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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 606-384-1 | CAS number: 19797-08-1
- 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
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 Apr - 03 May 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- no
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Remarks:
- UPLC
- Details on sampling:
- - Concentrations: Control and all test concentrations at test start (0 h) and test end (48 h)
- Sampling method: 2.0 mL from the approximate centre of the test vessels. At the end of the exposure period, the replicates were pooled at each concentration before sampling. Additionally, reserve samples of 2.0 mL were also taken.
- Sample storage conditions before analysis: Freezer (≤ - 15 °C) for a maximum of three monthes after delivery of the draft report - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Test item: The test item was a colourless to pale yellow liquid with a purity of 99.57% and completely soluble in the test medium at the concentrations tested. No correction was made for the purity/composition of the test item.
- Method of preparation: First, the 100 mg/L test solution was prepared by application of approximately 15 min magnetic stirring for acceleration of the dissolution process of the test item in the test medium. Lower concentration were prepared by subsequent dilutions of the limit concentration in test medium.
- Differential loading: No
- Controls: Test medium without test item
- Evidence of undissolved material: All test solutions were clear and colorless at the end of the preparation procedure. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Waterflea
- Source: In-house laboratory culture with known history
- Age of parental stock: 2nd to 5th brood
- Age of daphnia at test start: < 24 h from parental daphnids of more than 2 weeks old
- Breeding: Approximately 250 newborn daphnids (< 3 d old) were placed in 5 L culture medium in an all-glass culture vessel. After 7 d of cultivation, half of the medium was renewed twice a week; Maximum age of cultures: 4 weeks; Temperature of medium: 18 - 22 °C; Culture medium: M7, according to Elendt-Schneider (Elendt, B.P. 1990, Protoplasma 154, 25-33)
- Feeding during Breeding: A suspension of freshwater algae, administered daily.
- Feeding during test: No feeding during test
ACCLIMATION
- Acclimation period: None. Daphnids were introduced 15 min after preparation of the test solutions. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
- Hardness:
- 180 mg/L CaCO3 (test medium)
- Test temperature:
- 19 - 21 °C
- pH:
- Control: 8.0 (0 h), 8.4 (48 h)
Limit concentration: 8.0 (0 h), 8.3 (48 h) - Dissolved oxygen:
- Control: 8.9 mg/L (0 h), 9.4 mg/L (48 h)
Limit concentration: 8.9 mg/L (0 h), 9.4 mg/L (48 h) - Nominal and measured concentrations:
- Control and 100 mg/L (nominal)
Control and 88 - 91 mg/L (measured) - Details on test conditions:
- TEST SYSTEM
- Test vessel: 60 mL all-glass vessels filled with 50 mL test solution
- Aeration: No aeration of the test solutions
- No. of organisms per vessel: 5 per vessel
- No. of vessels per concentration (replicates): 4 (limit concentration) and 2 (range-finder concentrations)
- No. of vessels per control (replicates): 4
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: The test medium was prepared in tap water purified by Reverse Osmosis (RO-water, GEON Waterbehandeling, The Netherlands)
- Culture medium different from test medium: Culture medium (M7, Elendt 1990) different from test medium (ISO medium, according to guideline).
- Intervals of water quality measurement: pH and dissolved oxygen were measured at the begining (0 h) and at the end of the test (48 h) in the control and limit concentration. The temperature of the medium was continuously measured in a temperature contol vessel.
OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 h light, 8 h dark
EFFECT PARAMETERS MEASURED:
- Immobility (including mortality): 24 h and 48 h
RANGE-FINDING STUDY
- Test concentrations: 0.10, 1.0 and 10 mg/L (from combined limit/range-finding test)
- Results used to determine the conditions for the definitive study: Yes - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate (K2Cr2O7)
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- - Behavioural abnormalities: No
- Mortality of control: 0%
- Any observations 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):
- - Results with reference substance valid?
Yes, the results were within the expected range and in agreement with historical in-house data.
- EC50 (48 h) = 0.33 mg/L (95% CI: 0.29 - 0.38 mg/L).
- Other: The reference test dates from 19 - 21 Mar 2018 and was performed according to OECD testing guideline 202 using potassium dichromate (K2Cr2O7) as reference substance. - Reported statistics and error estimates:
- The EC50 could not be calculated because no effects were observed.
- Validity criteria fulfilled:
- yes
- Remarks:
- For further details please refer to “Any other information on results incl. tables”.
Reference
VALIDITY CRITERIA
The study fulfilled the validity criteria defined by the testing guideline (Table 1) and is thus considered reliable and valid.
Table 1: Validity criteria for OECD 202.
Criterion from the guideline |
Outcome |
Validity criterion fulfilled |
In the control, including the control containing the solubilising agent, not more than 10% of the daphnids should have been immobilized. |
No mortality or any other signs of (sub-lethal) toxicity were observed in the control. |
Yes |
The dissolved oxygen concentration at the end of the test should be ≥ 3 mg/L in control and test vessels. |
The dissolved oxygen concentration was ≥ 3 mg/L at the end of the test in control and test vessels. |
Yes |
ANALYTICAL RESULTS
The measured test item concentration in the limit concentration was 88 – 91% of nominal throughout the exposure period. Thus, effect parameters were expressed in terms of the analytically confirmed nominal concentration.
BIOLOGICAL RESULTS
No immobility was observed in the control and at any of the test concentrations throughout the exposure period, resulting in an EC50 (48 h) of > 100 mg/L.
Description of key information
Not acutely toxic to aquatic invertebrates. EC50 (48 h) >100 mg/L (nominal).
Key value for chemical safety assessment
Additional information
One study investigating the acute toxicity of N-ethylcaprolactam to
aquatic invertebrates is available. The study was conducted according to
OECD 202 at static test conditions with Daphnia magna. The test animals
were exposed to a limit concentration of 100 mg/L for 48 hours. The test
substance concentration was analytically verified via Ultra Performance
Liquid Chromatography (UPLC). The measured test concentration was 88 –
91% of the nominal test concentration. Thus,
the effect concentration was based on the nominal test concentration. No
immobilisation or behavioural abnormalities were observed in the course
of the test. The determined EC50 (48 h) was >100 mg/L (nominal).
Based on the results of the acute toxicity testing N-ethylcaprolactam is
considered not acutely toxic to aquatic invertebrates.
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.