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Short-term toxicity to aquatic invertebrates

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Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
17 August 2016 to 31 August 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reason / purpose for cross-reference:
other: read-across target
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Version / remarks:
13 April 2004
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
Test concentration analysis was done at Auriga Research Ltd, Unit-III, No. 136, 6th Cross, 2nd Stage, Yeshwanthpur industrial suburb, Bangalore-560022.
During range finding study and main study, samples from all the test concentrations was collected at 0 hour on day 0 for the analysis of test concentration and at 48 hour on day 2 for stability analysis. The samples were collected from the central point of the test vessel. The validated analytical method for determination of test concentrations analysis of DOTE was used for analytics.
The test concentration samples were collected in duplicates (2 x 10 mL) for each test concentration including vehicle control and transferred at ambient condition for test concentration confirmation analysis to Auriga Research Ltd, Unit-III, No. 136, 6th Cross, 2nd Stage, Yeshwanthpur industrial suburb, Bangalore-560022. Results are based on measured concentration, the concentration of test material was satisfactorily maintained within 20 percent of nominal concentration.
Vehicle:
yes
Details on test solutions:
Based on the in house dissolution test, the test material was miscible in DMSO (100 µL/L) and reconstituted water. Hence DMSO (100µL/L) and reconstituted water were selected as the vehicle for preparation of test material formulation.
Test organisms (species):
Daphnia magna
Details on test organisms:
In house maintained Daphnia magna procured, from Environmental and Molecular Toxicology Division, Department of Zoology, Karnataka University, Karnataka, India.
Young daphnids less than 24 h old. (Derived from healthy stock showing no signs of stress, such as high mortality rate, discolored daphnids, presence of male and ephippia, delay in the production of the first brood).
Test type:
static
Water media type:
freshwater
Total exposure duration:
48 h
Hardness:
216 - 220 mg CaCO3/L
Test temperature:
20.2 - 20.3 °C
pH:
6.29 - 3.8
Dissolved oxygen:
At the end of the test
7.16 mg/L in control
7.10 mg/L in test vessels
Nominal and measured concentrations:
Range Finding Study
A range finding (RF) study with 6 concentrations of 0.01, 0.1, 1.0, 10.0, 50.0 and 100.0 mg/L of test material was used along with controls (negative and solvent) to find out the range of the lethal concentrations.

Main Study
Based on results of the range finding study, the main study was conducted at the scattered concentrations of 0.05, 0.1, 1.0, 5.0, 20.0 and 40 mg/L specified by the sponsor (rationale of concentration spaced is not as per geometric factor specified in guideline, OECD 203 Daphnia sp., Acute Immobilization Test) along with the control groups (negative and solvent groups).
Reference substance (positive control):
yes
Remarks:
Potassium dichromate
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
24.12 mg/L
Basis for effect:
mobility
Results with reference substance (positive control):
The 48 hour acute median effective concentration (EC50) of potassium dichromate on Daphnia was 0.90 mg/L [RC1] (BIO-ET 051). This 48 hour EC50 of potassium dichromate lies in the validity criteria acceptance range (0.60 to 2.12 mg/L) towards test system response and test procedure followed. Hence this test with reference standard establishes the acceptability of test system response and test procedure followed.
Validity criteria fulfilled:
yes
Conclusions:
Based on the results of the experiment and under the experimental conditions employed, it can be concluded that the 48 hour acute median effective concentration (EC50) of the test material on Daphnia is 24.12 mg/L.
Executive summary:

The toxicity of the test material to the aquatic invertebrate, Daphnia magna, was investigated in a study which was conducted in accordance with the standardised guideline OECD 202, under GLP conditions.

During the study, daphnids were exposed to the test material under static conditions. Daphnids were observed at 24 and 48 hours for signs of toxicity and immobility. For the range finding study duplicate containers of 5 daphnids at each concentration plus control groups (negative and solvent) were used. Daphnids were exposed to test concentrations of 0.01, 0.1, 1.0, 10.0, 50.0 and 100.0 mg/L of test material. Cumulative immobility of 10.0, 10.0, 20.0, 40.0 and 100.0 %, respectively, was observed within the test material groups. There were recorded observations of daphnids localised on the bottom of the container at the tested concentration of 1.0 mg/L. Lethargy in addition to daphnids localised on the bottom of container were observed at the test material concentrations of 10.0, 50.0 and 100.0 mg/L. No clinical signs or immobility were observed in negative or solvent controls during the 48 hour exposure period. Based on the results of the range finding study, the main study was conducted at concentrations of 0.05, 0.1, 1.0, 5.0, 20.0 and 40.0 mg/L. During the main study, quadruplicate containers of 5 daphnids were included at each concentration plus negative and solvent controls.

Cumulative immobility of 0.0, 10.0, 15.0, 30.0, 55.0 and 100.0% was observed at test material concentrations of 0.05, 0.1, 1.0, 5.0, 20.0 and 40.0 mg/L, respectively. No clinical signs or immobility were observed in negative or solvent controls during the 48 hour exposure period. Daphnids were observed to be localised on the bottom of container at the tested concentration of 0.1 mg/L. Lethargy was observed in addition to daphnids localised on the bottom of container at the tested concentrations of 1.0, 5.0, 20.0 and 40.0 mg/L. No clinical signs or immobility were observed in negative or solvent controls or at the test material concentration of 0.05 mg/L during the 48 hour exposure period. 

The test concentrations at the 0 hour were analytically confirmed to be within in the acceptable range of ± 20% recovey to the nominal concentrations.

Based on the above results of the experiment and under the experimental conditions employed, it can be concluded that the 48 hour acute median effective concentration (EC50) of the test material on Daphnia was determined to be 24.12 mg/L.

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted on read-across material
Justification for type of information:
Read-across from Dioctyltin bis (2-ethylhexylmercaptoacetate) (DOTE) (CAS No. 15571-58-1), see attached justification.
Reason / purpose for cross-reference:
read-across source
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
24.12 mg/L
Basis for effect:
mobility

Description of key information

Read-across from Dioctyltin bis (2-ethylhexylmercaptoacetate) (DOTE) (CAS No. 15571-58-1)

Based on the results of the experiment and under the experimental conditions employed, it can be concluded that the 48 hour acute median effective concentration (EC50) of the test material on Daphnia was determined to be 24.12 mg/L.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
24.12 mg/L

Additional information

Read-across from Dioctyltin bis (2-ethylhexylmercaptoacetate) (DOTE) (CAS No. 15571-58-1)

The toxicity of the test material to the aquatic invertebrate, Daphnia magna, was investigated in a study which was conducted in accordance with the standardised guideline OECD 202, under GLP conditions. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).

During the study, daphnids were exposed to the test material under static conditions.Daphnidswere observed at 24 and48 hoursforsigns of toxicity and immobility.For the range finding study duplicate containers of 5 daphnids at each concentration plus control groups (negative and solvent) were used. Daphnids were exposed to test concentrations of 0.01, 0.1, 1.0, 10.0, 50.0 and 100.0 mg/L of test material. Cumulative immobility of 10.0, 10.0, 20.0, 40.0 and 100.0 %, respectively, was observed within the test material groups. There were recorded observations of daphnids localised on the bottom of the container at the tested concentration of 1.0 mg/L. Lethargy in addition to daphnids localised on the bottom of container were observed at the test material concentrations of 10.0, 50.0 and 100.0 mg/L. No clinical signs or immobility were observed in negative or solvent controls during the 48 hour exposure period.Based on the results of the range finding study, the main study was conducted at concentrations of 0.05, 0.1, 1.0, 5.0, 20.0 and 40.0 mg/L. During the main study, quadruplicate containers of 5 daphnids were included at each concentration plus negative and solvent controls.

Cumulative immobility of 0.0, 10.0, 15.0, 30.0, 55.0 and 100.0% was observed at test material concentrations of 0.05, 0.1, 1.0, 5.0, 20.0 and 40.0 mg/L, respectively. No clinical signs or immobility were observed in negative or solvent controls during the 48 hour exposure period.Daphnids were observed to be localised on the bottom of container at the tested concentration of 0.1 mg/L. Lethargy was observed in addition to daphnids localised on the bottom of container at the tested concentrations of 1.0, 5.0, 20.0 and 40.0 mg/L. No clinical signs or immobility were observed in negative or solvent controls or at the test material concentration of 0.05 mg/L during the 48 hour exposure period. 

The test concentrations at the 0 hour were analytically confirmed to be within in the acceptable range of ± 20% recovey to the nominal concentrations.

Based on the results of the experiment and under the experimental conditions employed, it can be concluded that the 48 hour acute median effective concentration (EC50) of the test material on Daphnia was determined to be 24.12 mg/L.