Disodium 7-amino-4-hydroxy-3-[[4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulphonate

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

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:

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 20% of active ingredient, the study will be carried out with the 100% active ingredient of the presented material.
Preparation of the 1 g / L of the test material : 1 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 1000 mg / L has been obtained. The test material has a content of 20% active material, thus the stock solution contains 200 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: 1007 mg/L of active ingredient.

Test organisms (species):

Daphnia magna

Details on test organisms:

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 value pH at the beginning of the test: 7,62 (interval 7,66-7,81)
average value pH at the end of the test: 7,39 (interval 7,42-7,76)

Dissolved oxygen:

average value O2 at the beginning of the test: 8,52 mg/L (interval 8,52-8,49 mg/L)
average value O2 at the end of the test: 8,41 mg/L (interval 8,39-8,3

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, 2,22 mg/L, 4,83 mg/L, 10,07 mg/L, 22,15 mg/L, 48,35 mg/L, 100,7 mg/L, 221,5 mg/L, 483,4 mg/L and 1007 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:

Potassium dichromate

Key result

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

> 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Key result

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

> 200 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mobility

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 200 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

Validity criteria fulfilled:

yes

Conclusions:

The result obtained in this test indicates that the test substance is not toxic to Daphnia magna at the concentration of 200 mg / L of active material.

Description of key information

There is one study available to determine the short-term toxicity of the substance Direct Red 254 sodium salt (CAS 6300 -50 -1) to Daphnia according to OECD Guideline 202. At the maximum concentration tested (EC50(daphnia)>200 mg/L act. ingr.) and considering the existing information, the substance is not harmful to aquatic invertebrates.

There are two additional studies conducted on the structural analogue substance Direct Red 254 TEA salt (CAS 64683-40 -5). The EC50 (48h) values are 155 mg/L active ingr. and 175 mg/L active ingr. respectively, show that the tested substance is not harmful to aquatic invertebrates.

The tested substances have an identical structure in respect to the anionic constituents.

The results of all the studies support the effect of the substance to aquatic invertebrates and the read-across approach between both structures.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

200 mg/L