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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 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:
- 23 Apr - 24 May 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- 1992
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Remarks:
- UPLC
- Details on sampling:
- - Concentrations: Control and limit concentration at t = 0 h and t = 96 h
- Sampling method: 2.0 mL from the approximate centre of the test vessels
- Sample storage conditions before analysis: Samples were stored in a freezer (≤ -15 °C). Storage stability of the sampels was demonstrated in project 20144279. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: A stock solution of 100 mg/L test item was prepared by application of 15 min magnetic stirring to accelerate dissolution in the test medium. Lower test concentrations were prepared by subsequent dilution of the highest 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):
- Cyprinus carpio
- Details on test organisms:
- TEST ORGANISM
- Common name: Carp
- Source: Zodiac, proefacc, "De Haar Vissen", Wageningen University and Research Centre, The Netherlands
- Age at study initiation: F1
- Length at study initiation: 2.4 ± 0.3 cm
- Weight at study initiation: 0.16 ± 0.09 g
- Growth stage and method of breeding: F1 from a single parent-pair bred in UV-treated water.
ACCLIMATION
- Acclimation period: At least 12 d after delivery
- Acclimation conditions: ISO medium with comparable water quality parameters, pH and temperature
- Health during acclimation: In the batch of fish used for the test, mortality during the 7 d prior to the start of the test was < 5%.
FEEDING
- Feeding during test: No feeding from 24 h prior test and during entire test.
- Feeding during holding: Daily feeding with pelleted fish food (Essence 300 - 500 µm, Coppens International bv, Helmond, The Netherlands) - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Hardness:
- 180 mg/L CaCO3 (ISO medium)
- Test temperature:
- Control: 20.7 - 21.1°C
Treatment: 20.7 - 21.1°C - pH:
- Control: 7.7 - 8.0
Treatment: 7.5 - 8.0 - Dissolved oxygen:
- Control: 7.2 - 9.1 mg/L
Treatment: 6.0 - 9.1 mg/L - Nominal and measured concentrations:
- Control and 100 mg/L (nominal)
Control and 82% of nominal (measured) - Details on test conditions:
- TEST SYSTEM
- Test vessel: 6.5 L all-glass container filled with 5 L test solution
- Aeration: The test media were not aerated during the test.
- No. of organisms per vessel: 7 per test group
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.22 g fish/L (7 fish per 5 L of test medium)
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Adjusted ISO medium prepared in tap water purified by Reverse Osmosis (RO-Water, GEON Waterbehandeling)
- Culture medium different from test medium: Culture medium same as test medium.
- Intervals of water quality measurement: Conductivity, pH, nitrite and ammonia concentration: once a week. Temperature: continuous. In addition, pH and temperature were measured before transferring the fish to the test system.
OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 h light, 8 h dark
EFFECT PARAMETERS MEASURED:
- Mortality and effects: At 2.75, 24, 48, 72 and 96 h. In addition, every afternoon vessels were checked for dead or severly distressed fish.
- Dissolved oxygen, pH and temperature: Daily in all vessels with surviving fish
TEST CONCENTRATIONS
- Range finding study : Yes,
- Test concentrations: 0.1 to 100 mg/L with a spacing factor of 10
- Results used to determine the conditions for the definitive study: Yes. No mortality or other clinical effects were observed at any of the test concentrations. The measured concentration at the start of the test was 83 mg/L and remained stable (i.e. 91 - 104% relative to initial). Therefore, the expected LC50 was above 83 mg/L. - Reference substance (positive control):
- yes
- Remarks:
- Pentachlorophenol
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- - Behavioural abnormalities: No
- Mortality of control:0%
- Effect concentrations exceeding solubility of substance in test medium: No - Results with reference substance (positive control):
- - Results with reference substance valid? Yes
- LC50 (96 h) = 0.15 mg/L PCP (95% CI 0.1 - 0.22 mg/L)
- Other: The reference test was performed from 19 - 23 Mar according to OECD 203. - Reported statistics and error estimates:
- No LC50 could be calculated because the test item was non-toxic (LC50 > maximum concentration).
- Sublethal observations / clinical signs:
VALIDITY CRITERIA
The study fulfilled the validity criteria defined by the OECD guideline and is thus considered reliable and valid.
Table 1: Validity criteria for OECD 203.
Criterion from the guideline
Outcome
Validity criterion fulfilled
The mortality in the control(s) should not exceed 10% (or one fish if less than ten are used) at the end of the test
Mortality in the control was 0%.
Yes
The dissolved oxygen concentration must have been at least 60 per cent of the air
saturation value throughout the test
The dissolved oxygen concentration was ≥ 60% of the air saturation throughout the test (> 5 mg/L at 22 °C).
Yes
There must be evidence that the concentration of the substance being tested has been satisfactorily maintained, and preferably it should be at least 80 per cent of the
nominal concentration throughout the test. If the deviation from the nominal
concentration is greater than 20 per cent, results should be based on the measured
concentration.
The measured test item concentrations were at least 80% of nominal throughout the test.
Yes
ANALYTICAL RESULTS
The measured concentration in the limit concentration was 82% of nominal at the beginning and end of the test. Based on this result, the effect parameters were expressed in terms of the analytically confirmed nominal concentration.
BIOLOGICAL RESULTS
After 96 h, no mortality or other clinical effects were observed at the limit concentration throughout the test, resulting in an LC50 (96 h) > 100 mg/L (nominal).
- Validity criteria fulfilled:
- yes
- Remarks:
- For further details please refer to “Any other information on results incl. tables”.
Reference
Description of key information
Not acutely toxic to fish. LC50 (96 h) >100 mg/L (nominal).
Key value for chemical safety assessment
Additional information
The acute toxicity of N-ethylcaprolactam to fish was determined in a
study according to OECD 203. Fish of the species Cyprinus carpio were
exposed to a test substance concentration of 100 mg/L in a static limit
test. The test substance concentration was analytically verified via
Ultra Performance Liquid Chromatography (UPLC). The recovery rate was
82% of the nominal test concentration. Thus, the effect
concentration was based on the nominal test concentration. No
mortalities or symptoms of intoxication were observed during the 96 h
test period. The determined LC50 (96 h) was >100 mg/L (nominal).
Based on the results of the acute toxicity testing N-ethylcaprolactam is
considered not acutely toxic to fish.
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