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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 fish
Administrative data
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 May to 19 May 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to OECD test guidance in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Details on test material:
- Reactive Red F08-0146
Constituent 1
- Specific details on test material used for the study:
- Details on properties of test surrogate or analogue material (migrated information):
Not applicable.
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- The actual concentrations of nominal concentration of 120 mg/L test substance solution and blank control was measured at 0h, 96h and 24h, 48h, 72h (after and before the renewal) after the start of the test by a High Performance Liquid Chromatography (HPLC).
The test solution was centrifugal by 12000r/min for 3min, supernatant was collected, this procedure was repeated twice. The supernatant diluted 4 times was analyzed immediately, otherwise the sample stored at 4℃ until analyzed.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- Test water
The chlorine of drinking water was removed by aeration.
Hardness: 112mg/L (expressed as CaCO3)
pH: 7.81
Preparation of test solution
0.600g test substance was dissolved in a certain amount test water with ultrasonic treatment for 3 min , then the solution was diluted with the test water to 5000mL and was stirred with a magnetic stirrer for 1h, nominal concentration of 120mg /L test solution (101 mg/L calculated based on 84.10% purity of main constituent) was obtained.
Test organisms
- Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- Reason for selection of species
The test species is recommended by "The Guidelines for the Testing of Chemicals".
Supplier: Kang Da Breeding Farm.
Acclimation
Zebra fish (Brachydanio rerio) was obtained on April 26, 2011.
Before the start of the test, Zebra fish (Brachydanio rerio) were acclimated for 17 days by flow-through under the same conditions of water quality (Dechlorinated tap water), temperature (23℃±2℃), light and dark period (14h light / 10h dark). The dissolved oxygen concentration during acclimation was kept at least 80 % of the air saturation value. The test fish were fed daily until 24 hours before the start of the test.
The mortality was 0% during 7 days before the start of the test, which met the requirement.
Size:
10 fish were randomly selected and measured on May 18, 2011. The average and standard deviation were 26.84 mm±1.97 mm at total length and the average and standard deviation were 0.295 g±0.117 g at weight.
Allocation to the test groups
Zebra fish (Brachydanio rerio) were allocated at random to each test group within 30 minutes.
Study design
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Post exposure observation period:
- None
Test conditions
- Hardness:
- 112mg/L (expressed as CaCO3)
- Test temperature:
- 24.1℃ to 24.8℃
- pH:
- 7.55 to 8.4
- Dissolved oxygen:
- 64% to 95%. The dissolved oxygen concentrations were kept at least 60 percent of the air saturation value, which met the criterion for the validity of the test.
- Salinity:
- Not applicable.
- Nominal and measured concentrations:
- Nominal concentration of 120 mg/L of test substance solution (101 mg/L calculated based on 84.10% purity of main constituent).
- Details on test conditions:
- Test conditions:
Conditions of exposure
Type of test: Semi-static test (renewal at every 24h)
Exposure duration: 96hr
Test concentration: Nominal concentration of 120 mg/L of test substance solution (101 mg/L calculated based on 84.10% purity of main constituent).
Control: A blank control (test water without test substance) was run in parallel to the test concentration.
Replicate: No replicate
Number of fish: 10 fish / test group
Volume of test solution: 3L / test vessel
Conditions of test environment:
The test was performed without adjustment of pH.
Light: Artificial light of white fluorescent lamp, 14h light / 10h darkness
Feeding: The fish were not fed during the exposure. - Reference substance (positive control):
- no
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 120 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- > 120 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- Mortality
Cumulative mortality of each group at 24h, 48h, 72h and 96h after the start of the test are shown in Table 1. below.
The cumulative mortality of blank control was 0% at the end of the test, which met the criterion for the validity of the test .
Observed abnormal response
The abnormal response observed during the test are shown in Table 2 below.
No abnormal response was observed in blank control and test substance group.
Measurement of temperature, pH and dissolved oxygen of test solution
The temperature, pH and dissolved oxygen of each test group at 0h, 96h and 24h, 48h, 72h (after and before the renewal) after the start of the test are shown in Tables 3 - 5 below.
During the test, the measurement values of pH, temperature and dissolved oxygen ranged from 7.55 to 8.40, 24.1℃ to 24.8℃, and 64% to 95%, respectively. The dissolved oxygen concentrations were kept at least 60 percent of the air saturation value, which met the criterion for the validity of the test.
Concentration of main constituent in test solution
The measured concentrations of main content in blank control was all < 0.01720mg/L (LOD) at 0h, 96h and 24h, 48h, 72h (after and before the renewal) after the start of the test.
The measured concentrations of main content in nominal concentration of 120 mg/L test substance solutions at 0h, 96h and 24h, 48h, 72h (after and before the renewal) after the start of the test were 59.56 mg/L (0h), 42.24 mg/L (24h old), 71.72 mg/L (24h new), 42.04 mg/L (48h old), 82.52 mg/L (48h new), 44.44 mg/L (72h old), 77.12 mg/L (72h new) and 41.64 mg/L (96h). During renewing the test solution at 24 hour intervals, the actual concentration of main content cannot be maintained within 80%-120% of the nominal concentration of main content (86.4mg/L).
Median Lethal Concentration (LC50)
The LC50 at 24h, 48h, 72h and 96h after the start of the test are shown in Table 6 below.
At the end of the test, the cumulative mortality of nominal concentration of 120 mg/L test substance group was 0%, so the 96h-LC50 of test substance to Zebra fish (Brachydanio rerio) was greater than nominal concentration of 120 mg/L test substance solution (64.76 mg/L calculated based on the geometric mean of actual concentration of main constituent). - Results with reference substance (positive control):
- Not applicable.
- Reported statistics and error estimates:
- None.
Any other information on results incl. tables
- Sublethal observations / clinical signs:
Table 1 Cumulative mortality (%)
Nominal concentration
(mg/L)
Number of test fish
Cumulative mortality(%)
24h
48h
72h
96h
Blank control
10
0
0
0
0
120
10
0
0
0
0
Table 2 Observed abnormal response
Nominal concentration
(mg/L)
Result of observation
(Left column: Number of affected fish / Total survival number, Right column: Symptom detail)
24h
48h
72h
96h
Blank control
0/10
N
0/10
N
0/10
N
0/10
N
120
0/10
N
0/10
N
0/10
N
0/10
N
Note: N — Normal
Table 3 Temperature of test solutions(℃)
Nominal concentration
(mg/L)
0h
24h
48h
72h
96h
old
new
old
new
old
new
Blank control
24.1
24.1
24.1
24.4
24.4
24.2
24.7
24.3
120
24.1
24.3
24.2
24.6
24.8
24.2
24.5
24.3
Table 4 pH of test solutions
Nominal concentration
(mg/L)
0h
24h
48h
72h
96h
old
new
old
new
old
new
Blank control
8.40
8.04
7.97
7.55
8.36
7.96
8.36
7.80
120
8.29
7.80
7.81
7.78
8.15
7.78
8.17
7.83
Table 5 Dissolved oxygen concentration of test solutions (%)
Nominal concentration
(mg/L)
0h
24h
48h
72h
96h
old
new
old
new
old
new
Blank control
94
80
93
74
89
87
91
85
120
93
64
95
79
93
82
94
81
Table 6 Median lethal concentration (LC50) and the 95% confidence limits
Exposure duration
LC50(mg/L)1
95% confidence limits
24 h
> 64.76
—
48 h
> 64.76
—
72 h
>64.76
—
96 h
>64.76
—
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- Under the conditions of the test, the 96h-LC50 of test substance to Zebra fish (Brachydanio rerio) was greater than nominal concentration of 120 mg/L test substance solution (64.76 mg/L calculated based on the geometric mean of actual concentration of main constituent). 96h Lowest Observed Effect Concentration (LOEC) was greater than nominal concentration of 120 mg/L test substance solution (64.76 mg/L calculated based on the geometric mean of actual concentration of main constituent), 96h No Observed Effect Concentration (NOEC) was nominal concentration of 120 mg/L test substance solution (64.76 mg/L calculated based on the geometric mean of actual concentration of main constituent).
- Executive summary:
An acute fish toxicity test of Reactive Red F08 -0146 was conducted according to OECD Guidelines for the Testing of Chemicals, 203 Fish Acute Toxicity Test. Paris: OECD, Adopted 17 July 1992.
Under the conditions of the test, the 96h-LC50 of test substance to Zebra fish (Brachydanio rerio) was greater than nominal concentration of 120 mg/L test substance solution (64.76 mg/L calculated based on the geometric mean of actual concentration of main content). The 96h Lowest Observed Effect Concentration (LOEC) was greater than nominal concentration of 120 mg/L test substance solution (64.76 mg/L calculated based on the geometric mean of actual concentration of main content), the 96h No Observed Effect Concentration (NOEC) was nominal concentration of 120 mg/L test substance solution (64.76 mg/L calculated based on the geometric mean of actual concentration of the main constituent).
The nominal values for the LC50 and the NOEC have been used for to determine classification for the following reasons:
Reactive dyes do not historically cause toxicity to fish and no effects on fish were observed in this study.
The lower than expected geometric mean value noted in this study is probably due to hydrolysis of Reactive Red F08-0146 under test conditions therefore it is not an accurate value. The results of the hydrolysis study included in Chapter 5.1.2 of this dossier shows that Reactive Red F08-0146 undergoes significant hydrolysis at neutral pH. The results of this study indicate that the hydrolysis products of the test substance do not appear to harm fish.
The test substance is not classified based on the 96h LC50 > 120 mg/L (nominal concentration).
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.
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