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Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

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 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes (incl. QA statement)

Details on sampling:

40 mL of test samples from each group was drawn at 0 and 24 h. The representative samples were divided into two equal portions (20 mL). One portion (20 mL) was sent for test concentration analysis at Department of Chemistry and the second portion (20 mL) was stored at -20 ± 5 ºC temperature till the study completion. Active ingredient concentration in water was determined
using the validated analytical method.

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 RO 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, RO water was selected as the vehicle for study.

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

Healthy rainbow Trout, Oncorhynchus mykiss were originally procured from Government of Himachal Pradesh, O/O Deputy Director of Fisheries, Indo- Norwegian Trout Farming Project, Patlikuhal, Katrain, Distt. Kullu, Himachal Pradesh- 175129 and maintained at Section –
Ecotoxicology, Jai Research Foundation were used for study.

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

78.4 mg/L as CaCO3

Test temperature:

15.3-16.6ºC

pH:

7.11-7.53

Dissolved oxygen:

87.8 and 89.3%

Nominal and measured concentrations:

 0.0 (control), 1.0, 2.2, 4.8, 10.6, and 23.4 mg POLIOL MB 600/L for a period of 96 h. 

Details on test conditions:

Test Procedure : Semi-static toxicity test - test solutions were changed at every 24 h with freshly prepared solutions. At each renewal 100% of volume of the tank was renewed. During renewal, fish were transferred by netting to new test vessels. The test solutions were not aerated during the exposure.

Loading : A maximum loading of 1.0 g fish per liter of water was used. The volume of water used was 50 liters in a glass aquarium of 80 liters capacity for control and treated groups.

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

ca. 8.4 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.:

ca. 2.2 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

LOEC

Effect conc.:

ca. 4.8 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Reported statistics and error estimates:

The 96 h LC50 with 95% confidence interval was calculated following the Probit analysis method (Finney, 1971) using in-house developed validated software. NOEC and LOEC were determined and reported.

Validity criteria fulfilled:

yes

Conclusions:

96 h LC50 : 8.4 mg POLIOL MB 600/L
NOEC : 2.2 mg POLIOL MB 600/L
LOEC : 4.8 mg POLIOL MB 600/L

Executive summary:

EXECUTIVE SUMMARY: This study was performed to assess the acute toxicity on Rainbow Trout, 

Oncorhynchus mykiss, under semi-static conditions, caused by the exposure to POLIOL MB 600. 

Based on results of the preliminary range finding study, sixty fish were divided into six groups of ten fish. 

Fish were exposed using semi-static test method with renewal at every 24 h at 0.0 (control), 1.0, 2.2, 4.8, 

10.6, and 23.4 mg POLIOL MB 600/L for a period of 96 h. 

 

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

228-2-13-21963)  and  POLIOL  MB  600  in  test  media  was  stable  up  to  24  h  (>  80%  of  nominal 

concentration). Test media was analysed for POLIOL MB 600 active ingredient concentration to monitor 

the concentration and stability of test solution at 0 and 24 h of first renewal during main study. The active 

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

concentration).  

The maximum concentration of POLIOL MB 600, causing no mortality and the lowest concentration tested 

causing 100 percent mortality within the 96 h test period were 2.2 and 23.4 mg/L, respectively. The No 

Observed Effect Concentration (NOEC) and the Lowest Observed Effect Concentration (LOEC) over the 

96 h exposure period of POLIOL MB 600 was 2.2 and 4.8 mg/L, respectively. 

The 96 h LC50 of POLIOL MB 600 was determined as 8.4 mg/L. 

Reference 2

Endpoint:

short-term toxicity to fish

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:

96 h

Dose descriptor:

LOEC

Effect conc.:

ca. 4.8 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: Results of the source substance

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

ca. 2.2 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: Results of the source substance

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

ca. 8.4 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: Results for the source substance

Validity criteria fulfilled:

yes

Conclusions:

The maximum concentration of the substance, causing no mortality and the lowest concentration tested causing 100 percent mortality within the 96 h test period were 2.2 and 23.4 mg/L, respectively. The No Observed Effect Concentration (NOEC) and the Lowest Observed Effect Concentration (LOEC) over the 96 h exposure period of the substance was 2.2 and 4.8 mg/L, respectively. 

The 96 h LC50 for the substance was determined as 8.4 mg/L. 

Description of key information

LC50 for freshwater fish 8.4 mg/L

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

LC50

Effect concentration:

8.4 mg/L