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EC number: 485-320-2 | CAS number: 221667-31-8
- 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
Toxicity to aquatic plants other than algae
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to aquatic plants other than algae
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 Jan - 04 Feb 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 221 (Lemna sp. Growth Inhibition Test)
- Version / remarks:
- (draft)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 850.4400 (Aquatic Plant Toxicity Test using Lemna spp. Tiers I & II))
- Qualifier:
- according to guideline
- Guideline:
- other: FIFRA Guideline 123-2
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Nominal concentrations: 0 (Control), 6.25, 12.5, 25.0, 50.0 and 100 mg a.i./L.
- Sampling method: Samples of AE 0001789 Technical test solutions, including controls, were taken on Day 0 (new solutions), Day 3 (new solutions) and on Day 7 (old solutions) to measure actual exposure concentrations of AE 0001789 Technical. On Days 0 and 3 the test solutions were prepared as uniform batches. On these days a 260 mL aliquot of the uniform test solution was poured into each of the labeled test vessels. Approximately 10 mL of the remaining, fresh prepared, test solution was then collected for analysis at each concentration. On Day 7, a portion of the old test solutions from all replicates within a test concentration was composited. Approximately 10 mL of the composite sample was collected for measured concentration analysis at each test level. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: All of the test solutions were prepared as 2 L uniform batches. The high concentration test solution (100 mg a.i./L) was prepared by adding approximately 0.206 g of the AE 0001789 (97.4% a.i.) technical to approximately 1000 mL of 20XAAP media in a 2-L volumetric flask. The flask was shaken vigorously for 1 minute, followed by 30 minutes of sonication. The flask was then brought to a volume of 2 L and allowed to stir overnight (approximately 16 hours). The following day the remaining test solutions (50.0, 25.0, 12.5 and 6.25 mg a.i./L) were prepared using a 50% serial dilution procedure from the high concentration. Each concentration was prepared by adding 1000 mL of the next higher concentration to a 2-L volumetric flask and then bringing it to volume (2 L) with 20XAAP media and inverting several times. The control solution consisted of 20XAAP media only. No solvent was used to prepare any of the test solutions. Solutions were prepared in similar fashion for the day 3 renewal.
- Test concentration separation factor: 2 - Test organisms (species):
- Lemna gibba
- Details on test organisms:
- TEST ORGANISM
- Common name: Duckweed
- Strain: Lemna gibba G3
- Source: own culture, originally optained from the United States Department of Agriculture Fruit Laboratory, Beltsville, Maryland on June 3, 2004 and from the University of Minnesota, St. Paul, Minnesota on October 30, 2003. The two cultures were combined to form a single culture which was maintained in the laboratory and used to initiate this study.
- Age of inoculum (at test initiation): not stated in report but the density of the Lemna used in the definitive study was documented to verify that the cultures were in log phase growth at test initiation.
- Method of cultivation: Lemna culture techniques were based on those described by ASTM (2004). The cultures were renewed at least once per week.
ACCLIMATION
- Acclimation period: 14 days - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 7 d
- Hardness:
- soft water
- Test temperature:
- 25 ± 2.0 °C
- pH:
- 7.7 - 9.0
- Dissolved oxygen:
- -
- Salinity:
- -
- Conductivity:
- 1491 - 1603 µmhos/cm (mean: 1541 µmhos/cm)
- Nominal and measured concentrations:
- Nominal concentrations: 0 (Control), 6.25, 12.5, 25.0, 50.0 and 100 mg a.i./L.
Mean measured concentrations:- Details on test conditions:
- TEST SYSTEM
- Incubation chamber used: yes
- Test vessel:
- Material, size, headspace, fill volume: 650-ml borosilicate glass crystallization dishes filled with approximately 260-ml of test solution.
- Type of cover: terile, petri dish lids
- Renewal rate of test solution: on day 3
- No. of fronds per colony: 13
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 3
GROWTH MEDIUM
- Standard medium used: yes
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: according to guideline
- Intervals of water quality measurement: on day 0, 3 and 7
OTHER TEST CONDITIONS
- Sterile test conditions: yes
- Adjustment of pH: No
- Photoperiod: 24 hours light
- Light intensity and quality: 500 ± 10% foot-candles (5.4 klux).
EFFECT PARAMETERS MEASURED: Growth was determined by frond counts on days 0, 3, 5 and 7.
- Determination of frond number: manual counting
- Determination of biomass: Dry weight (The plants from each replicate were dried at approximately 60 °C for at least 24 hours, transferred to a desiccator to cool to ambient temperature, and then weighed to determine the dry weight (± 0.1 mg).)
- Other: Phytotoxicity observations were performed to determine the health of the plants in each test vessel.
RANGE-FINDING STUDY
- Test concentrations: 0.1, 1.0, 10 and 100 mg a.i./L with a control
- Results used to determine the conditions for the definitive study: The result was an inhibition in frond number, compared to the control, of -10, 7, 4 and 37 percent for the 0.1, 1.0, 10 and 100 mg a.i./L test concentrations, respectively. Inhibition in growth as determined by day 7 frond dry weights was-7, 11, 5 and 22 percent for the 0.1, 1.0, 10 and 100 mg a.i./L test concentrations, respectively.- Duration:
- 7 d
- Dose descriptor:
- EC50
- Effect conc.:
- > 104 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- frond number
- Duration:
- 7 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 51.1 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- frond number
Results:
Test Object
Lemna gibba G3
Exposure
7-Day, static -renewal
7- day EyC50 - frond count
>104 mg a.i./L
7- day ErC50 - growth rate for frond numbers
>104 mg a.i./L
7- day ErC50 - cumulative biomass for frond numbers
>104 mg a.i./L
7- day EyC50- frond dry weight
>104 mg a.i./L
7- day ErC50 - growth rate for frond dry weight
>104mga.i./L
Lowest Concentration With an Effect (LOEC)
104 mg a.i./L (frond counts, and
growth rate and cumulative
biomass for frond counts)
Highest Concentration Without Toxic Effect (NOEC)
51.1 mg a.i./L (frond counts,
and growth rate and cumulative
biomass for frond counts)
72.9 mga.i./L(frond counts,
and growth rate and cumulative
biomass for frond counts)
Toxic Threshold Effect Concentration, TEC (Geometric
mean of NOEC and LOEC)
Observations: Fronds in all levels appeared normal as compared to the control.
Conclusion:
The NOEC and LOEC in the 7-day exposure of Lemna gibba G3 to AE 0001789 Technical were 51.1 and 104 mg a.i./L (mean measured) for the endpoints of frond counts, cumulative biomass and growth rate for frond counts, respectively. The EC50 for all endpoints measured was >104 mg a.i./L which was the highest concentration tested.
Table 1: Measured Test Concentrations of AE 0001789 Technical During the Exposure of Lemna gibba G3
Nominal
Conc.
(mg ai/L)
Day 0
Measured
Conc.
(mg a.i./L)
Day 0
Percent
Nominal*
Day 3 (new)
Measured
Conc.
(mg ai/L)
Day 3 (new)
Percent
Nominal*
Day 7
Measured
Conc.
(mg ai/L)
Day 7
Percent
Nominal*
Mean
Measured
Conc.
(mg ai/L)
Mean
Measured
Percent
Nominal*
Control
<0.31
-
<0.31
-
<0.31
-
<0.31
-
6.25
6.21
99
6.19
99
5.62
90
6.01
96
12.5
12.4
99
12.5
100
11.0
88
12.0
96
25.0
25.0
100
24.8
99
22.8
91
24.2
97
50.0
52.7
105
52.3
105
48.4
97
51.1
102
100
104
104
102
102
105
105
104
104
LOQ = 0.31mga.i./L
* 'Percent Nominal' calculations were made using unrounded data. Manual calculations using rounded data may vary slightly.
Table 2: Validity criteria for OECD 221 (2006)
Criterion from the guideline
Outcome
Validity criterion fulfilled
The doubling time of frond number in the control must be less than 2.5 days (60 h), corresponding to approximately a seven-fold increase in seven days and an average specific growth rate of 0.275 d-1.
The doubling time of frond number in the control group during the 168 hour test was 1.65 days or
approximately 40 hours.
yes
- Validity criteria fulfilled:
- yes
- Remarks:
- See Table 2 in "Any other information on results incl. tables".
Reference
Description of key information
NOEC (7 d): 51.1 mg a.i./L (arith. mean measured, Lemna gibba, OECD 221)
EC50 (7 d): >104 mg a.i./L (arith. mean measured, Lemna gibba, OECD 221)
Key value for chemical safety assessment
- EC50 for freshwater plants:
- 104 mg/L
- EC10 or NOEC for freshwater plants:
- 51.1 mg/L
Additional information
One study on the effects of the test substance to aquatic plants is available (M-251602-01-1). The study was conducted in accordance with the prevailing OECD testing guideline (OECD 221) under GLP conditions. Measured test concentrations were within 96 - 104% of nominal. Based on measured concentrations, the NOEC in the 7-day exposure of Lemna gibba to the test substance was 51.1 mg a.i./L, for frond number, biomass and growth rate for frond counts, respectively. The EC50 for all endpoints measured was >104 mg a.i./L (arith. mean measured) which was the highest concentration tested. Fronds in all levels appeared normal as compared to the control.
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