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Ecotoxicological information

Short-term toxicity to fish

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Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
- Concentrations: stability test at 10 and 100 mg/L
- Sampling method: the samples were taken from the test solution at 1, 24, 48, 72 and 96 h.
Vehicle:
no
Test organisms (species):
Oryzias latipes
Details on test organisms:
TEST ORGANISM
- Common name: Oryzias latipes
- Age at study initiation (mean and range, SD): 3-4 months
- Length at study initiation (length definition, mean, range and SD): 2.0 ± 1 cm

FEEDING DURING TEST
- Fasted for 24 h immediately prior to exposure.
- No feed was provided during the test.
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
Mantained at 10-250 mg/L as CaCO3.
Test temperature:
23.2 - 23.9 ºC
pH:
7.13 - 7.97
Dissolved oxygen:
5.2 - 8.5 mg/L
Nominal and measured concentrations:
100 mg/L (nominal)
Details on test conditions:
TEST SYSTEM
- Aeration: No
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: tap water was passed through a membrane filter (1 µm) to remove particulate matter and through an activated carbon filter to remove the residual chlorine or organic substances.
- Chlorine: below 0.01 mg/L

OTHER TEST CONDITIONS
- Photoperiod: 16 h light / 8 h dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : The fish were observed daily for abnormality and mortality.
The criteria of death employed in this study were the absence of respiratory movement and response to external stimulation.


TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 0.1, 1, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: no mortality or adverse effects were observed at 100 mg/L.
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Key result
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Reported statistics and error estimates:
Statistical analysis was not performed and the 50% lethal concentration (LC50) values were expressed as greater than 100 mg/L because no mortality was observed.
Validity criteria fulfilled:
not specified
Conclusions:
Based on the results, the 96-h-LC50 of calcium hydrogenorthophosphate in Oryzias latipes was above 100 mg/L (nominal) and the NOEC was 100 mg/L, both based on mortality.
Executive summary:

A short-term toxicity test on fish was performed with calcium hydrogenorthophosphate according to OECD Guideline 203, under GLP conditions. In accordance with a range-finding preliminary study, a limit test was performed with Daphnia magna at 100 mg/L of test item and one control group in a static system. A stability test was performed during test at nominal concentrations of 10 and 100 mg/L. Seven fish per group were exposed to the test item or the control for 96 h. The analysis of the test solution was performed at 1, 24, 48, 72 and 96 h using inductively coupled plasma (ICP). Based on the results, the 96-h-LC50 of the test item in Oryzias latipes was above 100 mg/L (nominal) and the NOEC was 100 mg/L, both based on mortality.

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
1992 version
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Wako Pure Chemical Industries, Ltd., Lot No.: PAR1681.
- Purity: 100.2%
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 100 mg/L
- Sampling method: at the start of the test, before medium replacement (48 h) and at the end of the test (96 h).
Vehicle:
yes
Remarks:
dechlorinated industrial water
Test organisms (species):
Oryzias latipes
Details on test organisms:
TEST ORGANISM
- Common name: Oryzias latipes
- Age at study initiation (mean and range, SD): not described
- Length at study initiation (length definition, mean, range and SD): 2.1 cm (1.8 - 2.3 cm)
- Weight at study initiation (mean and range, SD): 0.17 g (0.13 - 0.22 g)

Test type:
flow-through
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
Total hardness (as CaCO3): 30 mg/L
Test temperature:
24 ± 1 ºC
pH:
7.8
Nominal and measured concentrations:
Nominal: 100 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: 3 l glass beaker
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: 3 L
- Aeration: None
- Renewal rate of test solution (frequency/flow rate): 5 times a day
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

OTHER TEST CONDITIONS
- Photoperiod: 16 hours light / 8 hours dark

TEST CONCENTRATIONS
- Test concentrations: 100 mg/L

Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Key result
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Validity criteria fulfilled:
not specified
Conclusions:
Based on the results, the 96h-LC50 of choline chloride in Oryzias latipes was higher than 100 mg/L (nominal), based on mortality.
Executive summary:

A short-term toxicity test on fish was performed with choline chloride according to OECD Guideline 203 (1992 version), following GLP. A limit test was performed using one concentration test (100 mg/L) and one control group in a flow-through system. The test concentrations were measured at the start if the test, 48 h and 96 h using HPLC. Ten fish per group were exposed to the test item or the control for 96 h. The analysis of the test substance in the test solution was performed at the start (0h), before medium replacement (48h) and at the end of the test (96 h) by HPLC. Based on the resulted, the 96h-LC50 of choline chloride in Oryzias latipes was higher than 100 mg/L (nominal), based on mortality.

Description of key information

The available data refer to the degradation products of calcium phosphorylcholine chloride (choline and inorganic phosphate):

- Key study. Method according to OECD 203. GLP study. The 96h-LC50 of the substance choline chloride in Oryzias latipes was higher than 100 mg/L (nominal), based on mortality.

- Key study. Method according to OECD 203. GLP study. The 96h-LC50 of the substance calcium hydrogenorthophosphate in Oryzias latipes was above 100 mg/L (nominal) and the NOEC was 100 mg/L, both based on mortality.

Based on this information, it can be concluded that the substance phosphoryl choline chloride has a 96h-LC50 in Oryzias latipes above 100 mg/L.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
100 mg/L

Additional information

- Key study. A short-term toxicity test on fish was performed with choline chloride according to OECD Guideline 203 (1992 version), following GLP. A limit test was performed using one concentration test (100 mg/L) and one control group in a flow-through system. The test concentrations were measured at the start if the test, 48 h and 96 h using HPLC. Ten fish per group were exposed to the test item or the control for 96 h. The analysis of the test substance in the test solution was performed at the start (0h), before medium replacement (48h) and at the end of the test (96 h) by HPLC. Based on the resulted, the 96h-LC50 of choline chloride in Oryzias latipes was higher than 100 mg/L (nominal), based on mortality.

- Key study. A short-term toxicity test on fish was performed with calcium hydrogenorthophosphate according to OECD Guideline 203, under GLP conditions. In accordance with a range-finding preliminary study, a limit test was performed with Daphnia magna at 100 mg/L of test item and one control group in a static system. A stability test was performed during test at nominal concentrations of 10 and 100 mg/L. Seven fish per group were exposed to the test item or the control for 96 h. The analysis of the test solution was performed at 1, 24, 48, 72 and 96 h using inductively coupled plasma (ICP). Based on the results, the 96-h-LC50 of the test item in Oryzias latipes was above 100 mg/L (nominal) and the NOEC was 100 mg/L, both based on mortality.