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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 700-835-7 | CAS number: 919005-14-4
- 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
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03 December 2007 - 07 December 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study conducted under GLP. Study on ammonium salt.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EEC directive 92/96, Part C, PubNo. L383, C.1: ISO International Standard 7346-1
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- ADONA
- IUPAC Name:
- ADONA
- Details on test material:
- - Name of test material (as cited in study report): MTDID 6675
- Substance type: single-constituent substance
- Physical state: clear colorless liquid
- Analytical purity: 30.3 ±0.0% in water
- Lot/batch no.: 140499-19/10
- Stability under test conditions: Stable in water at least 96 hours
- Storage condition of test material: At room temperature in the dark
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling method: 5 mL aliquots were taken at 0h and 96h from all test concentrations and controls
- Sample storage conditions before analysis: Stored in freezer until analysis
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
Method: ADONA consists of 30.3% active ingredient (a.i.) in water. The lower concentrations were prepared by subsequent dilutions of the highest test concentration (3340 mg/L total product in test medium). No special treatment other than a 10 min of magnetic stirring was necessary to completely dissolve the test substance in the test medium.
- Controls: Test medium without test substance or other additives
- Evidence of undissolved material (e.g. precipitate, surface film, etc): None, final test solutions were all clear and colorless.
Test organisms
- Test organisms (species):
- Cyprinus carpio
- Details on test organisms:
- TEST ORGANISM
- Common name: Carp
- Strain: Linnaeus, 1758
- Source: Zodiac, proefacc, "De Haar Vissen", Wageningen University and Research Centre, The Netherlands
- Age at study initiation (mean and range, SD): Not reported
- Length at study initiation (length definition, mean, range and SD): 2.4 ± 0.2 cm
- Weight at study initiation (mean and range, SD): 0.39 ± 0.10 g
- Feeding during test: No feeding from 24 hours prior to the test and during the total test period
ACCLIMATION
- Acclimation period: 12 days after delivery
- Acclimation conditions (same as test or not): same as test
- Type and amount of food: Pelleted fish food (Nutra 3.0 T, TROUW NUTRITION, Putten, The Netherlands)
- Feeding frequency: Daily
- Health during acclimation (any mortality observed): Mortality during seven days prior to the start of the test was less than 5%
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
Test conditions
- Hardness:
- 180 mg/L CaCO3
- Test temperature:
- 21.8 - 22.9 °C
- pH:
- 7.3 - 7.9
- Dissolved oxygen:
- 6.5 - 9.1 mg/L
- Nominal and measured concentrations:
- Nominal concentration for the total product: 334, 600, 1067, 1867 and 3340 mg/L
Corresponds to analytically confirmed nominal concentration of the active ingredient: 101, 182, 323, 566 and 1012 mg a.i./L - Details on test conditions:
- TEST SYSTEM
- Test vessel: 10L all-glass tanks, 9.5 L fill volume
- Aeration: Introduced after 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: 0.29 g fish/L
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Water used to prepare media was tap water purified by reverse osmosis; GEON waterbehandeling, Berkel-Enschot, The Netherlands
- Culture medium different from test medium: No, Adjusted ISO medium used for both
- Intervals of water quality measurement: pH, nitrate, nitrite and ammonia concentrations were measured once a week.Termperature measured every day. In addition, pH and temperature were measured before transferring the fish to the test system.
OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 light: 8 dark
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mortality was recorded at 2.5, 24, 48, 72 and 96 hours. In addition, every afternoon from day 0 and every morning from day1 to observe for any dead or severely distressed fish.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.8
- Range finding study: No - Reference substance (positive control):
- yes
- Remarks:
- Pentachlorophenol (PCP)
Results and discussion
Effect concentrations
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 1 012 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: ADONA induced no visible or lethal effects at or below 1012 mg a.i./L (corresponding to 3340 mg/L total product).
- Details on results:
- Measured concentrations are shown in Table 1. Analysis of the highest concentration showed that measured concentrations of the active ingredient were stable and in agreement with nominal concentrations during the 96h test period.
Mortality results are shown in Table 2.
- Behavioural abnormalities: None noted
- Observations on body length and weight: None noted
- Other biological observations: No mortality or clinical effects were observed
- Mortality of control: 0
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: No
- Effect concentrations exceeding solubility of substance in test medium: No - Results with reference substance (positive control):
- 96h LC50 of 0.15 mg/L, 95% confidence of 0.10 - 0.22 mg/L. This is in agreement with the historical 96h LC50 range of 0.10 - 0.46 mg/L for carp exposed to PCP. Historical data of reference test were preformed every 3 months from April 1988 until the end of 2000, and annually since then.
- Reported statistics and error estimates:
- No LC50 could be calculated because the test substance proved to be non-toxic (LC50 > maximum concentration tested).
Any other information on results incl. tables
- Sublethal observations / clinical signs:
Table 1 Concentrations of the ADONA in test medium
Time of sampling
(hours)
ConcentrationA
Nominal
(mg/L)
Analyzed
(mg/L)
Relative to nominal
(%)
Relative to initial (%)
0
0
<0.08
n.a.B
1012
969
96
96
0
<0.08
n.aB
1012
986
97
102
A) Concentrations were for the active ingredient and were corrected for its purity (30.3%)
B) Not applicable
Table 2 Incidence of mortality and total mortality
ConcentrationA
ADONA
(mg/L)
Initial
Number
of fish
Cumulative mortality
Total
Mortality
(%)
2.5h
24h
48h
72h
96h
Control
7
0
0
0
0
0
0
101
(334)
7
0
0
0
0
0
0
182
(600)
7
0
0
0
0
0
0
323
(1067)
7
0
0
0
0
0
0
566
(1867)
7
0
0
0
0
0
0
1012
(3340)
7
0
0
0
0
0
0
A) Analytically confirmed nominal concentration of active ingredient.
Nominal concentrations within parentheses for total product.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Remarks:
- No mortality in controls throughout test. Test conditions constant throughout test. Dissolved oxygen concentration > 5 mg/L. Measured concentrations ≥ 80% of nominal concentration throughout test.
- Conclusions:
- ADONA induced no visible or lethal effects at or below 1012 mg/L for the active ingredient (corresponding to 3340 mg/L total product).
- Executive summary:
DONA is an acid with pKa ca.2 and will be entirely dissociated in aquatic systems. Aquatic toxicity testing would require neutralization of stock solutions, and DONA would in practice be testing of a neutral salt. This test examined the ammonium salt of DONA (ADONA).
The toxicity of ADONA to carp, Cyprinus carpio, was assessed in a 96-hour toxicity test conducted according to the OECD 203 (1992) method.
The 96-hour LC50 of ADONA to Cyprinus carpio was > 1012 mg/L active ingredient, corresponding to 3340 mg/L total product. Analysis of the highest concentration showed that measured concentrations were stable and in agreement with nominal concentrations during the 96h test period, therefore the effect parameter referenced the nominal concentrations.
The study was performed in accordance with internationally-accepted test guidelines and Good Laboratory Practice (GLP) standards. Therefore, use of this study for DONA is reliable with restrictions and the results are suitable for purposes of Risk Assessment, Classification & Labeling, and PBT Analysis.
Result Synopsis
Test type: Static (based on data obtained using OECD 203 methodology)
96-hr LC50 > 1012 mg/L active ingredient (3340 mg/L total product)
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.