Registration Dossier

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
Data is for read across substance
Justification for type of information:
Data for the target chemical is summarized based on the structurally similar read across chemicals.
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
other: As mention below
Principles of method if other than guideline:
WoE report is prepared based on short term toxicity to aquatic invertebrates studies
GLP compliance:
not specified
Analytical monitoring:
yes
Vehicle:
not specified
Details on test solutions:
WoE-2. Method: Test solutions were prepared by mixing a stock solution of the test substance, which was prepared by mixing and stirring the test substance and water.
Test organisms (species):
Daphnia magna
Details on test organisms:
WoE-2. Details on test organisms
TEST ORGANISM
- Common name: Water flea
- Feeding during test: No

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
WoE-2. 16 dH
Test temperature:
WoE-2. 20 ° C
Nominal and measured concentrations:
WoE-2. 350, 230, 160, 104, 69 mg/L (geometric ratio 1.5), control

WoE-3. control, 41, 75, 134, 241, 435, 782 mg/L (geometric ratio 1.8)
Details on test conditions:
WoE-2. Details on test conditions
TEST SYSTEM
- Type (delete if not applicable): closed (with gas phase)
- Material, size, headspace, fill volume: Test solution volume 400 mL/ concentration (100 mL/vessel)
- Aeration: No
- No. of organisms per vessel: 20 concentration (5 /vessel)
- No. of vessels per concentration (replicates): 4 /concentration
- No. of vessels per control (replicates): 4 /concentration,

WATER PARAMETERS: - Source/preparation of dilution water: dechlorinated tap water

OTHER TEST CONDITIONS: - Photoperiod: room light, 16 hours light hours dark


WoE-3.
TEST SYSTEM: -: test solution volume 100 mL,
- No. of organisms per vessel: 20 per concentration (5 per vessel),
- No. of vessels per concentration (replicates): 4,
OTHER TEST CONDITIONS: - Photoperiod: room light, 16 hours light / 8 hours dark
Reference substance (positive control):
not specified
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
200 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: 95 % CL: 180 - 230 mg/L
Remarks:
1st study
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
224 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: 95 % CL: 134 mg/L - 435 mg/L
Duration:
48 h
Dose descriptor:
EC100
Effect conc.:
435 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
134 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Validity criteria fulfilled:
not specified
Conclusions:
The EC 50 value of test chemical is expected to be range from 200 -224 mg/l. By considering this range EC 50 value test chemical is considered to be non toxic and not classified as per the CLP classification criteria. 
Executive summary:

Short term toxicity of test chemical on the growth of aquatic invertebrates was determined on the basis of data of structurally and functionally similar read across chemicals. The studies are as mentioned below:

 

The first study was reviewed from authoritative database in this the effect of test chemical on Daphnia magna was determined for the exposure period of 48 hrs. Test conducted according to OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test). Test solutions were prepared by mixing a stock solution of the test substance, which was prepared by mixing and stirring the test substance and water.Test performed at different concentrations 350, 230, 160, 104, 69 mg/L (geometric ratio 1.5), control. Test vessel filled with 400 mL/ concentration (100 mL/vessel) contain 20 daphnia per concentration (5 / vessel). Experiment repeated 4 times with the same condition. Analytical monitoring was done using the GC was the Frequency of analysis was at the start of exposure and the end of exposure. Based on the immobility of test organism daphnia magna due to the exposure of test chemical for 48 hrs, the median effect concentration was determined to be 200 mg/l. Thus on the basis of EC50, chemical was consider as nontoxic and not classified as toxic as per the CLP classification criteria

 

Another study was also reviewed from the authoritative database in this the experiment was conducted according to OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test). Test performed at different concentrations of test chemical, 41, 75, 134, 241, 435, 782 mg/L (geometric ratio 1.8) and control. In this study the test solution volume used was 100 mL and the number of organisms per vessel was 20 per concentration (5 per vessel) and number of vessels per concentration (replicates) was four.

Based on the immobility of test organism daphnia magna due to the exposure of test chemical for 48 hrs, the effect concentration (EC 50 ) value, EC100 value and NOEC value was determined to be 224 mg/L, 435 mg/L 134 mg/L respectively. Thus on the basis of EC50, chemical was consider as nontoxic and not classified as toxic as per the CLP classification criteria.

 

Thus based on the results of both the studies for test chemical, it can be concluded that  EC 50 value of test chemical is expected to be in range from 200 -224 mg/l. By considering this range EC 50 value test chemical is considered to be non toxic and not classified as per the CLP classification criteria. 

Description of key information

The EC 50 value of test chemical is expected to be range from 200 -224 mg/l. By considering this range EC 50 value test chemical is considered to be non toxic and not classified as per the CLP classification criteria. 

Key value for chemical safety assessment

EC50/LC50 for freshwater invertebrates:
200 mg/L

Additional information

Short term toxicity of test chemical on the growth of aquatic invertebrates was determined on the basis of data of structurally and functionally similar read across chemicals. The studies are as mentioned below:

 

The first study was reviewed from authoritative database in this the effect of test chemical on Daphnia magna was determined for the exposure period of 48 hrs. Test conducted according to OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test). Test solutions were prepared by mixing a stock solution of the test substance, which was prepared by mixing and stirring the test substance and water.Test performed at different concentrations 350, 230, 160, 104, 69 mg/L (geometric ratio 1.5), control. Test vessel filled with 400 mL/ concentration (100 mL/vessel) contain 20 daphnia per concentration (5 / vessel). Experiment repeated 4 times with the same condition. Analytical monitoring was done using the GC was the Frequency of analysis was at the start of exposure and the end of exposure

Based on the immobility of test organism daphnia magna due to the exposure of test chemical for 48 hrs, the effect concentration was determined to be 200 mg/l. Thus on the basis of EC50, chemical was consider as nontoxic and not classified as toxic as per the CLP classification criteria

 

 Another study was also reviewed from the authoritative database in this the experiment was conducted according to OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test). Test performed at different concentrations of test chemical, 41, 75, 134, 241, 435, 782 mg/L (geometric ratio 1.8) and control. In this study the test solution volume used was 100 mL and the number of organisms per vessel was 20 per concentration (5 per vessel) and number of vessels per concentration (replicates) was four.

Based on the immobility of test organism daphnia magna due to the exposure of test chemical for 48 hrs, the effect concentration (EC 50 ) value, EC100 value and NOEC value was determined to be 224 mg/L, 435 mg/L 134 mg/L respectively. Thus on the basis of EC50, chemical was consider as nontoxic and not classified as toxic as per the CLP classification criteria.

 

Thus based on the results of both the studies for test chemical, it can be concluded that  EC 50 value of test chemical is expected to be in range from 200 -224 mg/l. By considering this range EC 50 value test chemical is considered to be non toxic and not classified as per the CLP classification criteria.