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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 226-214-6 | CAS number: 5328-37-0
- 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:
- 2018-06-04 to 2018-06-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- 17 July 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Version / remarks:
- May 30, 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No. of test material: AD16081001
- Expiration date of the batch: 2019-08-09
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
- Stability under test conditions: Stable under ambient conditions - Analytical monitoring:
- yes
- Details on sampling:
- - Sampling method: five replicate samples (2 mL per replicate) were taken from the test solution (100 mg/L) and one from the control (2 mL per replicate) at the start and at the end of the test.
- Sample storage conditions before analysis: Analyzed immediately after sampling - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The ISO medium was prepared by adding 25 mL from each of four stock solutions to one litre deionised water. The test solution used in the test was prepared by mechanical dispersion without using of any solubilising agent.
- Controls: Negative control, only ISO Test Medium without the test item
- Evidence of undissolved material: No - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: Zebrafish
- Source: Akvárium Magazin Kft. (Pasaréti Gyula), 1222 Budapest, Dévény u. 36., Hungary
- Number of animals: 10 animals at each group (no replicates used)
- Age and size of animals: Juveniles; size within a range of 2.0 ± 1 cm
- Loading: The loading of the test aquaria did not exceed 1.0 g / L
- Sex: Both female and male (not separated)
- Animal health: Apparently healthy animals were used in the test
ACCLIMATION
Fish were held for at least 12 days before test initiation in the fish laboratory under the same conditions as used during the exposure period. During holding, fish were fed with appropriate, commercial diet for fish at least three times per week until 24 hours before the test started. The fish were not fed during the test. The health of the breeding was continuously monitored and any mortality or abnormal behaviour was recorded.
The mortalities were recorded for seven days immediately before the test and the following criteria were applied:
- Mortalities of greater than 10 per cent of population in seven days: Rejection of entire batch
- Mortalities of between 5 and 10 per cent of population: Acclimatisation continued for seven additional days
- Mortalities of less than 5 per cent of population: Acceptance of batch - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Post exposure observation period:
- No
- Hardness:
- 249 mg/L (as CaCO3)
- Test temperature:
- 22.6 – 23.5 °C
- pH:
- 7.07 – 7.87
- Dissolved oxygen:
- 62.8 – 96.3 % of the air saturation value at the temperature used
- Salinity:
- Not applicable
- Conductivity:
- Not specified
- Nominal and measured concentrations:
- Nominal concentration: 100 mg/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel: glass aquariums with 5 litre test liquid
- Aeration: test solutions were not aerated during the test
- No. of organisms per vessel: 10
- No. of vessels per concentration: 1
- No. of vessels per control: 1
TEST MEDIUM
- Preparation of dilution water: ISO Medium (according to guideline)
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light: 8 h dark
EFFECT PARAMETERS MEASURED: mortality, signs of intoxication
TEST CONCENTRATIONS
- Test concentrations in the main test: Based on the results of the non-GLP preliminary experiment the test item had no toxic effects on Zebrafish up to a concentration of 100 mg/L (limit concentration). Therefore, a limit test was performed using only the concentration of 100 mg/L. Concurrent control group ran.
- Pre-Experiment: A non-GLP preliminary experiment was carried out at 100 mg/L nominal concentration to check whether the test item had any toxic effects up to the limit concentration (i.e. 100 mg/L).
- Preparation of test solutions: The test solution used in the main test was prepared by mechanical dispersion without using of any solubilising agent. An amount of 0.5005 g test item was dissolved in 5000 mL dilution water (ISO Medium) to obtain the nominal concentration of 100 mg/L.
Untreated control ran parallel in the test. After the formulation procedure the test animals were immediately introduced into test solution. - Reference substance (positive control):
- no
- Remarks:
- not applicable
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- There were no mortalities or any sub-lethal effects observed in 10 fish in the control group or in 10 fish exposed to the 100 mg/L test concentration during the 96-h test period.
- Results with reference substance (positive control):
- Positive control not conducted.
- Reported statistics and error estimates:
- Since a limit test was performed (and mortality was not occurred), no statistical analysis was necessary. The LC0, LC50, NOEC, LOEC and the LC100 values were determined directly from the raw data.
- Sublethal observations / clinical signs:
Table 1: Cumulative Mortality Data
Test Group
Cumulative mortality
(initial population = 10 fish / test group)5h
24h
48h
72h
96h
Control
0
0
0
0
0
100 mg/L
0
0
0
0
0
Table 2: Measured and calculated Body Weight
Test Group
Measured weight
of 10 fish (g)Calculated mean
weight of 1 fish (g)Loading of testing aquarium
(g fish/L testing liquid)Control
2.01
0.201
0.40
100 mg/L
2.11
0.211
0.42
Table 3: Body Length of Test Animals
Test Group
Body length [cm]
Control
2.35
2.30
2.55
2.35
2.50
2.40
2.25
2.45
2.40
2.50
100 mg/L
2.45
2.40
2.45
2.40
2.45
2.45
2.30
2.35
2.35
2.45
Table 4: pH-values measured during the Experiment
Test Group
pH
0h
24h
48h
72h
96h
Control
7.87
7.75
7.61
7.66
7.82
100 mg/L
7.82
7.65
7.07
7.38
7.48
Table 5: Dissolved Oxygen Concentrations measured during the Experiment
Test Group
Dissolved Oxygen Concentration[%]
0h
24h
48h
72h
96h
Control
96.3
84.5
86.3
80.8
84.0
100 mg/L
95.8
78.8
67.8
65.1
62.8
Table 6: Temperatures measured during the Experiment
Test Group
Temperature[°C]
0h
24h
48h
72h
96h
Control
22.6
23.3
23.4
23.2
23.4
100 mg/L
22.8
23.4
23.5
23.4
23.5
Table 7: Concentration of Test Item measured in the Test Solutions
Nominal concentration mg/L Start (June 04, 2018) End (June 08, 2018) Concentration (mg/L) % of the nominal concentration Concentration (mg/L) % of the nominal concentration Control not detected - not detected - 100 105 105 89.8 90 106 106 88.7 89 110 110 88.5 88 107 107 88.3 88 104 104 87 87 Mean: 106 106 88.5 88 RSD: 2 2 1 1 - Validity criteria fulfilled:
- yes
- Conclusions:
- In a GLP-compliant Acute Toxicity Test with Danio rerio according to OECD guideline 203, EU-Method C.1 and EPA OPPTS 850.1075, the 96-hour LC50 of the test item was determined to be > 100 mg/L (nominal).
- Executive summary:
The acute toxicity of the test item to zebrafish (Danio rerio) was assessed in a 96-hour limit test under GLP conditions according to OECD guideline 203, EU-Method C.1 and EPA OPPTS 850.1075. Ten fish were exposed to aqueous test media containing the test item at the concentration of 100 mg/L. In addition, a negative control (ISO medium only) with 10 animals was performed. No replicates both for the limit concentration and the negative control were used. Fish were observed at approximately 5, 24, 48, 72 and 96 hours after start of the test for signs of intoxication and mortality. Measurements of pH, dissolved oxygen concentration and temperature were carried out daily. Concentrations of the test item were determined at the start and the end of the test using the LC/MS/MS method.The measured concentrations of the test item were in the range of 104 – 110 % of the nominal concentration at the start of the test and were in the range of 87– 90 % of the nominal concentration at the end of the test. Therefore, biological results are based on nominal test item concentrations and endpoints. As a limit test was performed, effect values were determined directly from the raw data. In result, the test item had no toxic effect on Danio rerio at 100 mg/L concentration (i.e. limit test concentration). Accordingly, the 96-h LC50 value was determined to be > 100 mg/L. The 96-h NOEC was determined to be 100 mg/L. All validity criteria of the guidelines were met.
Reference
Description of key information
In an Acute Toxicity Test with Danio rerio according to OECD TG 203 the 96-hour LC50 of the substance was determined to be > 100 mg/L.
Key value for chemical safety assessment
Additional information
The acute toxicity of the test item to zebrafish (Danio rerio) was assessed in a 96-hour limit test under GLP conditions according to OECD guideline 203, EU-Method C.1 and EPA OPPTS 850.1075. Ten fish were exposed to aqueous test media containing the test item at the concentration of 100 mg/L. In addition, a negative control (ISO medium only) with 10 animals was performed. No replicates both for the limit concentration and the negative control were used. Fish were observed at approximately 5, 24, 48, 72 and 96 hours after start of the test for signs of intoxication and mortality. Measurements of pH, dissolved oxygen concentration and temperature were carried out daily. Concentrations of the test item were determined at the start and the end of the test using the LC/MS/MS method.The measured concentrations of the test item were in the range of 104 – 110 % of the nominal concentration at the start of the test and were in the range of 87– 90 % of the nominal concentration at the end of the test. Therefore, biological results are based on nominal test item concentrationsand endpoints. As a limit test was performed, effect values were determined directly from the raw data. In result, the test itemhad no toxic effect on Danio rerio at 100 mg/L concentration (i.e. limit test concentration).Accordingly, the 96-h LC50 value was determined to be > 100 mg/L. The 96-h NOEC was determined to be 100 mg/L. All validity criteria of the guidelines were met.
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.