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Diss Factsheets
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EC number: 253-775-4 | CAS number: 38083-17-9
- 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
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Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- fish early-life stage toxicity
- Remarks:
- Integrated with the Fish Sexual Development Test
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2020-June to 2021-September
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)
- Version / remarks:
- 2013
- Deviations:
- yes
- Remarks:
- Due to animal wellfare reasons a OECD 234 was designed such that the endpoints required by an OECD 210 could be evaluated
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Remarks:
- LC-MS/MS
- Details on sampling:
- Samples (8 mL) of test media from the control and each test concentration were taken for analysis weekly throughout the duration of the test. A single replicate was sampled on each occasion with alternate replicates sampled each time with the exception of Day 0 (start of exposure) and the end of the test when each replicate was sampled.
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: stock solutions and dilution water were pumped by means of a peristaltic pump through an in-line mixer. The media were then split into the replicate test vessels.
- Controls: dilution water without test item
- Test concentration separation factor: 3.2
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): no - Test organisms (species):
- Oryzias latipes
- Details on test organisms:
- TEST ORGANISM
- Common name: Japanese medaka
- Source: in-house laboratory breeded
METHOD FOR PREPARATION AND COLLECTION OF FERTILIZED EGGS
- Method of collection of fertilised eggs: The eggs were collected from the breeding groups and gently rolled to remove filaments.
POST-HATCH FEEDING
- Start date: 13th day
- Type/source of feed: Tetramin® flake food and/or live brine shrimp (Artemia) nauplii, (ca 24 or 48 hours old), depending on the size of the fish.
- Frequency of feeding: 1 to 3 times per day - Test type:
- flow-through
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 30 d
- Hardness:
- In Control: 40-83 mg/L as CaCO3;
In treatments: 52-87 mg/L as CaCO3 - Test temperature:
- 25 ± 2ºC
- pH:
- see details on test conditions
- Dissolved oxygen:
- > 60% air saturation value
- Salinity:
- see details on test conditions
- Conductivity:
- see details on test conditions
- Nominal and measured concentrations:
- Nominal Concentrations: 0.0050, 0.016, 0.050, 0.16 and 0.50 mg/L.
Mean measured concentrations: 0.0053, 0.017, 0.052, 0.15 and 0.48 mg/L. - Details on test conditions:
- TEST SYSTEM
- Emybro cups: glass scintillation vials
- Test vessel: constructed glass aquaria
- Type of flow-through: peristaltic pumpe
- No. of fertilized eggs/embryos per vessel: 30
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:laboratory treated mains supply.The water was pumped to the laboratory through an activated carbon filter.
- Particulate matter: no (activated carbon filtered)
- Pesticides: analyzed but no significant findings
- Chlorine: 17 mg/L
- Ca/ Mg ratio: 6.7
- Alkalinity: 27.6 mg/L (as CaCO3)
OTHER TEST CONDITIONS
- Adjustment of pH: 7.6
- Photoperiod: 16 hour light:8-hour dark
- Light intensity: 588 to 838 Lux
RANGE-FINDING STUDY
- Test concentrations: 0-0.005-0.05-0.50-5.0 mg/L
- Results used to determine the conditions for the definitive study: yes
POST-HATCH DETAILS
- Start post-hatch phase: 13 days following egg addition
- No. of hatched eggs (alevins)/treatment released to the test chamber: 30
- Reference substance (positive control):
- no
- Duration:
- 30 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.5 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- number hatched
- Key result
- Duration:
- 30 d
- Dose descriptor:
- EC10
- Effect conc.:
- > 0.5 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- number hatched
- Key result
- Duration:
- 30 d
- Dose descriptor:
- EC10
- Effect conc.:
- 0.014 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- weight
- Remarks:
- and weight (most sensitive endpoint)
- Duration:
- 30 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.016 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- adult mortality
- Details on results:
- - Effect concentrations exceeding solubility of substance in test medium: no
- Incidents in the course of the test which might have influenced the results: no - Reported statistics and error estimates:
- Statistical analysis was performed using the CETIS program v 1.8.6.8.
- Validity criteria fulfilled:
- yes
- Conclusions:
- Based on the most sensitive endpoint (length and weight), the EC10 of the effect of the test item to the early life stage of fish (Oryzias latipes) was determined to be 0.014 mg/L over 30-day post hatch phase.
- Executive summary:
The long-term toxicity testing on fish with the substance was evaluated according to OECD TG 210 “Fish, Early Life Stage Toxicity Test (adopted July 2013)”. Due to animal wellfare reasons, this fish test was part of an OECD 234 "Fish Sexual Development Test" (see IUCLID Section 6.1.8). The OECD 234 was desinged such that the endpoints required by the OECD 210 could be evaluated. The tests were performed under GLP with the Japanse medaka (Oryzias latipes) using a flow-through system. Based on the results from a range-finding test, the definitive test was conducted at nominal test concentrations of 0.0050, 0.016, 0.050, 0.16 and 0.50 mg/L. A control group was also included. Four replicate vessels were used for the control and each test concentration. The concentrations were verified via a liquid chromatography-triple quadrupole mass spectrometry (LC-MS/MS) system. The measured concentrations were remained within the 80% to 120% of nominal concentrations during the test. Based on the most sensitive endpoint (length and weight), the EC10 of the effect of the test item to the early life stage of fish was determined to be 0.014 mg/L over 30-day post hatch phase.
Reference
Hatching Success:
Nominal concentration (mg/L) | Hatching success (%) | |
Mean | SD | |
Control | 97 | 2.9 |
0.0050 | 96 | 3.4 |
0.016 | 99 | 1.7 |
0.050 | 94 | 5.1 |
0.16 | 99 | 1.7 |
0.50 | 99 | 1.5 |
30-day Post-hatch survial:
Nominal concentration (mg/L) | Post-hatch survival Day 30 (%) | |
Mean | SD | |
Control | 97 | 2.9 |
0.0050 | 92 | 1.5 |
0.016 | 96 | 3.4 |
0.050 | 51 | 10.0 |
0.16 | 0 | 0 |
0.50 | 0 | 0 |
30-Day Post-hatch Total Length and Wet Weight:
Nominal Concentration (mg/L) | Total length (mm) | Wet weight (mg) | ||
Mean | SD | Mean | SD | |
Control | 15.1 | 2.1 | 38.8 | 13.8 |
0.0050 | 15.7 | 2.3 | 44.6 | 14.3 |
0.016 | 14.8 | 2.1 | 36.4 | 13.2 |
0.050 | 12.9 | 2.0 | 24.2 | 11.9 |
Description of key information
The long-term toxicity testing on fish with the substance was evaluated according to OECD TG 210 “Fish, Early Life Stage Toxicity Test (adopted July 2013)”. Due to animal wellfare reasons, this fish test was part of an OECD 234 "Fish Sexual Development Test" (see IUCLID Section 6.1.8). The OECD 234 was desinged such that the endpoints required by the OECD 210 could be evaluated. The tests were performed under GLP with the Japanse medaka (Oryzias latipes) using a flow-through system. Based on the results from a range-finding test, the definitive test was conducted at nominal test concentrations of 0.0050, 0.016, 0.050, 0.16 and 0.50 mg/L. A control group was also included. Four replicate vessels were used for the control and each test concentration. The concentrations were verified via a liquid chromatography-triple quadrupole mass spectrometry (LC-MS/MS) system. The measured concentrations were remained within the 80% to 120% of nominal concentrations during the test. Based on the most sensitive endpoint (length and weight), the EC10 of the effect of the test item to the early life stage of fish was determined to be 0.014 mg/L over 30-day post hatch phase.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Dose descriptor:
- EC10
- Effect concentration:
- 0.014 mg/L
Additional information
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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