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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 fish
Administrative data
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 March 2011 to 19 April 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted in accordance with OECD Guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: State Environmental Protection Administration of China. The Guidelines for the Testing of Chemicals, 203 Fish Acute Toxicity Test. China Environmental Science Press. 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: State Environmental Protection Administration of China. The Guidelines for the test of chemical (HJ/T 153-2004). Beijing: China Environmental Science Press.2004
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Details on test material:
- Name: Reactive Orange F08-0314
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:
- Nominal concentration of 195mg /L test solution (129 mg/L calculated based on 66% purity of main constituent)
The filtrate was analyzed immediately. Otherwise the samples were stored at 4℃ until analysis.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- 0.585g test substance was dissolved in a certain amount test water with ultrasonic treatment for 5 min. Then the solution was diluted with the test water to 3000mL, the nominal concentration of 195mg /L test solution (129 mg/L calculated based on 66% purity of main constituent) was obtained. The test solution was prepared and was used every day.
Test organisms
- Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- Species: Zebra fish (Brachydanio rerio)
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 January 25 2011. Before the start of the test, Zebra fish (Brachydanio rerio) were acclimated for 31 days by flow-through under the same conditions of water quality (Dechlorinated tap water), temperature (23°C±2°C), 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 0.8% during 7 days before the start of the test, which met the requirement.
Size: 10 fish were randomly selected and measured on March 1, 2011. The average and standard deviation were 24.76 mm±2.10 mm at total length and the average and standard deviation were 0.208 g±0.053 g at weight in the population from which the fish were selected.
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:
- Not applicable
Test conditions
- Hardness:
- 132mg/L (expressed as CaCO3)
- Test temperature:
- 21.2℃ to 24.7℃
- pH:
- 7.56 to 8.11
- Dissolved oxygen:
- 73% to 109%
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 195mg /L test solution (129 mg/L calculated based on 66% purity of main constituent).
The measured concentrations of main constituent in nominal concentration of 195 mg/L test substance solutions at 0h, 96h and 24h, 48h, 72h (after and before the renewal) after the start of the test were 106.3 mg/L (0h), 67.39 mg/L (24h old), 119.1 mg/L (24h new), 65.11 mg/L (48h old), 117.9 mg/L (48h new), 69.70 mg/L (72h old), 110.0 mg/L (72h new) and 72.80 mg/L (96h), which exceeded ±20% of the nominal concentration of main constituent (129 mg/L). - Details on test conditions:
- Conditions of exposure:
Type of test: Semi-static test (renewal at every 24h)
Exposure duration: 96h
Test concentration: Nominal concentration of 195 mg/L of test substance solution (129 mg/L calculated based on 66% purity of main constituent).
Control: A blank control (test water without test substance) was also 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:
Water temperature: 23.0℃±2.0℃
Dissolved oxygen concentration: The test solutions were not aerated during the exposure. The dissolved oxygen concentration in the test solutions during the test was kept at least 60 % of the air saturation value.
pH: 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.
Observation and measurements:
Observation of test organisms
Mortality and visible abnormality of the test fish were recorded at 24h, 48h, 72h and 96h after the start of the test during test period. The dead fish were removed as soon as they were found. A fish was considered dead if there was no visible movement (e.g. gill movements) and if touching of the caudal peduncle produced no reaction.
Measurement of temperature, pH and dissolved oxygen of test solution
The temperature, pH and dissolved oxygen of each test group were measured at 0h, 96h and 24h, 48h and 72h (before and after the renewal) after the start of the test. Measurements of pH were carried out with a portable pH meter. Measurements of temperature and dissolved oxygen were carried out with an oxygen meter.
Measurement of actual concentrations of main constituent.
The actual concentrations of main constituent of nominal concentration of 195 mg/L test solution was measured at 0h, 96h and 24h, 48h and 72h (before and after the renewal) after the start of the test by a High Performance Liquid Chromatography (HPLC).
Data process
Cumulative mortality of each group at 24h, 48h, 72h and 96h after the start of the test were calculated; The LC50 values at 24h, 48h, 72h and 96h after the start of the test were calculated by Binomial test;.
Quality assurance
(1) The mortalities of the controls were less than 10% at the end of the test.
(2) The dissolved oxygen concentration in the test solutions was kept at least 60 percent of the air saturation value throughout the test. - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
Results and discussion
Effect concentrations
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 133.6 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- The cumulative mortality of blank control was 0% at the end of the test, which met the criterion for the validity of the test.
No abnormal response was observed in blank control and test substance group. - Results with reference substance (positive control):
- The test result of Zebra fish (Brachydanio rerio) sensitivity test revealed that 24h-LC50 of the reference substance K2Cr2O7 was 274 mg/L with 95% confidence limits (L95) of 241mg/L - 311mg/L, within the range of 200 mg/L-400 mg/L.
- 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
195
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
195
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
24hold
24h new
48h old
48h new
72hold
72h new
96h
Blank control
23.2
24.7
23.5
22.9
21.9
22.3
21.4
22.0
195
23.5
24.6
23.0
22.8
21.2
22.1
21.5
21.9
Table 4 pH of test solutions
Nominal concentration
(mg/L)
0h
24h old
24h new
48h old
48h new
72h old
72h new
96h
Blank control
8.00
7.83
8.11
7.68
7.97
7.87
8.10
7.86
195
7.59
7.56
7.68
7.66
7.64
7.63
7.76
7.67
Table 5 Dissolved oxygen concentration of test solutions (%)
Nominal concentration
(mg/L)
0h
24h old
24h new
48h old
48h new
72h old
72h new
96h
Blank control
109
89
108
73
103
91
103
95
195
107
82
107
84
102
90
103
95
Table 6 Median lethal concentration (LC50) and the 95% confidence limits
Exposure duration
LC50(mg/L)1
95% confidence limits
24 h
>88.18
—
48 h
>88.18
—
72 h
>88.18
—
96 h
>88.18
—
Note: 1— Calculated based on geometric meanmeasured concentrations ofmain constituent.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- Under the conditions of the test, the 96h-LC50of test substance to Zebra fish (Brachydanio rerio) was greater than nominal concentration of 195 mg/L test substance solution (88.18 mg/L calculated based on the geometric mean of actual concentration of main constituent and 133.6 mg/L based on the geometric mean of the actual concentration of the test substance).The highest concentration causing 0% mortality at 96h (LC0) was nominal concentration of 195 mg/L test substance solution (88.18 mg/L calculated based on the geometric mean of actual concentration of main constituent and 133.6 mg/L based on the geometric mean of the actual concentration of the test substance), the lowest concentration causing 100% mortality at 96h (LC100) was greater than nominal concentration of 195 mg/L test substance solution (88.18 mg/L calculated based on the geometric mean of actual concentrationof main constituent and 133.6 mg/L based on the geometric mean of the actual concentration of the test substance).
- Executive summary:
The acute toxicity to fish of the substance, Reactive Yellow F01-0555, was evaluated in accordance with OECD Guideline 203.
Under the conditions of the test, the 96h-LC50of test substance to Zebra fish (Brachydanio rerio) was greater than nominal concentration of 195 mg/L test substance solution (88.18 mg/L calculated based on the geometric mean of actual concentration of main constituent and 133.6 mg/L based on the geometric mean of the actual concentration of the test substance).The highest concentration causing 0% mortality at 96h (LC0) was nominal concentration of 195 mg/L test substance solution (88.18 mg/L calculated based on the geometric mean of actual concentration of main constituent and 133.6 mg/L based on the geometric mean of the actual concentration of the test substance), the lowest concentration causing 100% mortality at 96h (LC100) was greater than nominal concentration of 195 mg/L test substance solution (88.18 mg/L calculated based on the geometric mean of actual concentrationof main constituent and 133.6 mg/L based on the geometric mean of the actual concentration of the test substance).
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.
Although ECHA is providing a lot of online material in your language, part of this page is only in English. More about ECHA’s multilingual practice.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
the-echa-website-uses-cookies
find-out-more-on how-we-use-cookies