Sodium [5-chloro-3-[[4,5-dihydro-3-methyl-5-oxo-1-(3-sulphophenyl)-1H-pyrazol-4-yl]azo]-2-hydroxybenzenesulphonato(4-)]chromate(1-)

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2015

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)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: BC3384Y14 (India)

Analytical monitoring:

yes

Details on sampling:

No data

Vehicle:

not specified

Details on test solutions:

M4 medium

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Source: RCC Ltd.
- Age at study initiation (mean and range, SD): Young daphnids, aged less than 24 hours old

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Post exposure observation period:

Not available

Hardness:

220 mg/L

Test temperature:

20.4 °C

pH:

7.59 - 7.70

Dissolved oxygen:

7.43 – 7.66 mg/L

Salinity:

Not available

Nominal and measured concentrations:

A range finding experiment was conducted to determine the range of concentrations for the main experiment. In range finding experiment, the daphnids were exposed to a series of widely spaced concentrations of the test item viz., 0.001, 0.01, 0.1, 1, 10, 50 and 100 mg/L.

Based on the results of the range finding experiment, seven test concentrations viz., 1, 1.5, 2.3, 3.4, 5.1, 7.6 and 11.4 mg/L were fixed in a geometric series with a separation factor of 1.5.

Details on test conditions:

TEST SYSTEM
- No. of organisms per vessel: 10 daphnids

Reference substance (positive control):

yes

Remarks:

Potassium Dichromate Pure

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

3.4 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

6.11 mg/L

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

LOEC

Effect conc.:

5.1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Details on results:

Based on the test results, the EC50 of FAT 20043/E in Daphnia magna observed for a period of 48 hours was calculated as 6.11 mg/L with upper confidence limits of 6.63 mg/L and lower confidence limits of 5.64 mg/L and regression equation Y = -1.3294 + 8.0509 log (x).
The no observed effect concentration (NOEC) was calculated as 3.4 mg/L and the low observed effect concentration (LOEC) was calculated as 5.1 mg/L.

Results with reference substance (positive control):

Based on the test results, the EC50 of Potassium Dichromate Pure in Daphnia magna observed for a period of ‘24’ hour was calculated as 1.72 mg/L with upper confidence limits of 2.12 mg/L and lower confident limits of 1.40 mg/L and regression equation Y = 4.0957 + 3.8604 log (x). At 48 hours, the EC50 was calculated as 1.33 mg/L with upper confidence limits of 1.63 mg/L and lower confidence limits of 1.08 mg/L and regression equation Y = 4.5239 + 3.8769 log (x).

Reported statistics and error estimates:

None

Validity criteria fulfilled:

yes

Conclusions:

Based on the test results, the EC50 of FAT 20043/E in Daphnia magna observed for a period of 48 hours was calculated as 6.11 mg/L with upper confidence limits of 6.63 mg/L and lower confidence limits of 5.64 mg/L and regression equation Y = -1.3294 + 8.0509 log (x). The no observed effect concentration (NOEC) was calculated as 3.4 mg/L and the low observed effect concentration (LOEC) was calculated as 5.1 mg/L.

Executive summary:

An acute immobilization toxicity study in Daphnia magna was conducted in accordance with OECD guideline 202 with FAT 20043/E. Test item was soluble and hence formulated in M4 medium. Based on the results of the range finding experiment, main experiment was conducted with a range of concentrations with 1, 1.5, 2.3, 3.4, 5.1, 7.6 and 11.4 mg/L. No immobilization was observed in control and daphnids exposed to 1, 1.5 and 2.3 mg/L test concentrations throughout the experimental period. At the end of 24 hour, no immobility was observed in daphnids exposed to any of the test concentrations. Thus, the percent immobilisation at the end of 24 hour was recorded to be 0 % in control and daphnids exposed to all the test concentrations. At the end of 48 hour, 2/40, 8/40, 31/40 and 40/40 immobility was recorded in the daphnids exposed to 3.4, 5.1, 7.6 and 11.4 mg/L concentration respectively. Thus the percent cumulative immobilisation at the end of 48 hour was recorded to be 0 % in control and daphnids exposed to 1, 1.5 and 2.3 mg/L test concentration whereas, 5 %, 20 %, 77.5 % and 100 % was observed in daphnids exposed to 3.4, 5.1, 7.6 and 11.4 mg/L concentrations, respectively. Based on the test results, the EC50 of FAT 20043/E in Daphnia magna observed for a period of 48 hour was calculated as 6.11 mg/L.The no observed effect concentration (NOEC) was calculated as 3.4 mg/L and the low observed effect concentration (LOEC) was calculated as 5.1 mg/L.

Description of key information

A GLP-compliant study was carried out in accordance with OECD Guidelines for the testing of chemicals, section 2 Number 202 “Daphnia Sp., Acute Immobilisation Test”, Adopted 13^thApril 2004 to assess the effect of FAT 20043/E.

Based on the results of a range finding experiment the test concentrations were set as follows: 1, 1.5, 2.3, 3.4, 5.1, 7.6 and 11.4 mg/L. Four replicates each containing 10 daphnids were held for each test concentration and a control group. Analysis of the test preparations at 0 and 48 hours showed measured concentrations to be near nominal and so the results are based on nominal concentrations only. Based on the test results, the EC50 of FAT 20043/E in Daphnia magna observed for a period of 48 hours was calculated as 6.11 mg/L.The no observed effect concentration (NOEC) was calculated as 3.4 mg/L and the low observed effect concentration (LOEC) was calculated as 5.1 mg/L.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

6.11 mg/L