3-[ethyl[4-[(4-nitrophenyl)azo]phenyl]amino]propiononitrile

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:

24 October 2017 to 26 October 2017

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

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Version / remarks:

Report states C.3; it is assumed that this is a typographical error

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: Guidelines for studies on the new chemical substance

Version / remarks:

Guidelines for studies on the new chemical substance as required by the Law Concerning the Evaluation of Chemical Substances and Regulation of their Manufacture, etc (Chemical Substance Control Law) 1973, amended 2009 under the reference of YAKUSHOKHATSU No. 1121002, SEIKYOKU No.2 and KANPOKIHATSU No. 021121002 and partially amended 2006 as the joint ordinance of The Japanese Ministry of Economy Trade and Industry (METI), Ministry of Health, Labour and Welfare (MHLW) and Ministry of the Environment (MOE).

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: JMAFF 2-7-2-1

Version / remarks:

JMAFF 2-7-2-1 The guidelines related to the study reports for the registration application of pesticide (Ref. No. 12-Nousan-8147 on 24 November 2000) & Ref. No.13-Seisan-3986 on 10 October 2001

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: because the test material was very poorly soluble in water, a test solution was prepared using a saturated solution method according to the Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures, OECD No. 23. A saturated test material solution (nominal loading rate of 100 mg/L) was prepared by dispersing/dissolving the amount of test material into the test medium (ISO Medium) two days before the start of the experiment. This solution was shaken for approximately 24 hours at approximately 30°C (Day -2) and then was equilibrated for approximately 24 hours at approximately 20°C (Day -1). The non-dissolved test materials were removed by filtration through a fine (0.22 μm) filter to give the 100% saturated solution. As only limit test was carried out, further dilution of this saturated solution was not performed. Test solution was distributed into test vessels prior to introduction of Daphnia.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Source: Szent István University, Department of Aquaculture 2100 Gödöllő, Páter Károly u. 1. – Hungary

ACCLIMATION
There was no acclimatisation because the water used was similar to the culture water.

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

247 mg/L (as CaCO3)

Test temperature:

20.1 - 20.6°C

pH:

7.06 - 7.54

Dissolved oxygen:

7.8 - 8.7 mg/L

Nominal and measured concentrations:

100% saturated solution (because a significant toxic response was not observed during the range-finding test)

Details on test conditions:

TEST SYSTEM
- Test vessel: glass beakers
- Material, size, headspace, fill volume: at least 5 mL test solution/animal
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted water (ISO medium, according to OECD 202) was used as dilution water for both the range finding and definitive tests. The same composition of reconstituted water was used for the tests and for breeding the test animals.
- Intervals of water quality measurement: The water temperature, the oxygen concentrations and pH of the controls and the test solution were measured at the beginning and at the end of the renewal periods.

OTHER TEST CONDITIONS
- Photoperiod: 16 hour light/8 hour darkness

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): immobility or mortality of 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 beaker were considered to be immobile. The number of immobilised animals and the percentage of immobility was determined at 24 and 48 hours.

VEHICLE CONTROL PERFORMED: no

RANGE-FINDING STUDY
- Test concentrations: 0, 0.1, 1, 10 and 100 % saturated solution
- Results used to determine the conditions for the definitive study: yes

Reference substance (positive control):

yes

Remarks:

For the evaluation of the quality of the Daphnia clone and validation of the experimental conditions, Potassium dichromate is tested at least twice a year to demonstrate satisfactory test conditions.

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 other: % saturated solution

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Key result

Duration:

48 h

Dose descriptor:

EC100

Effect conc.:

> 100 other: % saturated solution

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Key result

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

100 other: % saturated solution

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Key result

Duration:

48 h

Dose descriptor:

LOEC

Effect conc.:

> 100 other: % saturated solution

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

No animals were found to be immobile after 24 and 48 hours in both the control and test vessels.

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.

Validity criteria fulfilled:

yes

Conclusions:

Under the conditions of the study, the test material had no toxic effect at saturation; the EC50 result is higher than the solubility of the test material in the test medium.

Executive summary:

Acute toxicity of the test material on Daphnia magna was assessed in an acute immobilisation test, over an exposure period of 48 hours in a static test system. The study was conducted under GLP conditions and in accordance with the standardised guidelines OECD 202, EU Method C.2, US EPA OCSPP 850.1010 and JMAFF 2-7-2-1.

As toxic effects were not observed during the preliminary range-finding test, only one test concentration of 100% saturated solution (from a loading rate of 100 mg/L) and one control group was tested. The test was performed without analytical measurements because of the very poor water solubility of the test material. The test included twenty animals divided into four groups of five animals were used for the test concentration and the controls. 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. All validity criteria were met. The 48 h EC50, EC100, NOEC and LOEC are all 100% saturated solution.

Under the conditions of the study, the test material had no toxic effect at saturation; the EC50 result is higher than the solubility of the test material in the test medium.

Description of key information

Under the conditions of the study, the test material had no toxic effect at saturation; the EC50 result is higher than the solubility of the test material in the test medium.

Additional information

Acute toxicity of the test material on Daphnia magna was assessed in an acute immobilisation test, over an exposure period of 48 hours in a static test system. The study was conducted under GLP conditions and in accordance with the standardised guidelines OECD 202, EU Method C.2, US EPA OCSPP 850.1010 and JMAFF 2-7-2-1.

As toxic effects were not observed during the preliminary range-finding test, only one test concentration of 100% saturated solution (from a loading rate of 100 mg/L) and one control group was tested. The test was performed without analytical measurements because of the very poor water solubility of the test material. The test included twenty animals divided into four groups of five animals were used for the test concentration and the controls. 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. All validity criteria were met. The 48 h EC50, EC100, NOEC and LOEC are all 100% saturated solution.

Under the conditions of the study, the test material had no toxic effect at saturation; the EC50 result is higher than the solubility of the test material in the test medium.