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Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February to April 2019

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

GLP compliance:

yes (incl. QA statement)

Vehicle:

yes

Details on test solutions:

Before conducting the preliminary range finding study, test item was checked for solubility and precipitation. First, an amount of 100 mg test item was diluted in 10 mL of reconstituted water but test item was not soluble completely. Gradually volume of test medium increased up to 200 mL along with sonication and found soluble (milky white solution) at the concentration of 0.5 mg/mL (stock A). Hence, reconstituted water was selected as the vehicle for study.

Test organisms (species):

Daphnia magna

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

201.6 mg/L as CaCO3

Test temperature:

20ºC

pH:

7.02-7.71

Dissolved oxygen:

8.09-8.62 mg/L

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Key result

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

ca. 1.5 mg/L

Conc. based on:

test mat.

Basis for effect:

mobility

Key result

Duration:

48 h

Dose descriptor:

LOEC

Effect conc.:

ca. 3.3 mg/L

Conc. based on:

test mat.

Basis for effect:

mobility

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

ca. 11.9 mg/L

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

Percent immobilisation observed at 24 h was 0, 0, 0, 10, and 25 at 1.5, 3.3, 7.2, 15.9, and 35.0
mg/L, respectively. No immobility was observed in any replicate of the control group.

Percent immobilisation observed at 48 h was 0, 5, 25, 65, and 100 at 1.5, 3.3, 7.2, 15.9, and 35.0 mg/L, respectively. No immobility was observed in any replicate of the control group.

At 24 h, lethargy was observed in, G6 (35.0 mg/L). No behavioural symptom was observed in G5
(15.9 mg/L). No immobility or behavioural symptom was observed in G4 (7.2 mg/L), G3 (3.3
mg/L), G2 (1.5 mg/L), and G1 (control) groups.

At 48 h, lethargy was observed in G5 (15.9 mg/L), and G4 (7.2 mg/L). All daphnids were found
immobiled at G6 (35.0 mg/L). No behavioural symptom was observed in G3 (3.3 mg/L). No
immobility or behavioural symptom was observed in G2 (1.5 mg/L) and G1 (control) groups

No sign of disease or stress (discolouration or unusual behaviour, such as trapping at the surface of
water) was observed in any replicate of the control group.

Validity criteria fulfilled:

yes

Conclusions:

Based on the result, it can be concluded that POLIOL MB 600 has some toxic effect on daphnids at the concentrations of 3.3, 7.2, 15.9, and 35.0 mg POLIOL MB 600/L, while POLIOL MB 600 has no effect on daphnids at the concentration 1.5 mg POLIOL MB 600/L. No Observed Effect Concentration (NOEC) was 1.5 mg/L and the Lowest Observed Effect Concentration (LOEC) was 3.3 mg/L over the 48 h exposure period of the POLIOL MB 600. The 48 h EC50 of the POLIOL MB 600 was determined 11.9 mg/L.

Executive summary:

This study was performed to assess toxic effects, on Daphnia magna, caused 

by exposure, under static conditions, to POLIOL MB 600. 

Based on results of the preliminary range finding study, concentration levels selected for the main study 

were 1.5, 3.3, 7.2, 15.9, and 35.0 mg POLIOL MB 600/L along with control. In the main study, 48 h static 

toxicity test procedure was followed, comprising seven groups along with control. Each group consisted of 

four replicates with 5 daphnids per replicate. 

The stability of POLIOL MB 600 in test media was performed during method validation (JRF Study N° 

228-2-13-21963). Test media was analysed for POLIOL MB 600 active ingredient concentration and 

stability to monitor the concentration level of test solution at 0 and 48 h, during the main study. The active 

ingredient concentration of POLIOL MB 600 in test media was within acceptable limit (>80% of nominal 

concentration). 

The highest tested concentration level of the POLIOL MB 600 causing no immobilisation and the No 

Observed Effect Concentration (NOEC) was 1.5 mg/L and the lowest tested concentration level causing 

100%  immobilisation  within  the  48  h  test  period  was  35.0  mg/L.  The  Lowest  Observed  Effect 

Concentration (LOEC) was 3.3 mg/L over the 48 h exposure period of the POLIOL MB 600. 

The 48 h EC50 of the POLIOL MB 600 was determined 11.9 mg/L. 

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

Read across from structural analogue, justification can be found attached in section 13.2.

Reason / purpose for cross-reference:

read-across source

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

ca. 11.9 mg/L

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: Results from the source substance

Key result

Duration:

48 h

Dose descriptor:

LOEC

Effect conc.:

ca. 1.5 mg/L

Conc. based on:

test mat.

Basis for effect:

mobility

Key result

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

ca. 1.5 mg/L

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: Results from fource substance

Validity criteria fulfilled:

yes

Conclusions:

Conclusions
Based on the result of the source substance, it can be concluded that the target substance has some toxic effect on daphnids at the concentrations of 3.3, 7.2, 15.9, and 35.0 mg /L, while has no effect on daphnids at the concentration 1.5 mg POLIOL MB 600/L.
No Observed Effect Concentration (NOEC) was 1.5 mg/L and the Lowest Observed Effect Concentration (LOEC) was 3.3 mg/L over the 48 h exposure period of the substance.
The 48 h EC50 of the POLIOL MB 600 was determined 11.9 mg/L.

Description of key information

EC50 for freshwater invertebrates 11.9 mg/L

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Dose descriptor:

EC50

Effect concentration:

11.9 mg/L