7-amino-4-hydroxy-3-[[4-[(4-sulphophenyl)azo]phenyl]azo]naphthalene-2-sulphonic acid, compound with 2,2',2''-nitrilotriethanol (1:2)

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:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

1984

Qualifier:

according to guideline

Guideline:

other: Real Decreto 363/1995 (BOE núm. 133 de Junio de 1995)

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

yes

Details on test solutions:

Taking into account the value of 27.4% of active ingredient, the study will be carried out with the 100% active ingredient of the presented material.
Preparation of the 3.65 g / L of the test material: 0.365 g of the test material has been dissolved in 100 mL of culture medium in a volumetric flask, Class A of 100 mL by means of agitation and a stock solution of 3650 mg / L has been obtained. The test material has a content of 27.4 % active material, thus the stock solution contains 1000 mg / L of active material. The different solutions used in the test have been prepared from this stock solution of 1000 mg / L.
Actual concentration of the stock solution: 1005.7 mg/L of active ingredient.

Test organisms (species):

Daphnia magna

Details on test organisms:

Strain: Daphnia magna, Strauss (Cladocera, Crustacea)
Age: ≤ 24-hours life, in good physiological conditions
Origin: Stirling University, United Kingdom

Culture conditions: The cultivation of daphnia from which the Individuals to carry out the test has been done with the following conditions:
- Temperature: between 18 and 22 ºC
- Photoperiod of 16 hours of light / 8 hours of darkness
- No aeration
- Feeding: Type of food: Chlorella (freshwater microalgae) and marine algae extract
- Frequency of feeding: 3 times / week

Test type:

not specified

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test temperature:

20 ± 2 ºC

pH:

Average pH value of culture at the beginning of the test: 7.65
pH value of culture medium at the end of the test: 7.37
pH Minimum concentration at the start of the test: 7.83
pH Minimum concentration at the end of the test: 7.38
pH value maximum concentration at start of test: 7.53
pH value maximum concentration at the end of the test: 7.32

Dissolved oxygen:

Dissolved O2 concentration values (mg / L):
Dissolved O2 value culture medium at the beginning of the test: 8.48
Dissolved O2 value culture medium at the end of the test: 8.36
Dissolved O2 value minimum concentration at start of test: 8.45
Dissolved O2 value minimum concentration at end of test: 8.29
Dissolved O2 value maximum concentration at start of test: 8.39
Dissolved O2 value maximum concentration at the end of the test: 8.25

Nominal and measured concentrations:

Nominal: 1 mg/L, 2,2 mg/L, 4,8 mg/L, 10 mg/L, 22 mg/L, 48 mg/L, 100 mg/L, 220 mg/L, 480 mg/L and 1000 mg/L
Measured: 1,01 mg/L, 2,21 mg/L, 4,83 mg/L, 10,06 mg/L, 22,13 mg/L, 48,27 mg/L, 100,6 mg/L, 221,3 mg/L, 482,7 mg/L and 1005,7 mg/L.

Details on test conditions:

Photoperiod: darkness
Test vessels: Test tubes (40 mL) capped with parafilm.
Test volume used: 10 mL
Number of test vessels per concentration: 4
Number of individuals per concentration: 20, divided into 5 individuals per test vessel
Age of individuals: less than 24 hours of life

Composition of culture medium OECD 202:
- Solution 1: CaCl 2 2H 2 O 11.76 g / L H 2 O
- Solution 2: MgSO 4 7H 2 O 4.93 g / L H 2 O
- Solution 3: NaHCO 3 2.59 g / L H 2 O
- Solution 4: KCl 0.23 g / L H 2 O
Add to 1000 mL of deionized water:
Solution 1 25 mL
Solution 2 25 mL
Solution 3 25 mL
Solution 4 25 mL

Reference substance (positive control):

yes

Remarks:

The reference substance used to verify the response of the test is potassium dichromate (K2Cr2O7). The result of periodic verification of the response of the test organisms is EC 50(24h) = 0.86 mg / L.

Key result

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

655 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mobility

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

175 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mobility

Validity criteria fulfilled:

yes

Remarks:

The validation criterion considered for this test is:: - the percentage of immobilisation observed in the control vessels is less than or equal to 10% - the EC50(24h) of potassium dichromate is between 0.6 mg / L and 1.7 mg / L

Conclusions:

The result obtained in this study indicates that the test substance has an EC50 value of 48h equal to 175 mg / l Daphnia Magna

Executive summary:

In this study of acute toxicity to aquatic invertebrates on the test substance, the Daphnia magna has been used for the determination of inhibition of mobility, according to the guidelines and methods OECD 202 (1984) and Royal Decree 363/1995 (BOE No. 133, June 1995).
The freshwater Daphnia magna has been exposed to the test substance, at the test concentrations: 1, 2.2, 4.8, 10, 22, 48, 100, 220, 480 and 1000 mg / L act. ingr. The total duration of the test has been 48 hours.
The result obtained in this test indicates that the test substance has an EC50 value (48h) equal to 175 mg / L act.ingr.

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

1984

Qualifier:

according to guideline

Guideline:

other: Real Decreto 363/1995 (BOE núm. 133 de Junio de 1995)

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

Taking into account the value of 27.4% of active ingredient, the study will be carried out with the 100% active ingredient of the presented material.
Preparation of the 3.65 g / L of the test material: 0.365 g of the test material has been dissolved in 100 mL of culture medium in a volumetric flask, Class A of 100 mL by means of agitation and a stock solution of 3650 mg / L has been obtained. The test material has a content of 27.4 % active material, thus the stock solution contains 1000 mg / L of active material. The different solutions used in the test have been prepared from this stock solution of 1000 mg / L.
Actual concentration of the stock solution: 1000.1 mg/L of active ingredient.

Test organisms (species):

Daphnia magna

Details on test organisms:

Strain: Daphnia magna, Strauss (Cladocera, Crustacea)
Age: ≤ 24-hours life, in good physiological conditions
Origin: Stirling University, United Kingdom

Culture conditions: The cultivation of daphnia from which the Individuals to carry out the test has been done with the following conditions:
- Temperature: between 18 and 22 ºC
- Photoperiod of 16 hours of light / 8 hours of darkness
- No aeration
- Feeding: Type of food: Chlorella (freshwater microalgae) and marine algae extract
- Frequency of feeding: 3 times / week

Test type:

not specified

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test temperature:

20 ± 2 ºC

pH:

Average pH value of culture at the beginning of the test: 7.65
pH value of culture medium at the end of the test: 7.37
pH Minimum concentration at the start of the test: 7.79
pH Minimum concentration at the end of the test: 7.39
pH value maximum concentration at start of test: 7.51
pH value maximum concentration at the end of the test: 7.29

Dissolved oxygen:

Dissolved O2 concentration values (mg / L):
Dissolved O2 value culture medium at the beginning of the test: 8.48
Dissolved O2 value culture medium at the end of the test: 8.36
Dissolved O2 value minimum concentration at start of test: 8.42
Dissolved O2 value minimum concentration at end of test: 8.33
Dissolved O2 value maximum concentration at start of test: 8.41
Dissolved O2 value maximum concentration at the end of the test: 8.31

Nominal and measured concentrations:

Nominal: 1 mg/L, 2,2 mg/L, 4,8 mg/L, 10 mg/L, 22 mg/L, 48 mg/L, 100 mg/L, 220 mg/L, 480 mg/L and 1000 mg/L
Measured: 1,00 mg/L, 2,20 mg/L, 4,80 mg/L, 10,00 mg/L, 22,00 mg/L, 48,00 mg/L, 100,0 mg/L, 221,0 mg/L, 480,0 mg/L and 1001,1 mg/L.

Details on test conditions:

Photoperiod: darkness
Test vessels: Test tubes (40 mL) capped with parafilm.
Test volume used: 10 mL
Number of test vessels per concentration: 4
Number of individuals per concentration: 20, divided into 5 individuals per test vessel
Age of individuals: less than 24 hours of life

Composition of culture medium OECD 202:
- Solution 1: CaCl2*H2O 11.76 g/L H2O
- Solution 2: MgSO4*7H2O 4.93 g/L H2O
- Solution 3: NaHCO3 2.59 g/L H2O
- Solution 4: KCl 0.23 g/L H2O
Add to 1000 mL of deionized water:
Solution 1 25 mL
Solution 2 25 mL
Solution 3 25 mL
Solution 4 25 mL

Reference substance (positive control):

yes

Remarks:

The reference substance used to verify the response of the test is potassium dichromate (K2Cr2O7).

Key result

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

660 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mobility

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

155 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mobility

Results with reference substance (positive control):

The EC50-24h of potassium dichromate is between 0.6 mg / L and 1.7 mg / L: The result of periodic verification of the response of the test organisms is EC 50(24h) = 0.86 mg / L.

Validity criteria fulfilled:

yes

Remarks:

The validation criterion considered for this test is:: - the percentage of immobilisation observed in the control vessels is less than or equal to 10% - the EC50(24h) of potassium dichromate is between 0.6 mg / L and 1.7 mg / L

Conclusions:

The result obtained in this study indicates that the test substance has an EC50 value of 48h equal to 155 mg / l Daphnia Magna

Executive summary:

In this study of acute toxicity to aquatic invertebrates on the test substance, the Daphnia magna has been used for the determination of inhibition of mobility, according to the guidelines and methods OECD 202 (1984) and Royal Decree 363/1995 (BOE No. 133, June 1995).
The freshwater Daphnia magna has been exposed to the test substance at the test concentrations: 1, 2.2, 4.8, 10, 22, 48, 100, 220, 480 and 1000 mg / L nominal. The total duration of the test has been 48 hours.
The result obtained in this test indicates that the test substance has an EC50 value (48h) equal to 155 mg / L act.ingr.

Description of key information

There are two studies conducted on the substance Direct Red 254 TEA salt (CAS 64683-40 -5) according to the OECD Guideline 202 to determine the short-term toxicity to Daphnia. The EC50 (48h) values 155 mg/L active ingr. and 175 mg/L active ingr. obtained in these two studies, show that the tested substance is not harmful to aquatic invertebrates.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

155 mg/L