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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 212-811-9 | CAS number: 871-78-3
- 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:
- 2008-05-29 to 2008-06-02
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- N,N'-ethylenedi(diacetamide)
- EC Number:
- 212-811-9
- EC Name:
- N,N'-ethylenedi(diacetamide)
- Cas Number:
- 871-78-3
- Molecular formula:
- C6H12N2O2
- IUPAC Name:
- N-(2-acetamidoethyl)acetamide
- Reference substance name:
- Diacetylethylenediamine (DAED)
- IUPAC Name:
- Diacetylethylenediamine (DAED)
- Details on test material:
- - Name of test material (as cited in study report): N,N'-Diacetylethylenediamine (DAED)
- Physical state: solid (powder)
- Analytical purity: 99.9 %
- Composition of test material, percentage of components: 99.9 % (w/w) DAED; 0.05 % (w/w) water; 0.09 % (w/w) acetic acid; < 0.01 % (w/w) ethylene diamine
- (Purity test date) Date ofcertificate of analysis: 2008-05-21
- Lot/batch No.: 14-016
- Expiration date of the lot/batch: 2010-05-21
- Stability under test conditions: Stable (ca. 0.1 % aqueous solution)
- Storage condition of test material: Room temperature, protected from moisture and light
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- Details on properties of test surrogate or analogue material (migrated information):
PHYSICO-CHEMICAL PROPERTIES
- Melting point: 170 - 172 °C
- Water solubility (under test conditions): Soluble, > 1 g/L
- log Kow: -1 (measured)
- Stability in water: stable (ca. 0.1 % aqueous solution)
OTHER PROPERTIES (if relevant for this endpoint)
- Density: 400 - 500 g/L (bulk density, 20 °C)
- pH: 4-6 (1 g/L, 20 °C)
- TOC: 50 %
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 1000 mg/L
- Sample storage conditions before analysis: 6 +/- 2 °C, if necessary
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test medium (1000 mg/L) was mixed with an ultraturrax (1 min, 12000 rpm).
- Differential loading: 1000 mg/L
- Controls: Dilution water without test item
- Evidence of undissolved material (e.g. precipitate, surface film, etc): The test item was clearly dissolved.
Test organisms
- Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: Danio rerio (zebrafish)
- Source: AQUARIUM AM AEGI, Volgersweg 6, D-30175 Hannover
- Length at study initiation (mean): 2.71 cm
- Weight at study initiation (mean): 0.19 g
- Method of breeding: Holding was performed at the test facility at 23 +/- 2 °C and diffuse light (0.1-10 µmol photons x m-2 x s-1, natural photoperiod). Tap water of local origin was used for holding and testing. The water was filtered on activated charcoal and aerated for at least 24 h to remove chlorine. Nominal water parameters: Total hardness: 10 - 250 mg CaCO3/L; pH-value: 6.0 - 8.5. The water is analysed biannual acc. to German tap water regulation. The water was changed at least once per week. The dissolved oxygen concentration was more than 80 % of the air saturation value.
- Feeding during test: no feeding during the test
ACCLIMATION
- Acclimation period: Zebrafish with at least 12 days of acclimatisation and mortality < 5 % within these days before the study starts were used in the test.
- Acclimation conditions (same as test or not): same
- Type and amount of food: 4 % of the fish body weight per feeding day. The test fish were not fed 24 h before the test started. Food: Stör perlets; SERA GMBH, D-52518 Heinsberg
- Feeding frequency: 3 times per week
- Health during acclimation (any mortality observed): No disease treatments were administered throughout holding and testing.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Post exposure observation period:
- No
Test conditions
- Hardness:
- Total hardness of the water was determined at the beginning out of the test control to be 54 mg/L as CaCO3.
- Test temperature:
- During the test the room temperature was recorded continuously with a thermohygrograph. Temperature was measured in all vessels at the beginning of the test and every 24 h to be:
Day Concentration [mg/L] Temperature [°C]
0 1000 24.0
Control 24.0
1 1000 24.0
Control 24.0
2 1000 23.2
Control 23.2
3 1000 23.5
Control 23.9
4 1000 23.7
Control 24.0 - pH:
- pH-value was measured in all vessels at the beginning of the test and every 24 h to be:
Day Conc. pH-Value
[mg/L]
0 1000 7.55
Control 7.61
1 1000 7.67
Control 7.68
2 1000 7.71
Control 7.69
3 1000 7.65
Control 7.64
4 1000 7.38
Control 7.35 - Dissolved oxygen:
- Oxygen saturation was measured in all vessels at the beginning of the test and every 24 h to be:
Day Conc. Oxygen-Saturation
[mg/L] [%]
0 1000 100
Control 100
1 1000 100
Control 100
2 1000 100
Control 100
3 1000 99
Control 95
4 1000 95
Control 96 - Salinity:
- Nor measured
- Nominal and measured concentrations:
- 1000 mg/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): open, loosely covered by glass tops
- Material, size, headspace, fill volume: Glass-aquaria
- Aeration: Gentle aeration
- Renewal rate of test solution (frequency): One application at test start
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: less than 1 g fish per liter test solution
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Tap water of local origin, pH-value: 6.0 - 8.5.
- Total organic carbon: 10 - 250 mg CaCO3/L
- Chlorine: The dilution water was filtered on activated charcoal and aerated for at least 24 h to remove chlorine
- Culture medium different from test medium: No
- Intervals of water quality measurement: The water is analysed biannual acc. to German tap water regulation.
OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: natural photoperiod
- Light intensity: 0.1 - 10 µmol photons x m-2 x s-1
EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Observations were made after 24, 48, 72 and 96 h. Fish were considered dead if there was no visible movement (e.g. gill covers movement) and if touching of the caudal peduncle produced no reaction. Records were kept of visible abnormalities (e.g. loss of equilibrium, swimming behaviour, respiratory function, pigmentation, etc.).
TEST CONCENTRATIONS
- Spacing factor for test concentrations: limit test - Reference substance (positive control):
- no
Results and discussion
Effect concentrations
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 1 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- - Behavioural abnormalities: Not observed
- Mortality of control: 0 %
- Other adverse effects control: Not observed
- Abnormal responses: Not observed
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: Not observed
- Effect concentrations exceeding solubility of substance in test medium: No - Reported statistics and error estimates:
- The concentration leading to 0 % mortality (LC0) after 96 h was determined directly from the test results. LC50-values have not to be calculated in a limit test.
Any other information on results incl. tables
- Sublethal observations / clinical signs:
Observations in the Test Vessels:
Nominal test item Concentration [mg/L]
Effect*)
Test Duration [h]
24
48
72
96
1000
(1)
7/7
7/7
7/7
7/7
Control
(1)
7/7
7/7
7/7
7/7
*) The number in brackets correspond to the following observation: (1) = normal behaviour
Cumulative Mortality [%] in the Test Vessels:
Nominal test item Concentration [mg/L]
Test Duration [h]
24
48
72
96
1000
0
0
0
0
Control
0
0
0
0
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- In this study N,N' -Diacetylethylenediamine (DAED) did not cause any effects to zebrafish after 96 h when tested with a nominal test item concentration of 1000 mg/L. The NOEC (0 – 96 h) is laid down as 1000 mg/L.
- Executive summary:
The acute toxicity of the test item N,N' -Diacetylethylenediamine (DAED)(Batch no.: 14-016) to fish (zebrafish) was determined according to OECD-Guideline for Testing of Chemicals No. 203 (1992) from 2008-05-29 to 2008-06-02 at Dr.U.Noack-Laboratorien, 31157 Sarstedt, Germany. A static limit test was conducted with a single test item concentration of 1000 mg/L. Duration of the test was 96 h. 7 test organisms were exposed to the test concentration and control. Water quality parameters pH-value, temperature and oxygen-saturation measured after 0, 24, 48, 72 and 96 h were determined to be within the acceptable limits. The limit concentration of N,N' -Diacetylethylenediamine (DAED) and control were analysed at test start and test end via HPLC analysis. The acute toxicity of the test item N,N' -Diacetylethylenediamine (DAED) is summarised in the following table:
Table 1: LC-Values with 95 % Confidence Intervals (nominal concentration)
Test duration [h]
LC50
p = 95 %
24
> 1000 mg/L
not applicable
48
> 1000 mg/L
not applicable
72
> 1000 mg/L
not applicable
96
> 1000 mg/L
not applicable
LC100 =
> 1000 mg/L
Lowest test item concentration
with 100 % mortality after 96 h
LC0 =
1000 mg/L
Highest test item concentration
with 0 % mortality after 96 h
NOEC (0-96 h) =
No observed effect concentration
1000 mg/L
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.