Registration Dossier

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1997-06-10 to 1997-07-17
Reliability:
1 (reliable without restriction)
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Version / remarks:
December 1992
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Version / remarks:
April 1984
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Lithium Hydroxide monohydrate;
- Physical state: solid;
- Analytical purity: LiOH 55.2 %

Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
NA

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Concentrations: nominal: 4.6; 10; 21; 46; 100 mg/L;
measured: 19.64; 43.90; 99.20 mg/L (with pH adjustment); 9.58; 19.86; 44.80 (without pH adjustment);
- Sampling method: For the analytical measurements of the test substance concentrations, duplicate samples from the freshly prepared test media of all test concentrations of both test series (with and without pH-adjustment) and the control were taken just before the start of the test.
- Sample storage conditions before analysis: All samples were deep-frozen (-20 degree C) immediately after sampling. All samples are kept stored at about -20 degree C to enable additional analysis.

Test solutions

Vehicle:
no
Details on test solutions:
- Before start of the test, two concentrated stock solutions were prepared. At each stock solution 1000 mg of test substance were dissolved in 100 mL bidistilled water, resulting in a nominal concentration of 10 g/L. At one stock solution, the pH was adjusted to pH 7.9 with 2 mol HCl, at the other stock solution the pH was not adjusted. Then, adequate volumes of both intensively stirred stock solutions were mixed into the test water to obtain the desired test concentrations. At one series of test media the pH was adjusted, at the other series not. This allowed to differentiate if a toxic effect is caused due to a pH-effect of the substance with strong basic pH, or if it is a real toxic effect of Lithium (-hydroxide).
- The same five following test substance concentrations were tested in both experimental parts (with and without pH-adjustment): 4.6, 10, 21, 46 and 100 mg/L. Additionally, a control was tested in parallel (test water without addition of test substance). The test media were prepared just before introduction of Daphnia (= start of the test).

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
- The study was performed with young test animals of a clone of the species Daphnia magna Straus. The clone was originally supplied by the University of Sheffield/UK in 1992, defined from the supplier as clone 5. Since this date the clone is bred in the laboratories of RCC under similar temperature and light conditions as in the test, and in reconstituted water of similar quality regarding to pH, components of the main ions and total hardness as the test water used in the test.

Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Post exposure observation period:
NA

Test conditions

Hardness:
250.0 mg/L as CaCO3
Test temperature:
20 degree C
pH:
without pH-adjustment: 8.9 at 4.6 mg/L to 11.2 at 100 mg/L;
with pH-adjustment: 7.9 to 8.1 at all concentrations;
Dissolved oxygen:
without pH-adjustment: 8.5 - 8.9 mg/L;
with pH-adjustment: 8.4 - 8.8 mg/L;
Salinity:
NA
Nominal and measured concentrations:
nominal: 4.6; 10; 21; 46; 100 mg/L;
measured: 19.64; 43.90; 99.20 mg/L (with pH adjustment); 9.58; 19.86; 44.80 (without pH adjustment);
Details on test conditions:
TEST SYSTEM
In each test concentration and the control, 20 Daphnia were tested, divided into two groups of ten animals, each group in 50 mL test medium in a 100-mL glass beaker. The test vessels were labelled with the RCC Project number and all necessary additional information to assure unmistakable identification. The test was performed in an air-temperated room.


TEST MEDIUM / WATER PARAMETERS
- Reconstituted water: In bidistilled water analytical grade salts were added to following nominal concentrations, and the water was aerated to oxygen saturation:
- CaCl2x2 H2O: 2.0 mmol/L (= 294.0 mg/L)
- MgSO4x7 H2O: 0.5 mmol/L (= 123.0 mg/L)
- NaHCO3: 0.75 mmol/L (= 65.0 mg/L)
- KCl: 0.075 mmol/L (= 5.8 mg/L)
- Water Hardness: 2.5 mmol/L (= 250 mg/L) as CaCO3
- Ratio of Ca:Mg = 4:1 (based on molarity)
- Ratio of Na:K = 10:1 (based on molarity)


OTHER TEST CONDITIONS
- Adjustment of pH: one stock solution to pH 7.9 with 2 mol HCl;
- Photoperiod: 16 hrs light to 8 hrs darkness;
- Light intensity: between 200 and 1200 Lux;
- The Daphnia were not feed, and the test media were not aerated during the test period;


EFFECT PARAMETERS MEASURED:
- The immobility or mortality of the Daphnia was determined by visual control after 24 and 48 hours. Those animals not able to swim within 15 seconds after gentle agitation of the test beaker were considered to be immobile.


TEST CONCENTRATIONS
- The test concentrations were based on a range-finding test. The range finding test was not performed in compliance with GLP-Regulations, but the raw data of the range-finding test will be archived under the RCC Project number of the present study.
Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
29.4 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
LiOH anhydrous; without pH-adjustment
Basis for effect:
mobility
Remarks on result:
other: 95% CL: 25.4 to 34.0 mg/L
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
19.1 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
LiOH anhydrous; without pH-adjustment
Basis for effect:
mobility
Remarks on result:
other: 95% CL: 15.1 to 24.1 mg/L
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
76.8 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
LiOH anhydrous; with pH-adjustment
Basis for effect:
mobility
Remarks on result:
other: 95% CL: 63.6 to 92.8 mg/L
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
34.3 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
LiOH anhydrous; with pH-adjustment
Basis for effect:
mobility
Remarks on result:
other: 95% CL: 29.6 to 39.7 mg/L
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
6.3 mg/L
Nominal / measured:
nominal
Conc. based on:
other: calculated for Lithium hydride without pH adjustment
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
11.4 mg/L
Nominal / measured:
nominal
Conc. based on:
other: calculated for Lithium hydride with pH adjustment
Basis for effect:
mobility
Details on results:
The analytically determined test substance concentrations in the analysed test media varied in the range from 93.5 % to 103.2 % of the nominal values. In the test media the test substance concentrations were constant during the test period of 48 hours. Therefore, all reported biological results are related to the nominal concentrations of the test substance.
During the test period, the dissolved oxygen concentrations in the test media were at least 8.3 mg/L or higher. The pH-value in the freshly prepared test media without pH-adjustment ranged from pH 8.9 at the test concentration of 4.6 mg/L to pH 11.2 at 100 mg/L. At the end of the test period the pH-values had decreased to pH 8.0 - 8.7. The pH-value in the test media with pH-adjustment ranged from pH 7.9 to 8.1.

Test media without pH-adjustment:
In the control and in the test media without pH-adjustment up to and including the test concentration of nominal 10 mg test substance/L no immobility or mortality of the test animals or other signs of intoxication were determined during the test period of 48 hours.
The 24-hour EC 50 of the test substance was calculated to be 29.4 mg test substance/L with 95 % confidence limits from 25.4 to 34.0 mg/L. The 24-hour EC 0 was 10 mg test substance/L, the 24-hour EC 100 amounted to 46 mg test substance/L.
After 48 hours of exposure the toxicity of the test substance to Daphnia magna had further increased. The 48-hour EC 50 was calculated to be 19.1 mg test substance/L with 95 % confidence limits from 15.1 to 24.1 mg/L. The 24-hour EC 0 and also the 48-hour NOEC (highest concentration tested without toxic effects after 48 hours) of Lithium Hydroxide was 10 mg test substance/L, since no significant immobilization rate and no other signs of intoxication were observed at the test animals up to and including this test concentration. The 48-hour EC 100 amounted to 46 mg test substance/L.

Test media with pH-adjustment:
In the test media with pH-adjustment the toxic effect of the test substance (Note: The test substance in the experimental part with pH-adjustment is LiCl instead of LiOH due to the pH-adjustment by means of HCl. The toxic effects are caused with high possibility by the Lithium-ion) was slightly lower compared to the effects without pH-adjustment. Thus a part of the toxic effect of Lithium Hydroxide was obviously caused due to the strong basic pH.
The 24-hour EC 50 of the test substance (see above) after pH-adjustment to approximately pH 8 was calculated to be 76.8 mg/L with 95 % confidence limits from 63.6 to 92.8 mg/L. The 24-hour EC 0 was 21 mg/L, the 24-hour EC 100 amounted to > 100 mg/L.
The 48-hour EC 50 was calculated to be 34.3 mg/L with 95 % confidence limits from 29.6 to 39.7 mg/L. The 48-hour EC 0 and also the 48-hour NOEC (highest concentration tested without toxic effects after 48 hours) of the test substance after the pH-adjustment was 21 mg/L. The 48-hour EC 100 amounted to 46 mg/L.
In the test media with pH-adjustment no remarkable observations were made concerning the appearance of the test substance in the test media.
In the test media without pH-adjustment a small precipitate was observed at the test concentrations of 21 and 46 mg/L at the bottom of the testbeakers at the observations after 24 and 48 hours. At 100 mg/L the freshly prepared test media were turbid, and the precipitate was observed after 24 and 48 hours at the bottom and also at the medium surface. However, as the good recoveries of the analytical results demonstrate this was not the test substance which precipitated. Thus, it was possibly a precipitate out of the test water caused by the high pH-values.
Reported statistics and error estimates:
No statistics performed

Any other information on results incl. tables

Information on results incl. tables see attached document.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
Lithium Hydroxide (55.2 %) was tested for short term aquatic toxicity in Daphnia in an 48-hour static test according to EU Method C.2 and OECD Guideline 202. Without pH-adjustment the 48 hour EC 50-value was 19.1 mg/L. With pH-adjustment the 48-hour EC 50-value 34.3 mg/L for Lithium hydroxide anhydrous. Based on read across approach, the calculated EC50 without pH-adjustment for Lithium hydride was 6.3 mg/L and with pH-adjustment 11.4 mg/L.
Executive summary:

The acute toxicity of the test substance Lithium Hydroxide (55.2 %) to Daphnia magna was determined in a 48-hour static test according to the EU method Annex Part C.2 and the OECD Guideline No. 202. The nominal concentrations tested were 4.6, 10, 21, 46 and 100 mg test substance/L, and in parallel a control. At one series of test media the pH was adjusted to approximately pH 8 by HCl, at the other series not. This allowed to differentiate if a toxic effect is caused due to a pH-effect of the test substance with a strong basic pH, or if it is a real toxic effect of Lithium(-hydroxide). The analytical determined test substance concentrations in the analysed test media varied in the range from 93.5 % to 103.2 % of the nominal values. In the test media the test substance concentrations were constant during the test period of 48 hours. Therefore, all reported biological results are related to the nominal concentrations of the test substance. Without pH-adjustment the 48 hour EC50-value was 19.1 mg/L and with pH-adjustment the 48-hour EC50-value 34.3 mg/L for Lithium hydroxide anhydrous. Based on read across approach, the calculated EC50 without pH-adjustment for Lithium hydride was 6.3 mg/L and with pH-adjustment 11.4 mg/L.