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

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07/06/2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

no

Analytical monitoring:

not specified

Vehicle:

no

Details on test solutions:

A stock solution has been prepared with a concentration of 2.857 g/L of the test material. Therefore, 2.857 g of the test material have been dissolved in 1000 mL of water in a volumetric flask, Class A 1000 mL by stirring and resulting on a stock solution of 1000 mg/L. Because the test material contains 35% of active ingredient, the stock solution is of a concentration of 1000 mg/L of active material.
The different solutions used in the test have been prepared from this stock solution of 1000 mg/L active material.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

(Teleostei, Cyprinidae) (Hamilton-Buchanan) (pez cebra)
Procedencia: P & S, S.L
- size (cm): 2.86 ± 0,18
- weight (g): 0.29 ± 0,12
- Maintenance conditions:
o Temperature: 22 ºC ± 2
o Photoperiod: 12 hours of ligth / 12 hours of darkness
o Concentration of dissolved oxigen:> 60%
o Feeding:
· Feed type: Commercial flakes for fish feeding
· Frequency of feeding: 3 times/week, until 24 hours before the start of the test
· Acclimatization: minimum 12 days
· Mortality: 0%

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

120 mg CaCO3/L

Test temperature:

22 ºC ± 2

pH:

8,11

Dissolved oxygen:

> 70%

Nominal and measured concentrations:

nominal: 0,1 mg/L, 1 mg/L, 10 mg/L y 100 mg/L active material, plus one control (only water)
measured: 0,10 mg/L, 1,00 mg/L, 10,00 mg/L y 100,04 mg/L active material

Reference substance (positive control):

yes

Duration:

96 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Sublethal observations / clinical signs:

Number of died fishes during the test

conc (mg/L)
	0h	24h	48h	72h	96h
control	0	0	0	0	0
0.1	0	0	0	0	0
1	0	0	0	0	0
10	0	0	0	0	0
100	0	0	0	0	0

Validity criteria fulfilled:

yes

Conclusions:

The test material does not produces any mortality in Brachydario rerio at the concentration of 100 mg/L of active material.

Description of key information

The short-term toxicity to fish is determined by read-across to the structural analogue substance Direct Red 254 TEA salt (CAS 64683-40 -5). One test conducted according to the OECD Guideline 203 (Fish, Acute Toxicity Test) resulted on one EC50>100 mg/L, and at the maximum concentration tested no deaths were observed. These results lead to the conclusion that the substance is not harmful to fish.

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). TheEC50 (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 fish

Fresh water fish

Effect concentration:

100 mg/L