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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 902-591-9 | 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
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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- other: EPA-660/3-75-009, 1975
- Principles of method if other than guideline:
- Test procedures followed the basic flow-through test method described by the U. S. Environmental Protection Agency (EPA-660/3-75-009, 1975)
- GLP compliance:
- not specified
- Analytical monitoring:
- yes
- Vehicle:
- no
- Details on test solutions:
- Water for all tests was untreated and obtained directly from Lake Superior and heated to mean test temperature.
- Test organisms (species):
- Lepomis macrochirus
- Details on test organisms:
- TEST ORGANISM
- Common name: bluegill
- Source: Lake Mills Fish Hatchery, Lake Mills, WI, USA
- Weight at study initiation (mean and range, SD): Average weights of exposed fish were obtained by weighing control fish from each test. Average weight of bluegills was 3.07 ± 1.38 g
- Feeding during test: Fish were not fed 24 h before or during a test
- holding before 24 h before test: at respective test temperature and fed a commercial formulation of dry food. - Test type:
- flow-through
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Hardness:
- 46.6 mg/L CaCO3 (40.4 - 56.3)
- Test temperature:
- 19.8 ± 2.3 °C
- pH:
- 7.04 - 7.97
- Dissolved oxygen:
- 78.8 % (54.3 - 88.9)
- Nominal and measured concentrations:
- five test concentrations and a control
- Details on test conditions:
- TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: 530-L fiberglass holding tanks
- Type of flow-through (e.g. peristaltic or proportional diluter): The exposure system for fish consisted of several modified proportional diluters with dilution factors ranging from 0.6 to 0.8. Each diluter cycle delivered 1.0 L of water and toxicant, where appropriate, to each of five test concentrations and a control. Each test concentration and control was duplicated by dividing the original volume equally using flow-splitting tanks. The glass exposure tanks contained 6.3 L water. Diluters were cycled at a rate to yield 5 to 8 tank volumes/day.
- No. of organisms per vessel: 10
TEST MEDIUM / WATER PARAMETERS
- Alkalinity: 41.7 mg/L CaCO3 (30.0 - 46.0)
- Mean dissolved oxygen: 78.8 % (54.3 - 88.9) - Reference substance (positive control):
- no
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 15 400 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 95% CL: 13500-17600
- Duration:
- 96 h
- Dose descriptor:
- EC50
- Effect conc.:
- 12 700 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 95% CL: 11800-13700
- Details on results:
- not specified
- Results with reference substance (positive control):
- not applicable
- Reported statistics and error estimates:
- not specified
- Validity criteria fulfilled:
- not specified
- Conclusions:
- The 96-hour LC50 and EC50 were found to be 15400 mg/L and 12700 mg/L (measured), respectively.
- Executive summary:
In a 96-hour flow-through test with following the principles described by the U.S. Environmental Protection Agency (EPA-660/3-75-009, 1975) fish (Lepomis macrochirus, 10 animals per vessel) were exposed to five concentrations (not further specified) of the test item and a control. Dead fish were counted and removed at 1, 3, 6, 12 and 24 h after initial exposure and at 24-h periods thereafter. Mortality data from duplicate exposure tanks were combined before LC50 and EC50 determinations were made. As a result, the 96-hour LC50 and EC50 were found to be 15400 mg/L and 12700 mg/L (measured), respectively.
- 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:
- test procedure in accordance with national standard methods with acceptable restrictions
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- other: EPA-660/3-75-009, 1975
- Principles of method if other than guideline:
- Test procedures followed the basic flow-through test method described by the U. S. Environmental Protection Agency (EPA-660/3-75-009, 1975)
- GLP compliance:
- not specified
- Analytical monitoring:
- yes
- Vehicle:
- no
- Details on test solutions:
- Water for all tests was untreated and obtained directly from Lake Superior and heated to mean test temperature.
- Test organisms (species):
- Oncorhynchus mykiss (previous name: Salmo gairdneri)
- Details on test organisms:
- TEST ORGANISM
- Common name: rainbow trout
- Source: Fattig Hatcheries, Brady, NE, USA
- Weight at study initiation (mean and range, SD): Average weights of exposed fish were obtained by weighing control fish from each test. Average weight of rainbow trouts was 0.813 ± 0.136 g
- Feeding during test: Fish were not fed 24 h before or during a test
- holding before 24 h before test: at respective test temperature and fed a commercial formulation of dry food. - Test type:
- flow-through
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Hardness:
- 46.6 mg/L CaCO3 (40.4 - 56.3)
- Test temperature:
- 12.7 ± 1.0 °C
- pH:
- 7.04 - 7.97
- Dissolved oxygen:
- 78.8 % (54.3 - 88.9)
- Nominal and measured concentrations:
- five test concentrations and a control
- Details on test conditions:
- TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: 530-L fiberglass holding tanks
- Type of flow-through (e.g. peristaltic or proportional diluter): The exposure system for fish consisted of several modified proportional diluters with dilution factors ranging from 0.6 to 0.8. Each diluter cycle delivered 1.0 L of water and toxicant, where appropriate, to each of five test concentrations and a control. Each test concentration and control was duplicated by dividing the original volume equally using flow-splitting tanks. The glass exposure tanks contained 6.3 L water. Diluters were cycled at a rate to yield 5 to 8 tank volumes/day.
- No. of organisms per vessel: 10
TEST MEDIUM / WATER PARAMETERS
- Alkalinity: 41.7 mg/L CaCO3 (30.0 - 46.0)
- Mean dissolved oxygen: 78.8 % (54.3 - 88.9) - Reference substance (positive control):
- no
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 20 100 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 95% CL: 19500-27000
- Duration:
- 96 h
- Dose descriptor:
- EC50
- Effect conc.:
- 13 000 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 95% CL: 12800-13400
- Validity criteria fulfilled:
- not specified
- Conclusions:
- The LC50 (96 h) was determined to be 20100 mg/L (measured).
- Executive summary:
In a 96-hour flow-through test with following the principles described by the U.S. Environmental Protection Agency (EPA-660/3-75-009, 1975) fish (Oncorhynchus mykiss, 10 animals per vessel) were exposed to five concentrations (not further specified) of the test item and a control. Dead fish were counted and removed at 1, 3, 6, 12 and 24 h after initial exposure and at 24-h periods thereafter. Mortality data from duplicate exposure tanks were combined before LC50 and EC50 determinations were made. As a result, the 96-hour LC50 and EC50 were found to be 20100 mg/L and 13000 mg/L (measured), respectively.
- 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:
- test procedure in accordance with national standard methods with acceptable restrictions
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- other: EPA-660/3-75-009, 1975
- Principles of method if other than guideline:
- Test procedures followed the basic flow-through test method described by the U. S. Environmental Protection Agency (EPA-660/3-75-009, 1975)
- GLP compliance:
- not specified
- Analytical monitoring:
- yes
- Vehicle:
- no
- Details on test solutions:
- Water for all tests was untreated and obtained directly from Lake Superior and heated to mean test temperature.
- Test organisms (species):
- Pimephales promelas
- Details on test organisms:
- TEST ORGANISM
- Common name: fathead minnow
- Source: US EPA Environmental Research Laboratory-Duluth, Duluth, MN, USA
- Weight at study initiation (mean and range, SD): Average weights of exposed fish were obtained by weighing control fish from each test. Average weight was 0.126 ± 0.36 g
- Age at study initiation: 28 - 32 days
- Feeding during test: Fish were not fed 24 h before or during a test
- holding before 24 h before test: larvae and fry fed with live San Francisco Bay brine shrimp - Test type:
- flow-through
- Water media type:
- freshwater
- Total exposure duration:
- 96 h
- Hardness:
- 46.6 mg/L CaCO3 (40.4 - 56.3)
- Test temperature:
- 23.3 ± 1.7 °C
- pH:
- 7.04 - 7.97
- Dissolved oxygen:
- 85.2 % (78.1 - 98.0)
- Nominal and measured concentrations:
- five test concentrations and a control
- Details on test conditions:
- TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: 530-L fiberglass holding tanks
- Type of flow-through (e.g. peristaltic or proportional diluter): The exposure system for fish consisted of several modified proportional diluters with dilution factors ranging from 0.6 to 0.8. Each diluter cycle delivered 1.0 L of water and toxicant, where appropriate, to each of five test concentrations and a control. Each test concentration and control was duplicated by dividing the original volume equally using flow-splitting tanks. The glass exposure tanks contained 6.3 L water. Diluters were cycled at a rate to yield 5 to 8 tank volumes/day.
- No. of organisms per vessel: 10
TEST MEDIUM / WATER PARAMETERS
- Alkalinity: 41.7 mg/L CaCO3 (30.0 - 46.0)
- Mean dissolved oxygen: 78.8 % (54.3 - 88.9) - Reference substance (positive control):
- no
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 29 400 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 95% CL: 13500-17600
- Duration:
- 96 h
- Dose descriptor:
- EC50
- Effect conc.:
- 28 900 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 95% CL: 11800-13700
- Validity criteria fulfilled:
- no
- Conclusions:
- The 96-hour LC50 and EC50 were found to be 29400 mg/L and 28900 mg/L (measured), respectively.
- Executive summary:
In a 96-hour flow-through test with following the principles described by the U.S. Environmental Protection Agency (EPA-660/3-75-009, 1975) fish (Pimephales promelas, 10 animals per vessel) were exposed to five concentrations (not further specified) of the test item and a control. Dead fish were counted and removed at 1, 3, 6, 12 and 24 h after initial exposure and at 24-h periods thereafter. Mortality data from duplicate exposure tanks were combined before LC50 and EC50 determinations were made. As a result, the 96-hour LC50 and EC50 were found to be 29400 mg/L and 28900 mg/L (measured), respectively.
- Endpoint:
- fish embryo acute toxicity (FET)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: OECE 212: Fish, Short-term Toxicity Test on Embryo and Sac-Fry Stages
- GLP compliance:
- not specified
- Remarks:
- GLP-compliance not reported in the literature.
- Analytical monitoring:
- not specified
- Vehicle:
- not specified
- Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- - Organism: embryo Danio rerio; only eggs in blastula stage (3-4 h after fertilization) were chosen for testing
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Test temperature:
- 26.8°C
- Dissolved oxygen:
- > 60% dissolved oxygen
- Nominal and measured concentrations:
- - Concentrations tested: 0.1, 0.5, 1, 1.5, 2 % plus control
- Details on test conditions:
- TEST SYSTEM
- Test substance renewal: after 24 h
- Test vessel: Petri dishes (20 ml)
- No. of replicates per concentration: 12
- No. of animals per replicate: 10
- No. of animals per concentration: 120
- Testing was terminated after all individuals in control were hatched, having absorbed the yolk sac
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- The development of embryos from blastula to early larval stages, hatching rate, and mortality were monitored at 24, 48, 72 and 96 h. - Key result
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 3.95 g/L
- Conc. based on:
- test mat.
- Basis for effect:
- morphology
- Details on results:
- NOEC concentration of methanol: 0.5 % v/v
--> 5 ml : 1000 ml
5 ml * 0.79 g/ml = 3.95 g/L - Validity criteria fulfilled:
- not specified
- Conclusions:
- The 96 h NOEC (morphology) of the test item was determined to be 0.5 % v/v which corresponds to 3.95 g/L.
- Executive summary:
In a semi-static Fish, Short-term Toxicity Test on Embryo and Sac-Fry Stages Test according to OECE Guideline 212 the short-term toxicity of Methanol to Danio rerio was assessed at concentration levels of 0.1, 0.5, 1, 1.5, 2 % along with a negative control. Ten embryos per concentration with ten replicates were exposed over 96 hours with a substance renewal every 24 hours. The testing was terminated after all individuals in control were hatched, having absorbed the yolk sac. The 96 h NOEC (morphology) of the test item was determined to be 0.5 % v/v which corresponds to 3.95 g/L.
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Remarks:
- The study was conducted in order to compare acute toxicity of methanol in adult zebrafish to fish eggs. Only insufficient information on methodology, test concentrations and test performance was given and thus, the reliability of the study could not be assessed.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)
- Principles of method if other than guideline:
- The purpose of the study was the comparison of acute toxicity data in adult zebrafish to fish eggs according to OECD guidelines 203 and 210, respectively.
- GLP compliance:
- not specified
- Analytical monitoring:
- not specified
- Vehicle:
- not specified
- Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- Organisms used for study: adult Danio rerio and fish eggs
- Test type:
- not specified
- Water media type:
- freshwater
- Total exposure duration:
- 96 h
- Reference substance (positive control):
- not required
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 22 300 mg/L
- Remarks on result:
- other: adult fish
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 290 mg/L
- Remarks on result:
- other: fish embryos
- Details on results:
- not specified
- Results with reference substance (positive control):
- not applicable
- Reported statistics and error estimates:
- not specified
- Validity criteria fulfilled:
- not specified
- Conclusions:
- The 96-hour LC50 (adult fish) was 22300 mg/L and the 96-hour LC50 (fish embryo) was 290 mg/L.
- Executive summary:
To compare the acute toxicity data in adult zebrafish to fish eggs (Danio rerio) a test according to theOECD guidelines 203 and 210, respectively, was performed. In result, the 96-hour LC50 (adult fish) was 22300 mg/L and the 96-hour LC50 (fish embryo) was 290 mg/L.
- Endpoint:
- short-term toxicity to fish
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- Please refer to IUCLID section 13 for Read Across Justification.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- >= 250 - <= 350 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality (fish)
- Endpoint:
- short-term toxicity to fish
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- Please refer to IUCLID section 13 for Read Across Justification.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 3.95 g/L
- Nominal / measured:
- not specified
- Conc. based on:
- test mat.
- Basis for effect:
- morphology
- Endpoint:
- short-term toxicity to fish
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- Please refer to IUCLID section 13 for Read Across Justification.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 15 400 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 95% CL: 13500-17600
- Duration:
- 96 h
- Dose descriptor:
- EC50
- Effect conc.:
- 12 700 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 95% CL: 11800-13700
- Endpoint:
- short-term toxicity to fish
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- Please refer to IUCLID section 13 for Read Across Justification.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 29 400 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 95% CL: 13500-17600 mg/L
- Duration:
- 96 h
- Dose descriptor:
- EC50
- Effect conc.:
- 28 900 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 95% CL: 11800-13700 mg/L
- Endpoint:
- short-term toxicity to fish
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- Please refer to IUCLID section 13 for Read Across Justification.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 20 100 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 95% CL: 19500-27000 mg/L
- Duration:
- 96 h
- Dose descriptor:
- EC50
- Effect conc.:
- 13 000 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 95% CL: 12800-13400 mg/L
- Endpoint:
- short-term toxicity to fish
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- Please refer to IUCLID section 13 for Read Across Justification.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 22 300 mg/L
- Nominal / measured:
- not specified
- Conc. based on:
- not specified
- Basis for effect:
- not specified
- Remarks on result:
- other: adult fish
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 290 mg/L
- Nominal / measured:
- not specified
- Conc. based on:
- not specified
- Basis for effect:
- not specified
- Remarks on result:
- other: fish embryos
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 29.02.1988 - 06.05.1988
- 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:
- 1984
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Version / remarks:
- 1984
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- Data owner has QAU statement
- Analytical monitoring:
- no
- Vehicle:
- no
- Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: zebrafish
- Strain: Hamilton-Buchanan
- Source: own breeding (Kastengrund)
- Age at study initiation: dates of hatch: 03.10./15.10./24.11.87, and 17.01.88
- Length at study initiation: 2.4 - 3.2 cm, mean 2.8 cm, SD 0.20 cm
- Feeding during test: animals were not fed during the test
ACCLIMATION
- Acclimation period: 14 days
- Acclimation condition: same as test
- Type and amount of food: Tetra Min ad libitum
- Feeding frequency: twice per day
- Health during acclimation: no mortalities reported - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Post exposure observation period:
- not specified
- Hardness:
- not specified
- Test temperature:
- 21.2°C - 22.9°C
- pH:
- 7.3 - 8.2
- Dissolved oxygen:
- 6.1 - 9.3 mg/l
- Salinity:
- not applicable
- Conductivity:
- not specified
- Nominal and measured concentrations:
- Nominal: 0, 100, 250, 350, 500, 1000, 1800 and 5000 mg a.i./L
- Details on test conditions:
- TEST SYSTEM
- Test vessel:
- Type: open
- Material, size, headspace, fill volume: glass vessel (30 cm*22cm*24 cm), fill volume 10 litre
- Aeration: no
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 7 (one per each test )
- Biomass loading rate: <= 1 g fish / litre
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water according to ISO/DIS 7346/1
- Culture medium different from test medium: no
OTHER TEST CONDITIONS
- Photoperiod: 12 hours light/12 hours dark
- Light intensity: 700 lux
EFFECT PARAMETERS MEASURED: mortality and changes in behaviour were monitored daily
TEST CONCENTRATIONS
- Spacing factor for test concentrations: squareroot of 2
- Concentrations used inthe test: 0 / 100 / 250 / 350 / 500 / 1000 / 1800 / 5000 mg/L - Reference substance (positive control):
- no
- Duration:
- 48 h
- Dose descriptor:
- LC0
- Effect conc.:
- 250 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality (fish)
- Duration:
- 48 h
- Dose descriptor:
- LC50
- Effect conc.:
- >= 250 - <= 350 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality (fish)
- Duration:
- 48 h
- Dose descriptor:
- LC100
- Effect conc.:
- 500 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LC0
- Effect conc.:
- 250 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality (fish)
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- >= 250 - <= 350 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LC100
- Effect conc.:
- 500 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality (fish)
- Details on results:
- - Behavioural abnormalities: reduced breathing, swimming at the surface, lying at the bottom of the test vessel, passive sliding to the bottom, reduced as well as increased activity, loss of equilibrium, convulsions
- Other biological observations: dead fish were pale with reddened gills
- Mortality of control: no
- Other adverse effects control: none - Results with reference substance (positive control):
- not applicable
- Reported statistics and error estimates:
- not specified
- Sublethal observations / clinical signs:
Table: Toxicity of methyl acetate to fish (mortality data)
Treatment [mg a.i./L]
(nominal concentration)No. of fish at start of study Observation period 48 hours 96 hours No dead fish % mortality No dead fish % mortality Control 70* 0 0 0 0 100 10 0 0 0 0 250 10 0 0 0 0 350 10 9 90 9 90 500 10 10 100 10 100 1000 10 10 100 10 100 1800 10 10 100 10 100 5000 10 10 100 10 100 *10 for each test concentration
Abnormal effects and mortality were observed at test at all concentrations of 350 mg/l and higher. Abnormal effects but no mortality were observed at 250 mg/L. No effects were observed at 100 mg/l.
- Validity criteria fulfilled:
- yes
- Conclusions:
- Based on the results of the test, the 96 hour LC50 for the test item was determined to be between 250 and 350 mg a.i./L
- Executive summary:
In a 96-h acute toxicity study according to OECD 203, zebra fish (Brachidanio rerio) were exposed to methyl acetate at nominal concentrations of 0, 100, 250, 350, 500, 1000, 1800 and 5000 mg a.i./L under static conditions. The 96-h LC50 was 250 - 350 mg a.i./L. The LC0 and LC100 values, based on mortality, were 250 and 500 mg a.i./L, respectively. Sublethal effects of protruding gills, increased and decreased breathing, passive sinking, swimming at the surface, increased and decreased activity, edema, tremours, convulsions were observed in the groups exposed to 350, 500, 1000, 1800, and 5000 mg a.i./L.
Referenceopen allclose all
Description of key information
The 96-hour LC50 of the registration substance is considered to be 250 mg/L.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 250 mg/L
Additional information
No data on short-term toxicity to fish are available for the registration substance itself, but for the read across source substances Methanol and Methyl acetate.
Methanol
In a 96-hour flow-through test following the principles described by the U.S. Environmental Protection Agency (EPA-660/3-75-009, 1975) fish species (10 animals per vessel) were exposed to five concentrations (not further specified) of the test item and a control. Dead fish were counted and removed at 1, 3, 6, 12 and 24 h after initial exposure and at 24-h periods thereafter. Mortality data from duplicate exposure tanks were combined before LC50 and EC50 determinations were made. As a result, the 96-hour LC50 and EC50 for Oncorhynchus mykiss were found to be 20100 mg/L and 13000 mg/L (measured), respectively. With the same test setup and test design using Pimephales promelas the 96-hour LC50 and EC50 were determined to be 29400 mg/L and 28900 mg/L (measured), respectively. The 96-hour LC50 and EC50 were found to be 15400 mg/L and 12700 mg/L (measured), respectively (Poirer et al., 1986).
In a semi-static Fish, short-term toxicity test on embryo and sac-fry stages according to OECD Guideline 212 the short-term toxicity of Methanol to Danio rerio was assessed at concentration levels of 0.1, 0.5, 1, 1.5, 2 % along with a negative control. Ten embryos per concentration with ten replicates were exposed over 96 hours with a substance renewal every 24 hours. The testing was terminated after all individuals in control were hatched, having absorbed the yolk sac. The 96 h NOEC (morphology) of the test item was determined to be 0.5 % v/v which corresponds to 3.95 g/L (Chromcova et al., 2012).
To compare the acute toxicity data in adult zebrafish (Danio rerio) to fish eggs a test according to the OECD guidelines 203 and 210, respectively, was performed (Zeljenkova et al., 2006). In result, the 96-hour LC50 (adult fish) was 22300 mg/L and the 96-hour LC50 (fish embryo) was 290 mg/L. Because of insuffient documentation this information was classified "not assignable" (Klimisch 4).
Methyl acetate
In a GLP-compliant 96-h acute toxicity study according to OECD 203, zebra fish (Danio rerio) were exposed to Methyl acetate at nominal concentrations of 0, 100, 250, 350, 500, 1000, 1800 and 5000 mg a.i./L under static conditions (Markert & Jung, 1988). The 96-h LC50 was 250 - 350 mg a.i./L. The LC0 and LC100 values, based on mortality, were 250 and 500 mg a.i./L, respectively. Sublethal effects of protruding gills, increased and decreased breathing, passive sinking, swimming at the surface, increased and decreased activity, edema, tremours, convulsions were observed in the groups exposed to 350, 500, 1000, 1800, and 5000 mg a.i./L. The 96-h LC50 was 250 - 350 mg a.i./L. The lower value is given as key value.
Conclusion
No experimental data are available for the registration substance itself. Therefore, a read across approach to the source substances Methanol and Methyl acetate was applied. In continuous flow-through systems LC50 (96 h) values for Methanol were found to be 29400 mg/L (Pimephales promelas), 20100 mg/L (Salmo gairdneri) and 15400 mg/L (Lepomis macrochirus), respectively (Poirer, 1986). These values are supported by results of studies with Methanol according to OECD guidelines 203 and 210 (Zeljenkova et al., 2006) and a semi-static fish, short-term toxicity test on embryo and sac-fry stages according to OECD Guideline 212 (Chromcova et al., 2012). For the read across substance Methyl acetate the 96-h LC50 was determined to be 250 mg a.i./L (Markert & Jung, 1988). By applying a read across approach and under worst case assumption, the 96-h LC50 for the target substance is considered to be 250 mg/L based on the study by Markert & Jung (1988) with the analogue substance Methyl acetate.
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.