Alkali salt of substituted alkyl amino sulfonyl triazinyl amino arylamido diazo aryl sulfonyl sulfonate

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:

from 2011-11-30 to 2012-03-20

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)

Version / remarks:

2004

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 850.1010 (Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids)

Version / remarks:

2012

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Version / remarks:

2008

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

Prior to treatment of each renewal periods, a test solution of 100 mg/L (nominal) was prepared by diluting an appropriate amount of test item in ISO medium. An amount of 50 mg test substance was diluted in 500 mL ISO medium and then distributed into test vessels.

Vehicle:

yes

Details on test solutions:

Dilution and Preparation of Testing Solutions: Prior to treatment of each renewal periods, a test solution of 100 mg/L (nominal) was prepared by diluting an appropriate amount of test item in ISO medium. An amount of 50 mg test substance was diluted in 500 mL ISO medium and then distributed into test vessels.

Untreated Control: The dilution water (ISO-medium) was used without of addition of the test item.

Reference Control: For the evaluation of the quality of the Daphnia clone and the experimental conditions, Potassium dichromate is tested at least twice a year to demonstrate satisfactory test conditions.
The date of the last study (Study Code: 11/168-023DA) with reference item Potassium dichromate (batch no.: 0769128) is: 12-14 July 2011.
The 24h EC50: 0.79 mg/L, (95 % confidence limits: 0.74 – 0.84 mg/L)

Test organisms (species):

Daphnia magna

Details on test organisms:

Species and strain: Daphnia magna
Source: National Institute of Public Health, 1097 Budapest Gyáli u. 2-6. Hungary
Breeding: The Daphnia are bred in Ecotoxicological Laboratory of CiToxLAB Hungary Ltd.
The health of the stock animals is continuously monitored by visual daily checking. Abnormal behaviour or significant decrease of population is recorded.
Justification of strain: Daphnia magna is the standard species of the acute immobilisation test.
Number of animals: There were 20 animals in test group and control group respectively, divided into 4 replicates (5 animals / replicate).
Age of the animals: They were less than 24 h old at the beginning of the test.
Acclimatization: There was no acclimatization because the water used was similar to the culture water.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Post exposure observation period:

No post exposure observation period

Hardness:

The reconstituted water (ISO medium) had an approximate theoretical total hardness of 249 mg/L (as CaCO3).

Test temperature:

The water temperature was measured at the start and at the end of each renewal period in each test vessel. The test temperature was in the range of 21.0 – 21.2 °C measured in the test vessels.
The additionally measured temperature in the climate chamber was between 20.8 and 21.3°C.

pH:

The pH of the test solution was not adjusted and not varied by more than 1.5 units in any one test. The pH was measured at the start and at the end of each renewal period in each test vessel and was in the range of 7.70 – 8.03.

Dissolved oxygen:

The dissolved oxygen concentration was measured in each test vessel at the start and at the end of each renewal period and was in the range of 7.1 – 7.3 mg/L.

Salinity:

Not specified

Nominal and measured concentrations:

Concentration of Reactive Yellow F01-0555 was analytically determined at the start and at the end of the experiment.
The measured concentration in the applied test concentration level was 103.4 mg/L at the start and 104.6 mg/L at the end of the test.

Details on test conditions:

The test duration was 48 hours. Twenty animals, divided into four groups (glass beaker) of five animals each (at least 4 mL test solution/animal) were used at the test concentration and for the control. The animals were not fed during the test.
The choice of the test concentration was done on the basis of the results of a preliminary range-finding test.

Preliminary Range Finding Test: A concentration range-finding test was conducted to determine the approximate toxicity of the test item so that appropriate test concentrations can be selected for use in the definitive test. Ten daphnids (divided into two replicates) in each test concentration and control were exposed for 48 hours.

Concentration Levels Investigated in the Main Test: Because toxic response was not observed during the preliminary concentration range-finding test, a limit test was carried out using only one test concentration (100 mg/L) and one control group.

Observations: The immobility or mortality of the Daphnia was determined by visual observation 24 and 48 hours after the start of the test. Those animals not able to swim within 15 seconds after gentle agitation of the test beaker are considered to be immobile.
The number of immobilised animals and the percentage of immobility were determined at 24 and 48 hours.
The water temperature, oxygen concentrations and pH of the controls and the test solution were measured at the beginning and at the end of the experiment.

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

LOEC

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC100

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

Validity: There were no immobilized animal in the control group and the dissolved oxygen concentration at the end of the test in control and test vessels was more than 3 mg/L. All validity criteria were within acceptable limits and therefore the study can be considered as valid.

Concentrations of the test item: Concentration of Reactive Yellow F01-0555 was analytically determined at the start and at the end of the experiment.
The measured concentration in the applied test concentration level was 103.4 mg/L at the start and 104.6 mg/L at the end of the test. As the measured concentration deviated not more than 20 per cent from the nominal value during the experiment, the biological results are based on the nominal concentration.

Immobilisation: The number of immobilised animals and the percentage of immobility were determined at the 24th and 48th hour.
There was no immobilisation in 20 daphnids exposed to each group. In addition to immobility, no abnormal behaviour or appearance of test animals was detected.

Results with reference substance (positive control):

The 24h EC50: 0.79 mg/L, (95 % confidence limits: 0.74 – 0.84 mg/L)
The date of the last study (Study Code: 11/168-023DA) with reference item Potassium dichromate (batch no.: 0769128) is: 12-14 July 2011.

Reported statistics and error estimates:

No statistical analysis was performed because of the lack of toxic effects.
The EC50, NOEC, LOEC and EC100 values were determined directly from the raw data.

Table 1: Immobilisation of the test animals

Test group	Number of animals	Number of immobilised animals
		24 h	48 h
Control	5	0	0
	5	0	0
	5	0	0
	5	0	0
100 mg/L (nominal)	5	0	0
	5	0	0
	5	0	0
	5	0	0

Validity criteria fulfilled:

yes

Conclusions:

Based on the results of this study, the test item Reactive Yellow F01-0555 had no toxic effect on daphnids at up to at least 100 mg/L nominal.

Executive summary:

This study has been performed in accordance with the study plan the OECD Guidelines for Testing of Chemicals (No. 202, 13 April 2004) and Directive 92/69/EEC, Annex Part C, C.2 and the EPA Health Effects Test Guidelines (OPPTS 850.1010) and the Principles of Good Laboratory Practice (GLP) Regulations. This study is reported with a valid GLP certificate.

 

Acute toxicity of Reactive Yellow F01-0555 on Daphnia magna was assessed in an Acute Immobilisation Test, over an exposure period of 48 hours in a static test system.

 

Toxic effects were not observed during the preliminary concentration range-finding test therefore a limit test was performed in the main experiment using only one test concentration (100 mg/L nominal) and one control group.

 

The test design included four replicates at each test group (test item and control). Each group comprised twenty Daphnia, five in each of the four replicate vessels, each containing approximately 40 mL test dilution.

 

There was no immobilisation in 20 daphnids exposed to each group. In addition, no abnormal behaviour or appearance of test animals was detected.

 

Test concentration was analytically determined at the start and at the end of the experiment. The measured concentration was 103.4 mg/L at the start and 104.6 mg/L at the end of the test. As the measured concentration deviated not more than 20 per cent from the nominal value during the experiment, the biological results are based on the nominal concentration.

 

All validity criteria were met during this study.

 

Based on the results of this study, the test item Reactive Yellow F01-055 had no toxic effect on daphnids at up to at least 100 mg/L nominal.

Description of key information

Based on the results of this study, the test item Reactive Yellow F01-0555 had no acutely toxic effect on daphnids at up to at least 100 mg/L nominal.