7,7'-(carbonyldiimino)bis[4-hydroxy-3-[(6-sulpho-2-naphthyl)azo]naphthalene-2-sulphonic] acid, sodium salt, compound with 2,2',2''-nitrilotriethanol

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:

2012-11-22 to 2012-11-24 (exposure period)

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study with analytical monitoring

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Sampling method: The samples of fresh water solution at the test initiation and the samples of spent water solution at test termination were analysed in order to determine the contents of the test substance in the test solution.
- Sample preparation for analysis: A water sample in a volume of 10 - 200 mL (i.e. control sample, test sample, sample fortified with the standard) was evaporated to dryness at 100°C using a vacuum rotary evaporator. The dry residue was redissolved in a suitable amount of water and analyzed spectrophotometrically.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: After thoroughly mixing 500.3 mg of the test item was filled up to 50.0 mL of Elendt Medium (M 7). After mixing by hand a homogeneous solution was obtained. The solution was mixing by hand thoroughly and used to prepare the test concentration 120 mg/L. 18 mL were pipetted into a volumetric flask with the Elendt Medium and filled up to 1500 mL.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Source: Standard Iabaratory culture maintained at the Institute of lndustrial Organic Chemistry, Branch Pszczyna, Department of Ecotoxicology, Labaratory of Aquatic Toxicology
- Age at study initiation: Up to 24 hours
- Method of breeding: Parthenogenetical reproduction
- Feeding during test: none
- Type and amount of food during culturing: The daphnids were fed with Pseudokirchneriella subcapitata algae suspension originating from the culture at the Labaratory of Aquatic Toxicology, Group B vitamins and micronutrients necessary for proper growth werr supplied with lyophilized Spirulin sp. suspension

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test temperature:

19.9 – 20.4°C

pH:

7.52 – 7.55 (control)

Dissolved oxygen:

8.6 – 9.6 mg/L

Nominal and measured concentrations:

Nominal concentration: 120 mg/L
Measured concentrations: At test initiation 98.20% of and at test termination 100.09% of the nominal concentration (mean values).

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass beakers of 150 mL capacity covered with transparent Iids in order to minimize evaporation and to prevent accidental contamination
- Fill volume: 100 mL
- Aeration: none
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 8
- No. of vessels per control (replicates): 8

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: According to guideline
- Intervals of water quality measurement: at test start and at test termination

OTHER TEST CONDITIONS
- Photoperiod: light: dark ratio of 16 h: 8 h

EFFECT PARAMETERS MEASURED: Mobility

TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 0.1; 1.0; 10.0 and 100.0 mg/L (nominal values)
- Results used to determine the conditions for the definitive study: yes

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

>= 120 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: Concentration analytically verified

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 120 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: Concentration analytically verified

Details on results:

- Mortality of control: none
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no
- Effect concentrations exceeding solubility of substance in test medium: no

Results with reference substance (positive control):

- Results with reference substance valid? Yes
- EC50/LC50: The EC50 (24 h) value was 1.77 mg/L and the EC50 (48 h) value was 0.61 mg/L

Validity criteria fulfilled:

yes

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 justification in section 13 of IUCLID.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Sampling method: The samples of fresh water solution at the test initiation and the samples of spent water solution at test termination were analysed in order to determine the contents of the test substance in the test solution.
- Sample preparation for analysis: A water sample in a volume of 10 - 200 mL (i.e. control sample, test sample, sample fortified with the standard) was evaporated to dryness at 100°C using a vacuum rotary evaporator. The dry residue was redissolved in a suitable amount of water and analyzed spectrophotometrically.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: After thoroughly mixing 500.3 mg of the test item was filled up to 50.0 mL of Elendt Medium (M 7). After mixing by hand a homogeneous solution was obtained. The solution was mixing by hand thoroughly and used to prepare the test concentration 120 mg/L. 18 mL were pipetted into a volumetric flask with the Elendt Medium and filled up to 1500 mL.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Source: Standard Iabaratory culture maintained at the Institute of lndustrial Organic Chemistry, Branch Pszczyna, Department of Ecotoxicology, Labaratory of Aquatic Toxicology
- Age at study initiation: Up to 24 hours
- Method of breeding: Parthenogenetical reproduction
- Feeding during test: none
- Type and amount of food during culturing: The daphnids were fed with Pseudokirchneriella subcapitata algae suspension originating from the culture at the Labaratory of Aquatic Toxicology, Group B vitamins and micronutrients necessary for proper growth werr supplied with lyophilized Spirulin sp. suspension

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test temperature:

19.9 – 20.4°C

pH:

7.52 – 7.55 (control)

Dissolved oxygen:

8.6 – 9.6 mg/L

Nominal and measured concentrations:

Nominal concentration: 120 mg/L
Measured concentrations: At test initiation 98.20% of and at test termination 100.09% of the nominal concentration (mean values).

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass beakers of 150 mL capacity covered with transparent Iids in order to minimize evaporation and to prevent accidental contamination
- Fill volume: 100 mL
- Aeration: none
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 8
- No. of vessels per control (replicates): 8

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: According to guideline
- Intervals of water quality measurement: at test start and at test termination

OTHER TEST CONDITIONS
- Photoperiod: light: dark ratio of 16 h: 8 h

EFFECT PARAMETERS MEASURED: Mobility

TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 0.1; 1.0; 10.0 and 100.0 mg/L (nominal values)
- Results used to determine the conditions for the definitive study: yes

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

>= 120 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: Concentration analytically verified

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 120 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: Concentration analytically verified

Details on results:

- Mortality of control: none
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no
- Effect concentrations exceeding solubility of substance in test medium: no

Results with reference substance (positive control):

- Results with reference substance valid? Yes
- EC50/LC50: The EC50 (24 h) value was 1.77 mg/L and the EC50 (48 h) value was 0.61 mg/L

Validity criteria fulfilled:

yes

Conclusions:

NOEC and EC50 >120 mg/L

Description of key information

With high probability acutely not harmful to aquatic invertebrates.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

120 mg/L

Additional information

The acute toxicity of the test substance on Daphnia magna was investigated in a GLP guideline study according to OECD 202. In this limit test, no toxic effects on the test organisms were observable at an analytically verified concentration of 120 mg/L (BASF SE 50E0861/11X413, 2012). Hence, the test substance is not considered to be acutely harmful to aquatic invertebrates.