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EC number: 211-519-9 | CAS number: 657-27-2
- 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:
- 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
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: “VI Acute Toxicity Study with Fish” in the “On Test Methods of New Chemical Substances” (Nov 21, 2003, Yakushoku No. 1121002, Heisei 15-11-13 Seikyoku No. 2, Kanhoki No. 031121002)
- GLP compliance:
- yes
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
- Storage condition of test material: Dark and cool place
Constituent 1
Constituent 2
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- The sample for analysis was collected with no replicate from mid layer of each test vessel without agitation.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- The test solution was prepared by weighing 0.4995 g of the test substance (0.5000 g in terms of active ingredient), washing it with dilution water into a vessel, further diluting with the dilution water to make final volume of 1 L, and thoroughly being agitated with a Teflon rod. The test solution was prepared for the first time at the initiation of the study, and thereafter, every time the dilution water was renewed (every 24h).
Test organisms
- Test organisms (species):
- Oryzias latipes
- Details on test organisms:
- TEST ORGANISM
- Common name: Japanese killifish
- Strain: Oryzias latipes
- Source: Matsuoka Suisan (Shiga Prefecture)
- Average total length: 3.0 cm (2.7-3.1 cm), n = 20, (At the completion of exposure)
- Average body weight: 0.22 g (0.18-0.25 g), n = 20, (At the completion of exposure)
ACCLIMATION
- Acclimation period: 98 days (Nov. 26, 2007 - Mar. 03, 2008)
- Acclimation conditions (same as test or not): yes
- Type and amount of food: TetraMin (Tetra Japan). Approx. 2 % of the body weight of the fish/day. None was fed from 48 hours before exposure start.
- Feeding frequency: daily
- Health during acclimation (any mortality observed): The mortality for the period of 7 days before the initiation of exposure was less than 5 %. Only fish apparently in good health was used for the study.
Study design
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Remarks on exposure duration:
- A preliminary study was conducted by using two nominal concentration levels of 10 and 100 mg a.i. /L. The mortality at 96 h of exposure was 0 % and no toxic signs were observed even at the highest concentration of 100 mg a.i./L .
Test conditions
- Test temperature:
- 23 ± 2˚C
- pH:
- 7.6-7.8
- Dissolved oxygen:
- 6.7-8.4 mg/L
- Nominal and measured concentrations:
- Nominal: 100 mg/L
Average measured: 103 mg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: Aquarium
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume: glass, 21 x 16 x 23 H cm, 5L
- Aeration: no (At least 60 % of air saturation value was maintained)
- Renewal rate of test solution (frequency/flow rate): Batch-wise renewal of the test solutions every 24 hour
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Dechlorinated water (Municipal water of Takarazuka-City, which was treated with activated charcoal to eliminate any residual chlorine and adequately aerated) was used as dilution water.
- for more details see the below attachment
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours light, 8 hours dark.
- Light intensity:Indoor lighting
TEST CONCENTRATIONS
- Range finding study: yes
- Test concentrations: 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: The mortality at 96 hours of exposure was 0 % and no toxic signs were observed even at the highest concentration of 100 mg a.i./L. Based on the above results, it was decided to conduct the definitive study as a limit study using one concentration level of 100 mg a.i. /L. - Reference substance (positive control):
- yes
- Remarks:
- copper sulfate (II) pentahydrate
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 24 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 103 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 48 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 103 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 72 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 103 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 103 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Results with reference substance (positive control):
- - Results with reference substance valid? yes
- LC50: 2.3 mg/L.
- Other: sensitivity confirmation study was conducted every 6 month or for every lot
Any other information on results incl. tables
- Sublethal observations / clinical signs:
Cumulative Mortality (%) of Oryzias latipe sand Toxic Signs at Each Observation Time
Nominal conc.
(mg a.i./L)
No. of organisms
Item
Duration of exposure
3 hours
6 hours
24 hours
48 hours
72 hours
96 hours
Non-treated control
10
Cum. mortality (%)
Toxic sign
0
NA:10
0
NA:10
0
NA:10
0
NA:10
0
NA:10
0
NA:10
100
10
Cum. mortality (%)
Toxic sign
0
NA:10
0
NA:10
0
NA:10
0
NA:10
0
NA:10
0
NA:10
Note: NA: No abnormalities
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- 96 h median lethal concentrations (LC50) of L-lysine hydrochloride for Japanese Killifish (Oryzias latipes) was >103 mg a.i./L (based on the average measured concentration).
- Executive summary:
The acute toxicity of L-lysine hydrochloride to Oryzias latipes (1 replicate/concentration, 10 fish/concentration) was assessed in a semi-static test according to OECD 203. The nominal test concentration was 100 mg/L. Measured concentrations in freshly prepared and used (24h after the test solution was prepared) ranged between 99% and 103% of nominal.The LC50 was >103 mg/L, based on averaged measured concentrations.
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