Registration Dossier
Registration Dossier
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: 217-565-6 | CAS number: 1888-91-1
- 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

Toxicity to aquatic algae and cyanobacteria
Administrative data
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 2017-11-20 to 2017-11-23 at the test facility
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-acetylhexanelactam
- EC Number:
- 217-565-6
- EC Name:
- N-acetylhexanelactam
- Cas Number:
- 1888-91-1
- Molecular formula:
- C8H13NO2
- IUPAC Name:
- 1-acetylazepan-2-one
- Test material form:
- liquid
- Details on test material:
- Batch: not yet known
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- All concentration levels and the control were analytically verified via HPLC-DAD at the start (0 hours) and at the end of the exposure (72 hours) with algae. The samples were analysed with an HPLC-DAD method.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- Stock solution, media preparation
100 mg test item/L was freshly prepared with dilution water (adjusted to pH 6.95). The dispersion was shaken until the solution was visually clear.
Test concentration
One limit concentration of 100 mg/L test item was tested. The concentration level is based on the results of a preliminary range finding test.
Control
Six replicates (without test item) were tested under the same test conditions as the test item replicates.
Test organisms
- Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: Pseudokirchneriella subcapitata HINDÁK
- Strain: SAG 61.81
- Source (laboratory, culture collection): SAG, Pflanzenphysiologisches Institut der Universität Göttingen, Nikolausberger Weg 18, D-37073 Göttingen
- Age of inoculum (at test initiation): A three day old preculture, prepared in dilution water, was used as inoculum.
- Method of cultivation: Fresh stocks were prepared every month on Z-Agar. Light intensity amounted to 2567 – 5130 lux corresponding to 35 - 70 µE ∙ m-2 ∙ s-1 for 24 h per day.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 72 h
- Post exposure observation period:
- No
Test conditions
- Hardness:
- Not specified
- Test temperature:
- min.: 22.0 max.: 23.0 mean value: 22.5
- pH:
- Geometric mean
measured test
item concentration pH-value
[mg/L] Start; 0 hours End; 72 hours
78.7 6.91 8.26
Control 6.94 8.34 - Dissolved oxygen:
- Not measured
- Salinity:
- Not measured, freshwater conditions
- Details on test conditions:
- TEST SYSTEM
- Test vessel: 250 mL Erlenmeyer flasks
- Type (delete if not applicable): open, cotton wool plugs
- Material, size, headspace, fill volume: sterile 250 mL Erlenmeyer flasks, test volume 100 mL
- Aeration: Test containers were placed on a rotary shaker and oscillated at appr. 70 rpm
- Type of flow-through (e.g. peristaltic or proportional diluter): None
- Renewal rate of test solution (frequency/flow rate): One application at test start
- Initial cells density: Nominal: approximately 2 - 5 x 10^3 cells/mL, Actual: mean 6839 cells/mL
- Control end cells density: Mean 2799975 cells/mL
- No. of vessels per concentration (replicates): 6
- No. of vessels per control (replicates): 6
GROWTH MEDIUM
- Standard medium used: yes
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:
Composition of Dilution Water
according to the guideline
Component Concentration [mg/L]
NH4Cl 15
MgCl2 x 6 H2O 12
CaCl2 x 2 H2O 18
MgSO4 x 7 H2O 15
KH2PO4 1.6
FeCl3 x 6 H2O 0.064a2EDTA x 2 H2O 0.1
H3BO3 0.185
MnCl2 x 4 H2O 0.415
ZnCl2 3 x 10^-3
Na2MoO4 x 2 H2O 7 x 10^-3
CoCl2 x 6 H2O 1.5 x 10^-3
CuCl2 x 2 H2O 1 x 10^-5
NaHCO3 50
pH 8.1 ± 0.2
This medium had a nominal hardness of 0.24 mmol Ca+Mg/L. The pH value was adjusted to 6.95 with 1 M HCl and 1 M NaOH one day before the experimental starting. The pH value was checked at the experimental starting and doesn’t has to adjusted again.
OTHER TEST CONDITIONS
- Sterile test conditions: no
- Adjustment of pH: no
- Photoperiod: 24 h
- Light intensity and quality: Approximately 4440 to 8880 lux, corresponding to 60 to 120
µE ∙ m-2 ∙ s-1, mean value: 5956 lux,
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
-Chlorophyll a-fluorescence
The cell density was measured daily via Chlorophyll a-fluorescence, excitation at 436 nm, emission at 685 nm. Dilution water was used as a background signal. Self-fluorescence was observed in the saturated solution. A separate replicate of each test item concentration were prepared without algae and treated like the other test replicates. The self-fluorescence of each measuring point was taken into account in the evaluation. - Reference substance (positive control):
- yes
- Remarks:
- (Potassium dichromate)
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 78.7 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Effect conc.:
- > 78.7 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- > 78.7 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC20
- Effect conc.:
- > 78.7 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 78.7 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 78.7 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- other: Inhibition of Yield
- Key result
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Effect conc.:
- > 78.7 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- other: Inhibition of Yield
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- > 78.7 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- other: Inhibition oy Yield
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC20
- Effect conc.:
- > 78.7 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- other: Inhibition of Yield
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 78.7 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- other: Inhibition of Yield
- Details on results:
- - Exponential growth in the control (for algal test): yes
- Observation of abnormalities (for algal test):
- Unusual cell shape: No
- Colour differences: No
- Flocculation: No
- Adherence to test vessels: No
- Aggregation of algal cells: No
- Other: The limit concentration was visually clear throughout the exposure period.
- Effect concentrations exceeding solubility of substance in test medium: No - Results with reference substance (positive control):
- The toxicity of potassium dichromate (SIGMA-ALDRICH, batch number MKBV0900V, purity 99.0 %, CAS RN 7778-50-9) to the unicellular freshwater green alga Pseudokirchneriella subcapitata was determined over a period of 72 hours from 2017-10-10 to 2017-10-13. The reference item toxicity is in the valid range following test facility SOPS.
EC50-Values of the Reference Item
based on nominal concentrations mg/L, (0-72 hours)
Current Study Valid Range (average ± 3 x SD)
Growth Rate inhibition
ErC50 0.535 0.745 ± 0.524
95 % confidence interval 0.523 – 0.547
Yield inhibition
EyC50 0.320 0.398 ± 0.291
95 % confidence interval 0.249 – 0.339
SD = Standard deviation - Reported statistics and error estimates:
- EC-values and statistical analyses
EC-values of the growth rate and yield inhibition were estimated empirically based on the results of the only treatment level (Limit test design).
NOEC and LOEC values
NOEC/LOEC were determined by calculation of statistical significance of growth rate and yield. As a standard, a t-test was used for NOEC/LOEC calculations. When running a t-test, a Normality test and an Equal Variance test were done first. The SHAPIRO-WILK-Test was used to test for normal distribution of data. The Levene median test was used for equal variance. P-values for both Normality and Equal Variance tests are 0.05. The -value (acceptable probability of incorrectly concluding that there is a difference) is =0.05.
Software
The data for the tables in this report are computer-generated and have been rounded for presentation from the full derived data. Consequently, if calculated manually based on the given data minor deviations may occur from these figures.
Calculations were carried out using software
• Excel, MICROSOFT CORPORATION
• SigmaPlot, SPSS INC.
Any other information on results incl. tables
Cell Densities
Geometric mean measured test item concentration |
Replicate |
Cell density [cells/mL] |
|||
[mg/L] |
No. |
0 hours |
24 hours |
48 hours |
72 hours |
78.7 |
1 |
6839 |
32219 |
463096 |
2420239 |
2 |
6839 |
27535 |
412734 |
2711786 |
|
3 |
6839 |
30004 |
430699 |
2529086 |
|
4 |
6839 |
31256 |
355782 |
2546291 |
|
5 |
6839 |
31025 |
458812 |
2226304 |
|
6 |
6839 |
28977 |
438424 |
2816244 |
|
Mean |
6839 |
30169 |
426591 |
2541658 |
|
Control |
1 |
6839 |
27772 |
350398 |
2768140 |
2 |
6839 |
33565 |
381718 |
2856213 |
|
3 |
6839 |
27125 |
320214 |
2259953 |
|
4 |
6839 |
40772 |
518994 |
3068875 |
|
5 |
6839 |
33542 |
465015 |
3246483 |
|
6 |
6839 |
30235 |
391257 |
2600188 |
|
Mean |
6839 |
32169 |
404599 |
2799975 |
Evaluation after 72 hours
Statistically significant differences of growth rates and yield compared to control values are marked (+), not significant differences are marked (-).
Geometric mean measured test item concentration |
Replicate |
Growth rate |
Growth rate inhibition |
Yield |
Inhibition of yield |
||
[mg/L] |
No. |
[d-1] |
[%] |
[cells/mL] |
[%] |
||
78.7 |
1 |
|
1.96 |
2 |
|
2413400 |
14 |
2 |
|
1.99 |
0 |
|
2704947 |
3 |
|
3 |
|
1.97 |
2 |
|
2522247 |
10 |
|
4 |
|
1.97 |
1 |
|
2539452 |
9 |
|
5 |
|
1.93 |
4 |
|
2219465 |
21 |
|
6 |
|
2.01 |
0 |
|
2809405 |
-1 |
|
Mean |
(-) |
1.97 |
2 |
(-) |
2534819 |
9 |
|
Control |
1 |
|
2.00 |
|
|
2761301 |
|
2 |
|
2.01 |
|
|
2849374 |
|
|
3 |
|
1.93 |
|
|
2253114 |
|
|
4 |
|
2.04 |
|
|
3062036 |
|
|
5 |
|
2.05 |
|
|
3239644 |
|
|
6 |
|
1.98 |
|
|
2593349 |
|
|
Mean |
|
2.00 |
|
|
2793136 |
|
Negative inhibition = increase of growth
Section-by-Section and Average Specific Growth Ratesof the Control Group (0 - 72 hours)
|
Replicate No. |
Specific growth rate [d-1] |
Mean (0 - 72 hours) |
SD ± |
CV |
Mean CV [%] |
||
section-by-section |
||||||||
0 - 24 hours |
24 - 48 hours |
48 - 72 hours |
||||||
Control |
1 |
1.40 |
2.54 |
2.07 |
2.00 |
0.570 |
28.5 |
25.4 |
2 |
1.59 |
2.43 |
2.01 |
2.01 |
0.420 |
20.9 |
||
3 |
1.38 |
2.47 |
1.95 |
1.93 |
0.546 |
28.2 |
||
4 |
1.79 |
2.54 |
1.78 |
2.04 |
0.440 |
21.6 |
||
5 |
1.59 |
2.63 |
1.94 |
2.05 |
0.528 |
25.7 |
||
6 |
1.49 |
2.56 |
1.89 |
1.98 |
0.542 |
27.4 |
||
|
|
|
Mean |
2.00 |
|
|
||
|
|
|
SD ± |
0.04 |
|
|||
|
|
|
CV [%] |
2.13 |
|
SD = Standard deviation CV = Coefficient of variation
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- In this study, no inhibition of growth on the freshwater green alga Pseudokirchneriella subcapitata was found after 72 hours exposure to the test item N-acetylhexanelactam. The EC50-values for inhibition of growth rate (ErC50) and yield (EyC50) after 72 hours were > 78.7 mg/L, respectively. The NOEC-values for inhibition of growth rate and yield after 72 hours were 78.7 mg/L, respectively.
All effect values given are based on geometric mean measured test item concentrations of N-acetylhexanelactam.
- Executive summary:
The toxicity of N-acetylhexanelactam to the unicellular freshwater green alga Pseudokirchneriella subcapitata was determined according to the principles of OECD 201 and Council Regulation (EC) No. 266/2016/Method C.3 from2017-11-20 to 2017-11-23 at the test facility.The aim of the study was to assess the effects on growth rate and yield over a period of 72 hours.
The study was conducted under static conditions with an initial cell density of 6839 cells/mL. A stock solutionwith a nominal
loading of 100 mg test item/L was tested. Six replicates were used for the limit concentration and the control. The environmental conditions were within the acceptable limits.
The concentration of the test item N-acetylhexanelactam was analytically verified via HPLC-DAD at the start of the exposure (0 hours) and at the end of the exposure (72 hours) in the limit concentration and the control.
The measured concentration of the test item at the start of the exposure (0 hours) was 100% of the nominal value. The measured concentrations at the end of the exposure (72 hours) was 62% of the nominal value. The geometric mean measured concentration was 78.7 mg/L.
All effect values were based on the geometric mean measured test item concentration of the test item N-acetylhexanelactam.In this study, no inhibition of growth on the freshwater green alga Pseudokirchneriella subcapitata was found after 72 hours exposure to the test itemN-acetylhexanelactam.The results are summarized in the following table:
NOEC, LOEC, EC - valuesofN-acetylhexanelactam(0-72hours)
based on the geometric mean measured test concentration [mg/L]
Inhibition of Growth Rate
NOEC
78.7
LOEC
>78.7
ErC10
>78.7
ErC20
>78.7
ErC50
>78.7
Inhibition of Yield
NOEC
78.7
LOEC
>78.7
EyC10
>78.7
EyC20
>78.7
EyC50
>78.7
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.

EU Privacy Disclaimer
This website uses cookies to ensure you get the best experience on our websites.