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EC number: 211-519-9 | CAS number: 657-27-2
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 20/02/2008 - 27/03/2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed according to the OECD guidelines and according to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: "IV Growth Inhibition test with Algae" (modified Nov 20,2006) in the Annex to "On Test Methods of New Chemical Substances" (Nov 21,2003, Yakushoku No.1121002, Heisei 15-11-13, Seikyoku No.2, Kanhoki No. 031121002)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Lysine hydrochloride
- EC Number:
- 211-519-9
- EC Name:
- Lysine hydrochloride
- Cas Number:
- 657-27-2
- Molecular formula:
- C6H14N2O2.ClH
- IUPAC Name:
- lysine hydrochloride
- Reference substance name:
- L-lysine hydrochloride
- EC Number:
- 233-234-9
- EC Name:
- L-lysine hydrochloride
- Cas Number:
- 10098-89-2
- IUPAC Name:
- L-lysine hydrochloride
- Details on test material:
- - Name of test material (as cited in study report): L-lysine hydrochloride
- Analytical purity: 100.1%
- Lot/batch No.: 070039
- Expiration date of the lot/batch: April 25, 2008
- Stability under test conditions: Stability was confirmed by comparing the IR spectrum at the begining and end of the test
- Storage condition of test material: Dark and cool place
Constituent 1
Constituent 2
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 100 mg/L
- Sampling method: For the determination of the test substance concentration in the test solution, samples were taken at 0; 24; 48 and 72 h from the mid layer of each vessel. The algal bodies were removed by centrifugation (1750xg, 10 min) and the aqueos phase analysed by HPLC. For counting of algal cells, 2 mL of the test solutions from each test vessel was mixed with 18 mL (or 19 mL) of electrolyte solution (ISOTON II) followed by determination using a particle counter.
- Sample storage conditions before analysis: not mentioned
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: 100 mg/L was prepared by weighing 0.0799 g of the test substance (0.0800 g as active ingredient) with an electronic balance, washing it with medium into a vessel which had been partially filled with medium, and further diluting it with remaining amount of the medium to make a final volume of 800 mL.
- Eluate: OECD recommended medium
- Controls: included; non-treated controls
Test organisms
- Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: Monocellular green algae
- Source (laboratory, culture collection): ATCC2262
Study design
- Test type:
- other: open system (with a breathable silicone stopper) and shake cultures (100 rpm)
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 72 h
- Post exposure observation period:
- not mentioned
Test conditions
- Hardness:
- not mentioned
- Test temperature:
- 20.7-21.2C
- pH:
- pH at test initiation= 7.6-7.9
pH at test completion=8.3 - Dissolved oxygen:
- not mentioned
- Salinity:
- not mentioned
- Nominal and measured concentrations:
- Nominal concentration: 100 mg/L
Measured concentrations:
101 mg/L at t=0h
99.4 mg/L at t=24h
102 mg/L at t=48h
99.6 mg/L at t=72h - Details on test conditions:
- TEST SYSTEM
- Test vessel: Glass Erlenmeyer falsk of 300 mL
- Type (delete if not applicable): open system (with a breathable silicone stopper) and shake culture (100 rpm)
- Initial cells density: 10000 cells/mL
- Control end cells density: 1324000 cell/mL
- No. of vessels per concentration (replicates): 6
- No. of vessels per control (replicates): 6
GROWTH MEDIUM
- Standard medium used: yes
OTHER TEST CONDITIONS
- Sterile test conditions: yes
- Adjustment of pH: not mentioned
- Photoperiod: continuous
- Light intensity and quality: fluorescent lamp of 400-700 nm; photon flux density 60-120 µE/m2/s ± 15% (near surface of the solution)
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
EC50 (0-72h) and NOEC (0-72h)
TEST CONCENTRATIONS
- Results used to determine the conditions for the definitive study: In the limit test, no significant differences were detected in the growth rates (0-72 h) of either 10 mg/L or 100 mg/L when compared to that on the non-treated control. Therefore, the definitive test was conducted at 100 mg/L. - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 72 h
- Dose descriptor:
- other: ErC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- other: NOECr
- Effect conc.:
- 100 mg/L
- Basis for effect:
- growth rate
- Results with reference substance (positive control):
- - Results with reference substance valid?
- ErC50 (0-72h): 0.92 mg/L. Sensitivity confirmation tests had been conducted every 6 month
- Other: Background data (February 2007 - October 2007) were 1.2 - 1.5 mg/L (n = 2 ).
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The ErC50 of L-lysine hydrochloride to Pseudokirchneriella subcapitata was > 100 mg/L and NOECr was 100 mg/L, based on mean measured concentrations.
- Executive summary:
The acute toxicity of L-lysine hydrochloride to Pseudokirchneriella subcapitata (6 replicates/concentration, intial biomass 1 x 104cells/mL) was assessed according to OECD 201. The nominal test concentration was 100 mg/L. Measured concentrations of the test substance in the test solutions during the exposure period were well maintained, i.e. within range of 99 - 102 % of the nominal value. Average measured concentration during the exposure period was 100 mg /L. The ErC50 (0 -72h) was >100 mg/L and NOECr (0 -72h) was 100 mg/L.
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