Lysine hydrochloride

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

04/03/2008-06/03/2008

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

Report date:

2008

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: “V Acute Immobilization Test with Water Flea” in “On Test Methods of New Chemical Substances” (November 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

Test material information

Constituent 1

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

Constituent 2

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
- Stability under test conditions: stable
- Other: confirmation of identity: IR spectrum of the test substnce was confirmed to fully correspond to the one provided by the sponsor

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

Samples were taken from fresh solutions at 0 and 24 hours, and from spent solutions at 24 and 48 hours.

Test solutions

Vehicle:

no

Details on test solutions:

A weighed amount of the test substance was added to dilution water and dissolved by agitation. The test solution was renewed after 24 hours.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia
- Strain: Daphnia magna
- Source: National Institute for Environmental Studies, Japan
- Age at study initiation (mean and range, SD): no more than 24 h old
- Feeding during test: none


ACCLIMATION
- Acclimation period: 12/02/2008 - 04/03/2008
- Acclimation conditions (same as test or not): same as test
- Type and amount of food: monocellular green alga Chlorella vulgaris (concentrated raw chlorella liquid, commercially available), 0.1-0.2 mg C (content of organic carbon)/daphnia (adjusted as appropriate depending on the proliferative status)
- Feeding frequency: daily
- Health during acclimation (any mortality observed): Mortality of the parrents was ) 0%, no abnormalities such as generation of dormant eggs were observed and the proliferation status was in good order

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Post exposure observation period:

No post exposure observations.

Test conditions

Hardness:

250 mg/L (in terms of CaCO3)

Test temperature:

20 ± 1°C

pH:

7.8 - 8.1

Dissolved oxygen:

8.7 - 8.8 mg/L

Salinity:

no data

Nominal and measured concentrations:

100 mg/L (nominal); mean measured concentration 106 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass beaker of 100 mL capacity
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume: 100 mL/vessel
- Aeration: None
- No. of organisms per vessel: 20 daphnids/test concentration (5 daphnids/vessel x 4 reps)
- No. of vessels per concentration (replicates): 4 replicates/test concentration
- No. of vessels per control (replicates): 4 replicates


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted water Elendt M4

OTHER TEST CONDITIONS
- Adjustment of pH: Not adjusted
- Photoperiod: 16 hours light, 8 hours dark.
- Light intensity: 576 - 1048 lux


TEST CONCENTRATIONS

- Justification for using less concentrations than requested by guideline: Prior to the initiation of definitive test, a preliminary test was conducted by using two concentration levels of 10 and 100 mg /L. However, no effects, what so ever, were observed even at the highest concentration. Therefore, it was decided to conduct the definitive test as a limit test using only one concentration level of 100 mg /L
- Test concentrations: 100 mg/L

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

> 106 mg/L

Nominal / measured:

meas. (arithm. mean)

Basis for effect:

mobility

Effect concentrations 2

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 106 mg/L

Nominal / measured:

meas. (arithm. mean)

Basis for effect:

mobility

Results with reference substance (positive control):

Study conducted separately; EC50 was 0.96 mg/L (historical data: 0.75 ± 0.10 mg/L). Sensitivity was thus confirmed.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The EC50 of L-lysine hydrochloride to daphnia magna was >106 mg/L, based on mean measured concentrations.

Executive summary:

The acute toxicity of L- lysine hydrochloride to Daphnia magna(< 24 old, 4 replicates/concentration, 5 daphnids/replicate) was assessed in a semi- static test according to OECD 202. The nominal test concentration was 100 mg/L. Measured concentrations in freshly prepared solutions (0 and 24 hours) and 24- hour spent solutions (24 and 48 hours) ranged between 105 and 108% of nominal.The EC50 was >106 mg/L, based on mean measured concentrations.