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EC number: 244-479-6 | CAS number: 21615-47-4
- 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 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:
- 29 Feb - 04 Mar 2016
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Non-GLP study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- 1992
- GLP compliance:
- no
- Remarks:
- This study was not initially performed for REACh purposes but for other regulatory programs where the studies are not needed to be in compliance with GLP.
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: Samples from all test solutions were analysed at test start and test end.
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Required amount of the test sample and dilution water were mixed and stirred in test vessel to prepare the test solution.
- Eluate: no
- Differential loading: yes
- Controls: yes, test medium control - Test organisms (species):
- Oryzias latipes
- Details on test organisms:
- TEST ORGANISM
- Common name: medaka
- Source: CERI Kurume (in-laboratory production)
- Length at study initiation (length definition, mean, range and SD): 2.0 ± 1.0 cm
- Age at study initiation: four months
ACCLIMATION
- Acclimation conditions (same as test or not): flow-through conditions at 24 ± 1 °C and 80% air saturation
- Type and amount of food during acclimation: Feed of Medaka for education (KYORlN); Amount corresponding to 3% of body weight was fed every day.
- Health during acclimation (any mortality observed): healthy status
FEEDING DURING TEST
- None - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Hardness:
- 37 mg/L as CaCO3
- Test temperature:
- 23.5 - 24.3 °C
- pH:
- 7.4 - 7.8
- Dissolved oxygen:
- 7.4 - 8.2 mg/L
- Nominal and measured concentrations:
- nominal: control, 911, 1280, 1790, 2500, 3500 mg/L
measured: n.d., 976, 1380, 1870, 2580, 3640 mg/L (geom. mean) - Details on test conditions:
- TEST SYSTEM
- Test vessel: 3 L glass tank (diameter: 16 cm, depth: 16 cm), covered with a transparent plastic lid maintained in a water bath
- Aeration: gently aerated
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: dechlorinated tap water
- Total organic carbon: < 0.5 mg/L
- Particulate matter: < 1 mg/L
- Pesticides: not detected
- Chlorine: < 0.02 mg/L
- Alkalinity: 38 mg/L
- Culture medium different from test medium: no
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: Room light, 16-hour light/8-hour dark
EFFECT PARAMETERS MEASURED
- Mortality and visible abnormality were observed at 3, 24, 48, 72 and 96 h after the start of exposure.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.4
- Range finding study
- Test concentrations: 100, 316, 1000, 3160, 10000 mg/L
- Results used to determine the conditions for the definitive study: above 1000 mg/L all fish were dead - Reference substance (positive control):
- no
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 1 850 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- - Mortality of control: 0%
- Abnormal responses: No abnormal response was obtained in the control. At the end of the study one fish was swimming at the surface and partial loss of equilibrium at 1280 mg/L.
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: The test solutions in all exposure levels were colorless and clear at the start of exposure, and a little bubbles were observed. The test solutions in exposure levels of 2500 and 3500 mg/L were colorless and clear at the time that all test organisms were confirmed to be dead, and a little bubbles were also observed. The test solutions in other exposure levels were slightly white suspended at the end of exposure. The test solution in the control was colorless and clear at the start and end of exposure.
- Effect concentrations exceeding solubility of substance in test medium: no - Reported statistics and error estimates:
- Binominal test to determine the LC50.
- Sublethal observations / clinical signs:
Table 1: Cumulative mortality during exposure.
Nominal concentration [mg/L]
Cumulative mortality [%]
3 h
24 h
48 h
72 h
96 h
Control
0
0
0
0
0
911
0
0
0
0
0
1280
0
0
0
0
0
1790
0
0
14
29
43
2500
14
100
100
100
100
3500
14
100
100
100
100
The measured concentrations of the test item in the test solutions were 945-3610 mg/L (102-106% of the nominal concentrations) at the start of exposure and 1010-3680 mg/L (104-111% of the nominal concentrations) at the end of exposure (including the time that all test organisms were confirmed to be dead), and kept within ± 20% of the nominal concentrations.
- Validity criteria fulfilled:
- yes
- Endpoint:
- fish embryo acute toxicity (FET)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 12 - 17 Apr 2018
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 236 (Fish embryo acute toxicity (FET) test)
- GLP compliance:
- no
- Analytical monitoring:
- no
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test item was weighed and directly dissolved in dilution water.
- Eluate: no
- Controls: yes, test medium control - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: zebra fish
- Source: National Institute for Environmental Studies, Japan and Tsunashima Fishing Co.
- Collection of fertilized eggs: Freshly fertilized eggs were obtained from natural mating. Eggs were collected in 0.003% sodium hypochlorite solution as fungicide and rinsed three times with rearing water. Viable eggs were selected by microscopic observation. - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 120 h
- Test temperature:
- 28 ± 0.5 °C
- Nominal and measured concentrations:
- nominal: 100, 500, 1000, 1500, 2000 mg/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel: 24-multiwell plate with cover
- Fill volume: 2 mL/well
- Renewal rate of test solution (frequency/flow rate): batchwise renewal at 48 h after start of exposure)
- No. of organisms per vessel: 20 eggs/test group (1 egg/well)
- No. of vessels per concentration (replicates): 1 vessel/test group (20 wells/test group)
- No. of vessels per control (replicates): 1 vessel/control (20 wells/control)
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: dechlorinated Yokohama city tap water processed with an activated charcoal filter and sodium thiosulfate
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light/8 h dark
- Light intensity: 800 lux or less
EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Morphology of the embryo or larvae was assessed after 24, 48, 96 and 120 h. At the end of the test viable larvae were anesthetized with 1000 mg/L 2-phenoxyethanol and checked for morphological abnormalities. Mortality and hatching rate were assessed as well.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.3 - 5 - Reference substance (positive control):
- yes
- Remarks:
- sodium valproate (33.2 mg/L)
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 1 560 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 95% CI: 1380 - 1770 mg/L
- Duration:
- 120 h
- Dose descriptor:
- LC50
- Effect conc.:
- 1 220 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 95% CI: 1080 - 1340 mg/L
- Duration:
- 120 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 500 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- morphology
- Reported statistics and error estimates:
- The LC50 was derived by probit analysis. The NOEC was determined by Chi²-test (Yukms Statlight #5 software, Yukms Corp., Tokyo)
- Sublethal observations / clinical signs:
Table 1: Mortality
Test group [mg/L]
Cumulative number of dead
(mortality, %)
24 hpf
48 hpf
96 hpf
120 hpf
Control
0
(0)
0
(0)
0
(0)
0
(0)
Positive control
0
(0)
0
(0)
0
(0)
0
(0)
100
0
(0)
0
(0)
0
(0)
0
(0)
500
0
(0)
0
(0)
0
(0)
0
(0)
1000
0
(0)
0
(0)
2
(10)
4
(20)
1500
0
(0)
0
(0)
7
(35)
16
(80)
2000
0
(0)
0
(0)
17
(85)
20
(100)
Hpf: hours post fertilization
Table 2: Hatching rate
Test concentration [mg/L]
Number of hatching
Hatching rate [%]
Control
20
100
Positive control
20
100
100
20
100
500
20
100
1000
18
90
1500
18
90
2000
18
90
Table 3: Frequency of morphological abnormalites
Test concentration [mg/L]
Number of morphological assessments
Number of morphological abnormalities *1
Frequency of morphological abnormality *2
Control
20
2
10
Positive control
20
20
100
100
20
1
5
500
20
4
20
1000
15
15
100
1500
4
4
100
2000
-
-
-
*1: Surviving larvae were assessed
*2: Non-inflated swim bladder was not considered as morphological abnormalityTable 4: Results of the morphological assessment
Organs
Major parameters observed as abnormality
Positive control
Test substance
Body
Somite anomalies
Notochord anomalies
Fin anomalies
Somite anomalies
Notochord anomalies
Fin anomalies
Face/head
Lower jaw anomalies
-
Thoracic region
Pericardial edema
Heart anomalies
Pericardial edema
Abdominal region
Abdominal edema
Abdominal organ anomalies
Opaque intestinal tissue
Circlation
Blood circular anomalies
Heartbeat anomalies
Blood circular anomalies
Heartbeat anomalies
Referenceopen allclose all
Description of key information
LC50 (96 h): 1850 mg/L (nominal; OECD 203)
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 1 850 mg/L
Additional information
Two experimental studies are available investigating the short-term toxicity of ammonium undecafluorohexanoate (CAS 21615-47-4) to freshwater fish. The key study was performed according to OECD 203 (non-GLP) and the supporting study was performed according to OECD 236 (non-GLP).
Both studies were not performed in accordance with GLP since it was not initially performed for the purpose of a REACh registration but for other regulatory programs where the studies are not needed to be in compliance with GLP. Nevertheless, both studies were performed according to internationally accepted guidelines in a GLP accredited laboratory without any deviations to the guideline. Thus, the results are considered to be reliable and can be used for the hazard assessment. In the key study Oryzia latipes was exposed to nominal concentrations of 911, 1280, 1790, 2500, 3500 mg/L under static conditions for 96 h. The actual concentrations were analytically verified by HPLC/UV-VIS analysis and it was shown that the concentrations remained stable throughout the exposure. Geometric mean concentrations of 976, 1380, 1870, 2580, 3640 mg/L were determined. At the end of exposure a LC50 (96 h) of 1850 mg/L. The effect concentrations indicate that the substance will not cause mortality up to a limit concentration of 100 mg/L.
In the supporting study freshly fertilized eggs of Danio rerio were exposed to the test item up to 2000 mg/L in a semi-static testing regime. Morphological changes as well as mortality were recorded each 24 h up to 120 h of exposure. In accordance with the guideline the LC50 of 1560 mg/L after 96 h was used as key value. This effect concentration is in the same order of magnitude compared to the key study indicating low toxicity of the test item to fish.
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.
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