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Ecotoxicological information

Short-term toxicity to aquatic invertebrates

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Administrative data

Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods
Qualifier:
according to guideline
Guideline:
other: Testing method relating to the new chemical substances, etc. (Yakushokuhatsu No. 1121002, Heisei 15-11-13 Seikyoku No. 2, Kanpokihatsu No. 031121002 on November 21, 2003).
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
Principles of method if other than guideline:
To assess the toxicity of the test substance by conducting acute swimming immobilization test in Daphnia magna for notification of the new chemical substance under the Chemical Substance Control Law (CSCL) in Japan.
GLP compliance:
yes
Specific details on test material used for the study:
During the study period, the test substance was stored in the desiccators for storage of the test substance in Yokohama Research Center (storage conditions: room temperature, under nitrogen purging).
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 4, 6, 8.9, 13, 20 mg/L
- Sampling method: The middle layer of the test solution was collected from the vessels for measurement of the test environment of each test concentration group at the start of exposure and after renewal of test solution, from one vessel of each test concentration group before renewal of the test solution and at the end of exposure.
- Sample storage conditions before analysis: Samples not stored analysis straightaway
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Eluate: Elendt M4 medium
- Controls: test water
- Concentration of vehicle in test medium (stock solution and final test solution(s) or suspension(s) including control(s)): none
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): None
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia
- Source: The Environment Agency, National Institute for Environmental Studies, Japan (subcultured at Yokohama Research Center)
- Age of parental stock (mean and range, SD): Female juveniles (<24h old)
- Feeding during test: None

Rearing conditions of parent Daphnia to obtain the test organisms:
The young daphnids derived from parent animals held under the following conditions were used for the test.
- Acclimation conditions (same as test or not): same as test
- Type and amount of food: Chlorella vulgaris (single-cell green algae) 6 mg C (organic carbon content)/2 L/day
- Feeding frequency: daily
- Health during acclimation (any mortality observed): none
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
236 CaCO3/L
Test temperature:
20 +/- 1°C
pH:
6.0 - 9.0
Dissolved oxygen:
3 mg/L and above, without aeration
Salinity:
Not applicable
Conductivity:
Not applicable
Nominal and measured concentrations:
Nominal: 4, 6, 8.9, 13 and 20 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: Beaker
- Type (delete if not applicable): open / closed: closed covered with teflon sheet and lid to prevent evaporation
- Material, size, headspace, fill volume: Glass, 100 mL, no headspace filled to top of vessel
- Aeration: no
- Renewal rate of test solution (frequency/flow rate): test solutions renewed after 24 hours
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
Elendt M4 medium (formulated water prescribed in OECD Guideline for Testing of Chemicals 202 (2004) Daphnia sp., Acute Immobilisation Test ) was sufficiently aerated and used for the test at the adjusted temperature of 20 ± 1°C. Theoretical hardness was 250 mg CaCO3/L. The hardness and pH of the test solution were measured before the start of exposure and they were 236 mg CaCO3/L and 8.4, respectively, and it was confirmed that these values were within the appropriate range (hardness: 250 mg CaCO3/L or below, pH: 6.0 to 9.0).

OTHER TEST CONDITIONS
- Adjustment of pH: none
- Photoperiod: Room light, 16 hours light , 8 hours dark
- Light intensity: 800 lux or less

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Frequency: At 24 hours (before the renewal of the test solution) and 48 hours after the start of exposure
Parameter: Number of immobilized test organisms*1, presence/absence of other abnormality*2

*1: Daphnia that could not swim for 15 seconds after gentle agitation of the test vessel were considered to be immobilized.
*2: Abnormal symptom in the activity or appearance (discoloration, etc.,) and daphnia floating on the water surface were recorded.

RANGE-FINDING STUDY
- Test concentrations: 0 (control), 2, 4, 20 and 32 mg/L
- Results used to determine the conditions for the definitive study: yes
Reference substance (positive control):
yes
Remarks:
potassium dichromate
Duration:
48 h
Dose descriptor:
EC0
Effect conc.:
3.44 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks:
none
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
6.48 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: 95% CL
Remarks:
5.87-7.09 mg/L
Duration:
48 h
Dose descriptor:
EC100
Effect conc.:
11.1 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Results with reference substance (positive control):
- Results with reference substance valid? yes
- Relevant effect levels: EC50 0.76 mg/L
- performed every 6 month to test sensitivity of Daphnia
Reported statistics and error estimates:
Probit analysis

Table 1 Measured concentrations of the test substance in test water

 Test group  Nominal Concentration              Measured Concentrations (mg/L)
   

 0 Hour

New

24 Hours

Old 

24 Hours

New 

48 Hours

Old 

Mean (TWA) 
                 (Percent of nominal, %)
 Control  -  <0.005 <0.005  <0.005  <0.005 
 1  4.0

 3.51

(88)

3.53

(88) 

3.43

(86) 

3.31

(83) 

3.44

(86) 

 2  6.0

5.01

(84) 

4.92

(82) 

5.04

(84) 

4.98

(83) 

4.99 

(83)

 3  8.9

7.55

(85) 

 7.38

(83)

7.94

(89) 

7.68

(86) 

7.64

(86) 

 4  13.0

11.3

(87) 

10.7

(82) 

11.3

(87) 

11.2

(86) 

11.1

(85) 

 5  20

 18.2

(91)

17.1

(86) 

17.7

(89) 

17.5

(88) 

17.6

(88) 

Table 2: no. of immobilized Daphnia magna (% immobility)

 Test group

 Nominal Concentration

(mg/L)

Mean Measured Concentration

(mg/L) 

    Cumulative no. of immobilized Daphnia

(% Immobility)

       24 hours  48 hours
 Control - 0 (0)  0(0) 
 1 4.0  3.44  0 (0) 0 (0) 
 2 6.0  4.99  0 (0)  1 (5) 
 3 8.9  7.64  0 (0)  17 (85) 
 4 13  11.1  0 (0)  20 (100) 
 5 20  17.6  20 (100)  20 (100) 
Validity criteria fulfilled:
yes
Conclusions:
The substance is toxic to aquatic invertebrates with a 48h EC50 value of 6.48 mg/L.

Description of key information

In an GLP-compliant study conducted with analytical monitoring in accordance with a standard method equivalent to the OECD guideline, the toxicity of the test item to aquatic invertebrates (Daphnia magna) was assessed. The 48h EC50 value was determined to be 6.48 mg/L indicating that the substance is toxic to aquatic invertebrates. The 48h EC50 value is used for the Chemical Safety Assessment.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
6.48 mg/L

Additional information