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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
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 9 January 2012 to 3 February 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- ISO 7346-1 (Determination of the Acute Lethal Toxicity of Substances to a Freshwater Fish [Brachydanio rerio Hamilton-Buchanan (Teleostei, Cyprinidae)] - Part 1: Static Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Identification: FAT 40854/A TE
Description: Reddish-brown powder (determined at NOTOX)
Batch: TZ 5719 / BOP 02-11
Content: 46.2 % (4 main constituents)
Test substance storage: At room temperature in the dark
Stability under storage conditions: Stable
Expiry date: 01 April 2016
Stability in water: Stability for at least 6 hours at room temperature
Solubility in water: More than 80 g/L - Analytical monitoring:
- yes
- Details on sampling:
- During the final limit test singular samples for possible analysis were taken from both test groups according to the schedule below.
Frequency: at t=0 h and t=96 h
Volume: 3 mL
Storage: Samples were stored in a freezer until analysis.
Additionally, singular reserve samples of 3 mL were taken from all test solutions for possible analysis. If not already used, these samples were stored in a freezer for a maximum of three months after delivery of the draft report, pending on the decision of the sponsor for additional analysis. - Vehicle:
- no
- Details on test solutions:
- The batch of FAT 40854/A tested was a reddish-brown powder consisting of 4 main constituents (46.2 %) and the substance was completely soluble in test medium at the concentrations tested.
Preparation of test solutions started with the highest concentration of 100 mg/l. No special treatment other than careful mixing was necessary to completely dissolve the test substance in test medium. The lower test concentrations for the range-finding test were prepared by subsequent dilutions of the highest concentration in test medium. The final test solutions ranged from clear and very slightly orange at 0.10 mg/l to clear red at 100 mg/l. - Test organisms (species):
- Cyprinus carpio
- Details on test organisms:
- TEST ORGANISM
- Common name: Carp (Cyprinus carpio, Teleostei, Cyprinidae)
- Source: Zodiac, proefacc, "De Haar Vissen", Wageningen University and Research Centre, The Netherlands
- Length at study initiation (length definition, mean, range and SD): Final limit test: 2.4 ± 0.2 cm
- Weight at study initiation (mean and range, SD): Final limit test: 0.40 ± 0.09 g
- Feeding during test: no feeding
ACCLIMATION
- Acclimation period: At least 12 days after delivery
- Acclimation conditions (same as test or not): same as the test
- Feeding: Daily with pelleted fish food (Trouvit)
- Health during acclimation (any mortality observed): In the batch of fish used for the test, mortality during the seven days prior to the start of the test was less than 5 %. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Hardness:
- 180 mg/L expressed as CaCO3
- Test temperature:
- Between 21.2 and 22.1 °C
- pH:
- Between 7.2 and 7.9
- Dissolved oxygen:
- Between 6.3 and 9.4 mg/L
- Nominal and measured concentrations:
- Analysis of the samples taken from 100 mg/L at the start of the test showed an initial concentration of 114 mg/L. This concentration remained stable during the test period (102 % of initial).
- Details on test conditions:
- TEST SYSTEM
- Test vessel: 10 litres, all glass
- Aeration: Aeration was applied during the last 24 hours of exposure
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.31 g fish/litre
TEST MEDIUM / WATER PARAMETERS
Adjusted ISO medium, formulated using RO-water (tap-water purified by reverse osmosis; GEON Waterbehandeling, Berkel-Enschot, The Netherlands) with the following composition:
CaCl2.2H2O: 211.5 mg/L
MgSO4.7H2O: 88.8 mg/L
NaHCO3: 46.7 mg/L
KCl: 4.2 mg/L
- Intervals of water quality measurement: Dissolved oxygen content pH and temperature, Daily in all vessels with surviving fish, beginning at the start of the test (day 0).
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours photoperiod daily
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : LC50 t=24, 48, 72, 96 h
TEST CONCENTRATIONS
- Final limit study: control and 100 mg/L - Reference substance (positive control):
- yes
- Remarks:
- pentachlorophenol (PCP)
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: Nominal test substance concentrations were analytically confirmed.
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- Behavioral abnormalities:
- Mortality of control: No mortality in control
- Abnormal responses: no abnormalities were observed
- Effect concentrations exceeding solubility of substance in test medium: no - Results with reference substance (positive control):
- The 96h-LC50 was 0.25 mg/L based on nominal concentrations, with a 95 % confidence interval between 0.20 and 0.41 mg/L. This effect was already reached within 24 hours of exposure.
- Sublethal observations / clinical signs:
Range-finding test
No mortality or clinical effects were observed at any of the test concentrations during the test period. Based on these results samples taken from nominal 100 mg/l were analysed. The initial concentration was 112 mg/l. This concentration remained stable during the test period (102-105 % of initial). Therefore, the expected LC50was above 100 mg/l.
Limit test
Measured concentrations
Analysis of the samples taken from 100 mg/l at the start of the test showed an initial concentration of 114 mg/l. This concentration remained stable during the test period (102 % of initial).
Mortality and other effects
No mortality or clinical effects were observed in the two test groups. Hence, results were in agreement with the results of the range-finding test.
- Validity criteria fulfilled:
- yes
- Conclusions:
- The 96h-LC50 and NOEC in carp is >100 and 100 mg/L, respectively.
- Executive summary:
In a GLP-compliant 96 h acute toxicity study in Carp with FAT 40854/A conducted according to OECD guideline 203 and EU method C.1 using static method. The batch of FAT 40854/A tested was a reddish-brown powder consisting of 4 main constituents (46.2 %) and the substance was completely soluble in test medium at the concentrations tested. A final test was performed as a limit based on the results of a preceding range-finding test. Seven carp per test group were exposed to a control and a nominal FAT 40854/A concentration of 100 mg/l in the limit test. The total test period was 96 hours. Samples for analytical confirmation of actual exposure concentrations were taken from both test groups at the start and the end of the test period. Analysis of the samples taken from 100 mg/l at the start of the test showed an initial concentration of 112 mg/l. This concentration remained stable during the test period (102 % of initial). The study met the acceptability criteria prescribed by the protocol and was considered valid. Under the conditions of the present test FAT 40854/A induced no visible or lethal effects in carp at or below 100 mg/l (NOEC). The 96h-LC50 exceeded an analytically confirmed nominal concentration of 100 mg/l.
Reference
Description of key information
The 96h-LC50 of test substance was >100 mg/L.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 100 mg/L
Additional information
In a GLP-compliant 96 h acute toxicity study in Carp with FAT 40854/A conducted according to OECD guideline 203 and EU method C.1 using static method. The batch of FAT 40854/A tested was a reddish-brown powder consisting of 4 main constituents (46.2 %) and the substance was completely soluble in test medium at the concentrations tested. A final test was performed as a limit based on the results of a preceding range-finding test. Seven carp per test group were exposed to a control and a nominal FAT 40854/A concentration of 100 mg/l in the limit test. The total test period was 96 hours. Samples for analytical confirmation of actual exposure concentrations were taken from both test groups at the start and the end of the test period. Analysis of the samples taken from 100 mg/l at the start of the test showed an initial concentration of 112 mg/l. This concentration remained stable during the test period (102 % of initial). The study met the acceptability criteria prescribed by the protocol and was considered valid. Under the conditions of the present test FAT 40854/A induced no visible or lethal effects in carp at or below 100 mg/l (NOEC). The 96h-LC50 exceeded an analytically confirmed nominal concentration of 100 mg/l.
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