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EC number: 206-735-5 | CAS number: 371-40-4
- 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 aquatic invertebrates
Administrative data
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 2010-12-08 to 2011-09-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to generally valid and/or internationally accepted testing guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-fluoroaniline
- EC Number:
- 206-735-5
- EC Name:
- 4-fluoroaniline
- Cas Number:
- 371-40-4
- Molecular formula:
- C6H6FN
- IUPAC Name:
- 4-fluoroaniline
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- Sampling method:
- Determination of the test item concentration after 0, 24 and 48 h
- Sampling: Duplicate samples from the freshly prepared test media of all test concentrations and the control were taken at the start of the test and at day 1.
- Analyses: For the determination of the stability of the test item under the test conditions and of the maintenance of the test item concentrations during the test period, duplicate samples from the aged test media of all test concentrations and the control were collected at the end of the test and at day 1 (after 24 hours of exposure) by pouring together the contents of the test beakers of each treatment.
The concentrations of the test item were analysed in the duplicate test media samples from all sampling times. From the control samples only one of the duplicate samples was analysed from each sampling times.
- Samples were diluted with acetonitrile
- Sampling storage: All samples were stored in a freezer (≤ - 10 °C), protected from light until analysis was performed.
- Determination of the water quality parameters in the fresh media (0 h) and in the old media (48 h)
- Concentrations (fortified samples): Approximately 10 and 50 mg test item were diluted with 10 and 50 mL pure water to obtain a stock solution of 1 g test item/L. Appropriate amounts of the stock solution were diluted with test water to obtain fortified samples at concentrations of 15, 30, 75 and 450 µg test item/L.
Test solutions
- Vehicle:
- yes
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTIONS
Dosage of test item: A stock solution of 20 mg/L was prepared by dissolving 15 .6 and 13.1 mg test item into 780 and 655 mL test water, respectively, by intense stirring for 5 minutes. Adequate volumes of these stock solutions were diluted with test water to prepare the test media of the desired test concentrations.The test media were prepared just before introduction of Daphnia (= start of the test) and at test medium renewal on Day 1.
Standard solutions used for the Quantification:
Stock solution: The test item was used to prepare the stock solutions. 50.54 and 10.68 mg of the test item were diluted with 50 and 10 mL pure water to obtain stock solutions of approx. 1 g test item/L.
Standard solutions: Appropriate amounts of the stock solutions were diluted with a mixture of 50% acetonitrile / 50% test water (v/v) to obtain standard solutions in the range from 5 to 500 µg test item/L.
- Control: Reconstituted water according to guideline. In the control, test water was used without addition of the test item.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna
- Strain: Straus, clone 5
- Source: laboratories of IBACON
- Age at study initiation: 3.75 to 19.5 hours old.
- Feeding during the test:
Food type: green algae (Desmodesmus subspicatus) freshly grown in the laboratories of IBACON
Frequency: The Daphnia in the stock culture were fed at least on all working days
ACCLIMATION
Acclimatation was not necessary, since the test was performed in the same medium as the culturing.
Study design
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
Test conditions
- Hardness:
- 2.5 mmol/L (~ 250 mg/L) as CaCO3
- Test temperature:
- 20 °C in the freshly prepared media and 20 °C in the aged test media
- pH:
- 7.9 to 8.0 in the freshly prepared media; 7.9 in the aged test media; and thus the pH-value did not vary by more than 1.5 units
- Dissolved oxygen:
- 8.5 to 9.1 mg/L in the freshly prepared media; 8.2 to 9 .0 mg/L in the aged test media
- Salinity:
- 0.9 mmol/L
- Nominal and measured concentrations:
- Nominal concentrations: 0.45, 0.20, 0.093, 0.042 and 0.019 mg test item/L (nominal) and a control.
Measured concentrations: At the start of the test and at test medium renewal 96 % of the nominal test concentration was found (average of all test concentrations). After 24 and 48 hours test duration, 93 % of the nominal value was determined (average of all test concentrations). During the test the Daphnia were exposed to a mean of 95 % of nominal. Therefore, all reported results refer to nominal concentrations. - Details on test conditions:
- TEST SYSTEM:
- Test vessel: Glass beakers of 100 mL volume containing approximately 60 mL of test medium.
- Type and size: The test vessels were covered with a lid to reduce the loss of water due to evaporation and to avoid the entry of dust into the solutions.
- Renewal rate or test solutions: A semi-static test procedure with a test medium renewal at Day 1 was perforrned to keep the test item concentrations in the test media as constant as possible.
- No. of organisms per vessel: 20 Daphnia per control and test concentration,
- No. of vessel per concentration (replicates): 4 groups of 5 animals, each group in 60 mL test medium
- No. vessels per control (replicates): 1
TEST MEDIUM/WATER PARAMETERS
- Test water: Reconstituted Water (Elendt "M4") according to guideline
- Water Hardness: 2.5 mmol/L (= 250 mg/L) as CaCO3
- Alkalinity: 0.9 mmol/L
- Culture medium different from test medium: No
- Intervals of water quality measurements: 24 h
OTHER TEST CONDITIONS:
- Adjustment of pH: No
- Photoperiod: 16 h light-8 h dark
- Light intensity: 650 - 830 lux
EFECT PARAMETERS MEASURED: The mobility of the Daphnia was determined by visual observation after 24 and 48 hours. Those animals not able to swim within 15 seconds after gentle agitation of the test beaker were considered to be immobile (even if they could still move their antennae).
TEST CONCENTRATIONS:
- Test concentrations:
Nominal concentrations: 0.45, 0.20, 0.093, 0.042 and 0.019 mg test item/L (nominal) and a control.
Measured concentrations: At the start of the test and at test medium renewal 96 % of the nominal test concentration was found (average of all test concentrations). After 24 and 48 hours test duration, 93 % of the nominal value was determined (average of all test concentrations). During the test the Daphnia were exposed to a mean of 95 % of nominal. Therefore, all reported results refer to nominal concentrations. - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 24 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.2 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: n.d.
- Duration:
- 24 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 0.45 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: n.d.
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.042 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: n.d.
- Duration:
- 48 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 0.093 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: n.d.
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 0.254 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: n.d.
- Details on results:
- After 48 hours of exposure no immobilisation of the test animals was observed in the control and the test item concentration up to and including nominal 0.042 mg/L.
At the nominal test concentration of 0.093 mg test item/L one Daphnia was immobile. Two immobile Daphnia were observed at the nominal test concentration of 0.20 mg test item/L. At the highest nominal test concentration of 0.45 mg test item/L, 20 animals were immobile.
The NOEC was determined to be 0.042 mg test item/L, the LOEC was determined to be 0.093 mg test item/L and the EC50 value was calculated to be 0.254 mg test item/L. All reported results refer to nominal concentration.
All validity criteria were met. - Results with reference substance (positive control):
- The EC50 after 24 hours was determined to be 1.63 mg test item/L indicating that the sensitivity of the Daphnia was consistent with the level proposed by the OECD 202 guideline (EC50-24 h between 0.6 and 2.1 mg potassium dichromate/L).
- Reported statistics and error estimates:
- The 24-hour and 48-hour EC50 and the 95 % confidence limits were calculated by Probit analysis.
- The NOEC and LOEC after 24 and 48 hours were determined directly from the raw data.
- The software used to perform the statistical analysis was ToxRat. Professional, Version 2.10.05, ToxRat® Solutions GmbH.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- In the semi-static immobilization test, young Daphnia magna STRAUSS (< 24 h old) were exposed to the test item for 48 hours according to OECD guideline No. 202 (2004). The NOEC was determined to be 0.042 mg test item/L, the LOEC was determined to be 0.093 mg test item/L and the EC50 value was calculated to be 0.254 mg test item/L. All reported results refer to the nominal concentrations.
- Executive summary:
ln the acute immobilization test with Daphnia magna (STRAUS), the effects of the test substance with a nominal loading of 0.45, 0.20, 0.093, 0.042 and 0.019 mg test item/L and a control were determined according to OECD-Guideline for Testing of Chemicals No.202 (2004) and Council Regulation (EC) No. 440/2008 Method C.2 (2008). The study encompassed 6 treatment groups (5 dose rates of the test item, control) each containing 20 individuals. The mobility of the Daphnia was determined in a semi static 48-hour test by visual observation after 24 and 48 hours. The samples collected at start and after each sampling time were analyzed via HPLC-method. In the test with the reference item potassium dichromate performed in January 2011, the EC50 after 24 hours was determined to be 1.63 mg test item/L indicating that the sensitivity of the Daphnia was consistent with the level proposed by the OECD 202 guideline (EC50-24 h between 0.6 and 2.1 mg potassium dichromate/L), therefore all validity criteria were met. At the start of the test and at test medium renewal 96 % of the nominal test concentration was found (average of all test concentrations). After 24 and 48 hours test duration, 93 % of the nominal value was determined (average of all test concentrations). During the test the Daphnia were exposed to a mean of 95 % of nominal. Therefore, all reported results refer to nominal concentrations. The 48-hour NOEC was determined to be 0.042 mg test item/L, the 48-hour LOEC was determined to be 0.093 mg test item/L and the 48-hour EC50 value was calculated to be 0.254 mg test item/L.
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