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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-013-1 | CAS number: 102-20-5
- 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 using standard test guidelines
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- GLP compliance:
- no
- Analytical monitoring:
- no
- Vehicle:
- no
- Details on test solutions:
- Preparation of the test Solutions :
The stock solution was prepared by dissolving 15.56 mg of the test substance in 1 liters of potable water (passed through reverse osmosis system) and kept in sonicator for the sonication process of 30 min. From this stock solution required test concentration were prepared for achieving the test concentrations of 0.8 mg/L, 1.68 mg/L, 3.52 mg/L, 7.40 mg/L & 15.56 mg/L, respectively. - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
Body length: average 2.28 cm
Body weight: 0.115 g (average)
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
- Oxygen content: 7.5 (mg/l)
- pH: 7.1
- Water temperature : 28 °C
- Diet: Standard brand feed, once daily
Acclimatization: Fishes, to be used in the study, are kept in the test water for seven days immediately before testing under following conditions:
- Photoperiod: 12 hours light and 12 hours dark
- Temperature range: 21 °C
- DO range:7.2 mg/l
- Feeding: Daily once upto sixth day of accimatization
- Aeration: Continuous
- Mortality (%): During last 48 hours = < 5 % - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Hardness:
- 37.5 mg of CaCO3
- Test temperature:
- 23°C
- pH:
- 7.3
- Dissolved oxygen:
- 7.4 mg/L
- Nominal and measured concentrations:
- 0.8 mg/L, 1.68 mg/L, 3.52 mg/L, 7.40 mg/L & 15.56 mg/L
- Details on test conditions:
- Photoperiod :12 hours light and 12-hour darkness
Volume of water :4 liters
No. of animals per vessel :8 fishes
Test temperature :21°C
Adaptation :Test conditions corresponded to housing conditions
Test dates :Test started at : 23/05/2015
Date of experimental termination : 27/05/2015
Withdrawal of food :1 day before and during exposure
Aeration :Aeration in test vessels was provided during the experiment after 24 hours of the start of the experiment - Reference substance (positive control):
- not specified
- Duration:
- 96 h
- Dose descriptor:
- LC0
- Effect conc.:
- 7.4 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: highest loading at which no mortality was observed
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 11.47 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: LC50 was calculated through geometric mean based on LC0 and LC100 value.
- Duration:
- 96 h
- Dose descriptor:
- LC100
- Effect conc.:
- 15.55 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: lowest loading at which 100% mortality was observed
- Sublethal observations / clinical signs:
Table 1. Mortality and symptoms
NominalConcentration
(mg/l)
Number of fish
Mortality (cumulated) after
24h
48h
72h
96h
V1
V2
V1
V2
V1
V2
V1
V2
0 (control)
4
4
-
-
-
-
-
-
-
-
0.8
4
4
-
-
-
-
-
-
-
-
1.68
4
4
-
-
-
-
-
-
-
-
3.52
4
4
-
-
-
-
-
-
-
-
7.40
4
4
-
-
-
-
-
-
-
-
15.55
4
4
4
4
-
-
-
-
-
-
Visible Symptoms: Slow movement as compared to control
NominalConcentration
(mg/l)
Number of fish
Symptoms after
24h
48h
72h
96h
V1
V2
V1
V2
V1
V2
V1
V2
0 (control)
4
4
NS4
NS4
NS4
NS4
NS4
NS4
NS4
NS4
0.8
4
4
M4
M4
M4
M4
M4
M4
M4
M4
1.68
4
4
M4
M4
M4
M4
M4
M4
M4
M4
3.52
4
4
M4
M4
M4
M4
M4
M4
M4
M4
7.40
4
4
M4
M4
M4
M4
M4
M4
M4
M4
15.55
4
4
-
-
-
-
-
-
-
-
Explanation of symptoms:
A: apathy
N: narcotic-like state
C: swimming near water surface
D: swimming at the bottom of bowl
M: Slow movements compared to control
NS: No abnormal symptoms
Number behind symbol for symptom= number of affected fish
Table 2. 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
6.5
6.6
6.5
6.7
7.2
7.2
7.2
7.1
0.8
4
4
6.5
6.5
7.1
7.1
7.2
7.2
7.3
7.3
1.68
4
4
6.7
6.7
7.2
7.2
7.1
7.1
7.1
7.1
3.52
4
4
6.3
6.3
7.1
7.1
7.0
7.0
7.0
7.0
7.40
4
4
6.5
6.5
7.2
7.2
7.1
7.1
7.1
7.1
15.55
4
4
6.5
6.5
-
-
-
-
-
-
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
7.1
7.1
7.1
7.0
6.9
6.9
6.9
6.8
0.8
4
4
7.1
7.0
7.1
7.0
6.9
6.9
6.8
6.8
1.68
4
4
7.1
7.0
7.2
7.1
6.8
6.7
6.7
6.7
3.52
4
4
7.1
7.0
7.1
7.0
6.9
6.9
6.8
6.8
7.40
4
4
7.1
7.0
7.2
7.1
6.8
6.7
6.7
6.7
15.55
4
4
7.1
7.1
-
-
-
-
-
-
Table 3. 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
21
21
21
21
21
21
21
21
0.8
4
4
21
21
21
21
21
21
21
21
1.68
4
4
21
21
21
21
21
21
21
21
3.52
4
4
21
21
21
21
21
21
21
21
7.40
4
4
21
21
21
21
21
21
21
21
15.55
4
4
21
21
-
-
-
-
-
-
- Validity criteria fulfilled:
- yes
- Conclusions:
- Based on nominal concentrations, experimental median lethal Concentrations [LC-50 (96 h)] of test material on Zebra fish (Danio rerio) was determined to be 11.47 mg/l calculated through geometric mean based on LC0 and LC100 value.
- Executive summary:
Principle of this study was to determine the effect of test chemical on the mortality rate of 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 15.56 mg of the test substance in 1 liters of potable water (passed through reverse osmosis system) and kept in sonicator for the sonication process of 30 min. From this stock solution required test concentration were prepared for achieving the test concentrations of 0.8 mg/L, 1.68 mg/L, 3.52 mg/L, 7.40 mg/L & 15.56 mg/L, respectively and Zebra fish (Danio rerio) were exposed to these concentration for 96 hours. Test performed under the static system. Effects on the mortality rate of fishes was calculated and were observed in the interval of 24, 48, 72 and 96 hours. The fishes were moving slowly as compared to control. No mortalities were observed in the control aquaria. Based on nominal concentrations, experimental median lethal Concentrations [LC-50 (96 h)] of test material on Zebra fish (Danio rerio) was determined to be 11.47 mg/l calculated through geometric mean based on LC0 and LC100 value. Thus based on the LC50 value, it can be concluded that the test chemical was toxic to fish and can be classified in "aquatic chronic 3"category under CLP regulation.
Reference
Description of key information
Principle of this study was to determine the effect of test chemical on the mortality rate of 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 15.56 mg of the test substance in 1 liters of potable water (passed through reverse osmosis system) and kept in sonicator for the sonication process of 30 min. From this stock solution required test concentration were prepared for achieving the test concentrations of 0.8 mg/L, 1.68 mg/L, 3.52 mg/L, 7.40 mg/L & 15.56 mg/L, respectively and Zebra fish (Danio rerio) were exposed to these concentration for 96 hours. Test performed under the static system. Effects on the mortality rate of fishes was calculated and were observed in the interval of 24, 48, 72 and 96 hours. The fishes were moving slowly as compared to control. No mortalities were observed in the control aquaria. Based on nominal concentrations, experimental median lethal Concentrations [LC-50 (96 h)] of test material on Zebra fish (Danio rerio) was determined to be 11.47 mg/l calculated through geometric mean based on LC0 and LC100 value. Thus based on the LC50 value, it can be concluded that the test chemical was toxic to fish and can be classified in "aquatic chronic 3"category under CLP regulation.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Dose descriptor:
- LC50
- Effect concentration:
- 11.47 mg/L
Additional information
Data available for the test chemical and structurally and functionally similar read across chemicals has been reviewed to determine the toxicity of the test chemical on fishes. The studies are as mentioned below:
Principle of this study was to determine the effect of test chemical on the mortality rate of 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 15.56 mg of the test substance in 1 liters of potable water (passed through reverse osmosis system) and kept in sonicator for the sonication process of 30 min. From this stock solution required test concentration were prepared for achieving the test concentrations of 0.8 mg/L, 1.68 mg/L, 3.52 mg/L, 7.40 mg/L & 15.56 mg/L, respectively and Zebra fish (Danio rerio) were exposed to these concentration for 96 hours. Test performed under the static system. Effects on the mortality rate of fishes was calculated and were observed in the interval of 24, 48, 72 and 96 hours. The fishes were moving slowly as compared to control. No mortalities were observed in the control aquaria. Based on nominal concentrations, experimental median lethal Concentrations [LC-50 (96 h)] of test material on Zebra fish (Danio rerio) was determined to be 11.47 mg/l calculated through geometric mean based on LC0 and LC100 value. Thus based on the LC50 value, it can be concluded that the test chemical was toxic to fish and can be classified in "aquatic chronic 3"category under CLP regulation.
Above study further supported by the second study from experimental sources. This 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. 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 determine 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.
Similar an acute toxicity test was conducted for 96 hrs for assessing the effect of test chemical on Zebra fish (Danio rerio). The test was performed in accordance to OECD guideline No. 203 “Fish Acute Toxicity Test”. Zebra fish (Danio rerio) of average length of 2.7 cm and average weight of 0.19 g was used as a test organism for the study. Test fishes were kept in a static tank in tap water passed through reverse osmosis system, under natural conditions along with proper feed and aeration. During the housing period, test fishes were fed once daily with standard brand fed. The test conditions during the housing of the test organisms were oxygen content of 8.8 mg/l, pH 7.5, water temperature 22°C and under a photoperiod of 16:8 hr light: dark conditions, respectively. The test chemical was prepared by dissolving 5 gm of test chemical in 5 lit of potable water (passed through reverse osmosis system). After stirring, the stock solution was filtered and analytically detected & the concentration was found to be 236.34 mg/l. The remaining test solutions were prepared by dilution from the stock solution. Test chemical concentrations were analytically determined by UV-VIS spectrophotometer. Test chemical concentrations used for the study were 0, 6.25, 12.5, 50 and 100 mg/l, respectively. Total 7 fishes were exposed to test chemical in a 4 lit Polypropylene (PP) fish tank containing 4000 ml of potable water. The test vessels were placed in a room at a temperature of 21 -22°C, pH of control at 0 and 96 hr was 7.8 & 7.9 and DO of control at 0 and 96 hr was 7.9 & 4.8 mg/l and under a photoperiod of 16:8 hr light: dark conditions, respectively. Aeration in test vessels was provided 1 day before the start of the experiment. Mortality in the control was 0%. The dissolved oxygen concentration remained above 60% of the air saturation value throughout the exposure period. Thus, fulfilling the validity criterion. As the concentration of the test chemical being tested has been satisfactorily maintained within ± 20 % of the nominal concentration throughout the test. Therefore, the analysis of the results was based on nominal concentration. On the basis of effect of test chemical on mortality of the test organism, the 96 hr median lethal concentration [LC50 (96 h)] for test chemical on Danio rerio (Zebra Fish) was determined to be in the range of > 25 to < 50 mg/L. Thus, test chemical was considered as toxic to aquatic fishes and hence, considered to be classified in 'aquatic chronic category 3' as per the CLP classification criteria.
Thus based on the above all studies and effects observations, it is concluded that the test chemical was toxic and can be consider to be classified in aquatic chronic category 3 as per the CLP classification criteria.
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.