4 liter, with the concentration of 500 mg/L and was kept for 4 hours stirring. After the completion of stirring, the sample was run through HPLC system for getting the actual water solubility of the test substance. The actual solubility obtained was 122.66 mg/L. From this stock solution further test concentrations were prepared for achieving test concentrations of 6.25mg/L, 12.5mg/L, 25mg/L, 50mg/L, 100mg/L, respectively.
- Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: Zebra Fish
- Strain: Danio rerio
- Length at study initiation (length definition, mean, range and SD): average 3.65 cm
- Weight at study initiation (mean and range, SD): average 0.332 g
-Housing:The fishes were kept in a static tank in tap water passed through reverse osmosis system, under natural conditions along with proper feed and aeration.
-Duration of housing: 15 days
-Photoperiod: 12 hours light and 12 hours darkness
-Diet : Standard brand feed, once daily
-Acclimatization: seven days
-feeding frequency: Once in a day - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Hardness:
- 141.4 mg of CaCO3
- Test temperature:
- 23°C
- pH:
- 7.07
- Dissolved oxygen:
- 7 to 7.2
- Nominal and measured concentrations:
- Nominal concentrations: 6.25 mg/L, 12.5 mg/L, 25mg/L, 50mg/L, 100 mg/L, respectively
- Details on test conditions:
- TEST SYSTEM
- Test vessel: Aquaria
- Material, size, headspace, fill volume: 5 liters of PP aquarium filled with 2 liter of water
- Aeration: Aeration in test vessels was provided 1 day before the start of experiment
- No. of organisms per vessel: 8 fishes
OTHER TEST CONDITIONS
- Photoperiod: 12 hours light and 12 hours darkness
- Reference substance (positive control):
- no
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 12.5 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: Other details not known
- Duration:
- 96 h
- Dose descriptor:
- LC0
- Effect conc.:
- 6.25 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: No effects were observed
- Sublethal observations / clinical signs:
Table 1: Mortality and symptoms:
NominalConcentration
(mg/l)
Number of fish
Mortality (cumulated) after
3 h
6 h
24h
48h
72h
96h
V1
V2
V1
V2
V1
V2
V1
V2
V1
V2
V1
V2
0 (control)
4
4
-
-
-
-
-
-
-
-
-
-
-
-
6.25
4
4
-
-
-
-
-
-
-
-
-
-
-
-
12.5
4
4
-
-
3
1
3
1
3
1
3
1
3
1
25
4
4
-
-
4
4
4
4
4
4
4
4
4
4
50
4
4
4
4
4
4
4
4
4
4
4
4
4
4
100
4
4
4
4
4
4
4
4
4
4
4
4
4
4
Table 2: Visible Symptoms:
NominalConcentration
(mg/l)
Number of fish
Symptoms after
3 h
6 h
24h
48h
72h
96h
V1
V2
V1
V2
V1
V2
V1
V2
V1
V2
V1
V2
0 (control)
4
4
NS4
NS4
NS4
NS4
NS4
NS4
NS4
NS4
NS4
NS4
NS4
NS4
6.25
4
4
NS4
NS4
NS4
NS4
NS4
NS4
NS4
NS4
NS4
NS4
NS4
NS4
12.5
4
4
NS4
NS4
C3NS1
C2NS2
NS1
NS3
NS1
NS3
NS1
NS3
NS1
NS3
25
4
4
NS4
C2NS2
-
-
-
-
-
-
-
-
-
-
50
4
4
-
-
-
-
-
-
-
-
-
-
-
-
100
4
4
-
-
-
-
-
-
-
-
-
-
-
-
Explanation of symptoms:
A:apathy
N:Narcotic-like state
C:Swimming near water surface
M: Slow movements compared to control
NS:No abnormal symptoms
S:Surfacing behaviour
L:Loss of equilibrium
SM:Shimming movement
H1:Hyperactivity
H2:Hypo activity
B:Bending behavior
F:Fin rot
IS:Invert Swimming
SB:Swimming behaviour
RF:Respiratory Function
P:Pigmentation
Table 3: pH and oxygen content:
NominalConcentration
(mg/l)
Number of fish
pH readings after
24h
48h
72h
96h
V1
V2
V1
V2
V1
V2
V1
V2
0 (control)
4
4
8.11
8.12
7.89
7.84
7.84
7.89
8.08
8.10
6.25
4
4
8.23
8.24
7.71
7.74
7.64
7.55
8.17
8.21
12.5
4
4
8.14
8.18
7.92
7.97
7.93
7.95
8.22
8.26
25
4
4
-
-
-
-
-
-
-
-
50
4
4
-
-
-
-
-
-
-
-
100
4
4
-
-
-
-
-
-
-
-
NominalConcentration
(mg/l)
Number of fish
Oxygen content (mg/L) after
24h
48h
72h
96h
V1
V2
V1
V2
V1
V2
V1
V2
0 (control)
4
4
7.0
7.1
7.0
7.1
7.1
7.1
7.0
7.0
6.25
4
4
7.1
7.1
7.1
7.1
7.0
7.0
7.0
7.0
12.5
4
4
7.2
7.1
7.1
7.0
7.0
7.0
7.0
7.0
25
4
4
-
-
-
-
-
-
-
-
50
4
4
-
-
-
-
-
-
-
-
100
4
4
-
-
-
-
-
-
-
-
Table 4: Test temperature
NominalConcentration
(mg/l)
Number of fish
Temperature (°C) after
24h
48h
72h
96h
V1
V2
V1
V2
V1
V2
V1
V2
0 (control)
4
4
23
23
23
23
23
23
23
23
6.25
4
4
23
23
23
23
23
23
23
23
12.5
4
4
23
23
23
23
23
23
23
23
25
4
4
-
-
-
-
-
-
-
-
50
4
4
-
-
-
-
-
-
-
-
100
4
4
-
-
-
-
-
-
-
-
- Validity criteria fulfilled:
- yes
- Conclusions:
- Based on nominal concentrations, experimental median lethal Concentrations [LC-50 (96 h)] for test chemical on Zebra Fish Danio rerio was determine to be 12.5 mg/l.
- Executive summary:
The acute study was designed to access the toxic effects of the test compound on the fishes. Test conducted in accordance with OECD Guideline 203 (Fish, Acute Toxicity Test). Zebra fish (Danio rerio) was used as a test organism. In house solubility was observed to be 281.985 mg/L. Thus the stock solution prepared as 2g /4 liter, with the concentration of 500 mg/L and was kept for 4 hours stirring. After the completion of stirring, the sample was run through HPLC system for getting the actual water solubility of the test substance. The actual solubility obtained was 122.66 mg/L. From this stock solution further test concentrations were prepared for achieving test concentrations of 6.25mg/L, 12.5mg/L, 25mg/L, 50mg/L, 100mg/L, respectively. Aquaria containing 4 liters of potable water (passed through reverse osmosis system) were loaded with 8 fishes each. A static procedure was used for the study. Effects on the mortality rate of fishes was calculated and were observed in the interval of 24, 48, 72 and 96 hours. Based on nominal concentrations, experimental median lethal Concentrations [LC-50 (96 h)] for test chemical on Zebra Fish Danio rerio was determine to be 12.5 mg/l. Thus on the basis of LC50 value, test chemical consider to be toxic and classified in aquatic chronic category 3 as per the CLP classification criteria, but as the chemical was readily biodegradable in water, hence chemical can be consider to be nontoxic and not classified as per the CLP classification criteria.
Reference
Description of key information
The acute study was designed to access the toxic effects of the test compound on the fishes. Test conducted in accordance with OECD Guideline 203 (Fish, Acute Toxicity Test). Zebra fish (Danio rerio) was used as a test organism. In house solubility was observed to be 281.985 mg/L. Thus the stock solution prepared as 2g /4 liter, with the concentration of 500 mg/L and was kept for 4 hours stirring. After the completion of stirring, the sample was run through HPLC system for getting the actual water solubility of the test substance. The actual solubility obtained was 122.66 mg/L. From this stock solution further test concentrations were prepared for achieving test concentrations of 6.25mg/L, 12.5mg/L, 25mg/L, 50mg/L, 100mg/L, respectively. Aquaria containing 4 liters of potable water (passed through reverse osmosis system) were loaded with 8 fishes each. A static procedure was used for the study. Effects on the mortality rate of fishes was calculated and were observed in the interval of 24, 48, 72 and 96 hours. Based on nominal concentrations, experimental median lethal Concentrations [LC-50 (96 h)] for test chemical on Zebra Fish Danio rerio was determined to be 12.5 mg/l. Thus on the basis of LC50 value, test chemical consider to be toxic and classified in aquatic chronic category 3 as per the CLP classification criteria, but as the chemical was readily biodegradable in water, hence chemical can be consider to be nontoxic and not classified as per the CLP classification criteria.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 12.5 mg/L
Additional information
Following different studies includes experimental study for the test chemical and read-across analogues which is extracted by using mechanistic approach and functionally and structurally similar to the target chemical to observe the short-term toxicity of test chemical to fishes.
The acute study was designed to access the toxic effects of the test compound on the fishes. Test conducted in accordance with OECD Guideline 203 (Fish, Acute Toxicity Test). Zebra fish (Danio rerio) was used as a test organism. In house solubility was observed to be 281.985 mg/L. Thus the stock solution prepared as 2g /4 liter, with the concentration of 500 mg/L and was kept for 4 hours stirring. After the completion of stirring, the sample was run through HPLC system for getting the actual water solubility of the test substance. The actual solubility obtained was 122.66 mg/L. From this stock solution further test concentrations were prepared for achieving test concentrations of 6.25mg/L, 12.5mg/L, 25mg/L, 50mg/L, 100mg/L, respectively. Aquaria containing 4 liters of potable water (passed through reverse osmosis system) were loaded with 8 fishes each. A static procedure was used for the study. Effects on the mortality rate of fishes was calculated and were observed in the interval of 24, 48, 72 and 96 hours. Based on nominal concentrations, experimental median lethal Concentrations [LC-50 (96 h)] for test chemical on Zebra Fish Danio rerio was determined to be 12.5 mg/l. Thus on the basis of LC50 value, test chemical consider to be toxic and classified in aquatic chronic category 3 as per the CLP classification criteria, but as the chemical was readily biodegradable in water, hence chemical can be consider to be nontoxic and not classified as per the CLP classification criteria.
Above study further supported by the second study from experimental source. This study was designed to access the toxic effects of the test chemical on the fishes. Test conducted in accordance with OECD Guideline 203 (Fish, Acute Toxicity Test). Zebra fish (Danio rerio) was used as a test organism. The stock solution was prepared by dissolving 1ml of the test substance in 1 liter of potable water (passed through reverse osmosis system) with 24 hrs of continuous stirring. From this stock solution, further test concentration was prepared for achieving test concentrations of 6.25 mg/L, 12.5 mg/L, 25 mg/L, 50 mg/L & 100 mg/L, respectively. Aquaria containing 4 liters of potable water (passed through reverse osmosis system) were loaded with 8 fishes each. A static procedure was used for the study. Effects on the mortality rate of fishes was calculated and were observed in the interval of 24, 48, 72 and 96 hours. The median lethal concentration (LC50) value of test chemical on Danio rerio in a 96 hours study on the basis of mortality effect was determined to be >12.5 mg/L. As 100 % mortality was observed at the concentration of 25 mg/l, thus on that basis, chemical consider to be toxic and classified in aquatic chronic category 3 as per the CLP classification criteria, but as the chemical was readily biodegradable in water, thus chemical consider to be nontoxic and not classified as per the CLP classification criteria.
Similar short term fish toxicity was conducted for 96 hrs for assessing the effect of test chemical. The study was performed following the OECD Guideline 203 (Fish, Acute Toxicity Test) under flow through conditions. Oryzias latipes (Japanese Medaka) of 28 -43 days old and 18 -71 mg weight obtained from the Environmental Research Laboratory-Duluth (ERL-D) culture unit was used as a test organism. Test fishes were nurtured in tank at 25°C and fed with live Biomaine brand brine shrimp. Before 24 hr or during the study, test organism was not fed. 5 different concentrations of test chemical along with the control were taken for the study. Stock solutions of test chemical was prepared by dissolving the test chemical in Lake Superior water, using a high speed stirrer. Stock solutions were then transferred to a glass stock bottle inside the vented diluter enclosure using Teflon tubing and air pressure. During each test, a predetermined volume (ml/min) of stock solution was continuously pumped from the stock bottle into the mixing cell of the diluter system. Test chemical concentrations were verified analytically and analysis was carried out bya Hewlett Packard 5730A gas chromatograph (GC) equipped with a flame ionization detector (FID) linked to an HP 3350 lab automation system. All test analyses were accomplished using direct aqueous injection. GC column consists of a wall-coated open tubular silica column, 0.53 mm I.D. x 15 cm, with a 2.5 µ phase of bonded polyethlene glycol at isothermal oven temperature of 85, 120 and 110°C, respectively. Total 20 fishes/conc (10 organisms/replicate) were exposed to test chemical in a2.0 lit glass aquaria tank.2.0 l glass aquaria tank has a dimension of 18.5 X 14.0 X 13.0 cm deep. It has a 8.6 cm standpipe which resulted in a total volume of 2.0 lit. Continuous-flow mini diluter exposure system with vented enclosures was used for the study. Flow rate during the study was 25 ml/min with 90% replacement times of 2.8 hr. Lake superior water was used.It was filtered before use through sand, a 50-micron filter; a 5-micron filter; and then exposed to ultraviolet light before heating to the test temperature of 25±1°C.The test vessels were placed in a room at a temperature of 25±1°C, pH 7.88 ± 0.18 (7.31 to 8.85), dissolve oxygen (D. O) 6.8 ± 0.7 (5.0 to 8.5), hardness of water 45.8 (38.0 to 52.0) mg/l as CaCO3, alkalinity 45.9 (35.0 to 58.5 mg/l) as CaCO3 and under a 16 hr photoperiod with a light intensity of 12 to 25 lumens provided by fluorescent lamps for 96 hrs. All experiments were performed in replicate.95% confidence intervals were calculated using the binomial tests. Dissolved oxygen (D.O.) was measured by a dissolved oxygen meter. pH was determined on one set of replicate tanks atleast once and often twice during the test. On the other hand, hardness and alkalinity determinations were done at a minimum on a control, one intermediate and one at high test concentration tank; it was carried out once or twice during the study. Mortality was noted after an exposure period of 96 hrs. No mortalities were observed in the control vessel, the dissolved oxygen concentration was evaluated to be ≥ 60% (i.e, reported as 82.3%) of the air saturation value in test vessels throughout the study period and analytical monitoring of test concentrations has been carried out, thus fulfilling the validity criteria of the study. As the test concentrations were maintained within ±20% of the initial measured concentrations throughout the study, all results will be reported in nominal concentrations. On the basis of the effect on mortality of the test organism Oryzias latipes (Japanese Medaka), the 96 hr LC50 was determined to be 4.0 mg/l (95% C. I. = 3.48 to 4.60 mg/l) (nominal concentration). Thus, test chemical was considered as toxic to fish and hence, considered to be classified in ‘aquatic chronic category 2’ as per the CLP classification criteria. But as the test chemical was readily biodegradable in water, thus chemical consider to be nontoxic and not classified as per the CLP classification criteria.
Thus, on the basis of above all studies and effects observation, it is concluded that the test chemical was nontoxic and not classified as per the CLP classification criteria.
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