Reaction mass of Cobaltate(3-), bis[2-[[[3-[2-[1-[[(2-chlorophenyl)amino]carbonyl]-2-(oxo-κO)propyl]diazenyl-κN1]-4-(hydroxy-κO)phenyl]sulfonyl]amino]benzoato(3-)]-, sodium (1:3) and tetrasodium bis[2-[[[3-[[1-[(2-chloroanilino)carbonyl]-2-oxopropyl]azo]-4-hydroxyphenyl]sulphonyl]amino]benzoato(3-)]cobaltate(4-)

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:

1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

Test substance: FAT 20049/G
Batch no: EN 007379.71
Purity: ca. 65 %
Appearance: yellow powder
Solubility: 100 g/l
Storage: Room temperature
Expiration date: 03/2003

Analytical monitoring:

not specified

Details on sampling:

no data

Vehicle:

yes

Details on test solutions:

Stock solution and test concentrations:
- Stock solution: 1000 mg test substance was dissolved in 200 mL dechlorinated tap water, was homogenized for 10 minutes by ultrasonic treatment and then added up to 1 L. For the preparation of the test concentrations the stock solution was mixed.
- Test concentrations: The nominal test concentrations were selected as 0.04, 0.08, 0.18, 0.40, 0.88, 1.9 and 4.3 mg/L. Additionally a blank control without test substance was tested.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

The test organism was the species Zebra fish (Brachydanio rerio) supplied by Charles River Aquatics, Someren, Netherlands. The quality of the fish was checked with an acclimatization time of 61 d in dechlorinated tap water. For each concentration, 7 fish were used. The fish were not fed during the test.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Post exposure observation period:

no data

Hardness:

142 mg CaCO3/L

Test temperature:

23 °C

pH:

7.9 - 8.4

Dissolved oxygen:

95 - 98 %

Salinity:

no data

Nominal and measured concentrations:

Nominal concentrations: 0, 0.04, 0.08, 0.18, 0.40, 0.88, 1.9 and 4.3 mg/L

Details on test conditions:

Light: Daylight
Apparatus: Static test in 5 L glass aquaria with a test volume of 3 L, slowly aerated.

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

0.08 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

ca. 0.052 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

0.52 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 0.31-0.94

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

ca. 0.33 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

1.9 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

ca. 1.24 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Details on results:

In the control and in the test concentration up to 0.08 mg/L, no mortality and no abnormal behaviour of the test fish were observed over the test period. Therefore, the NOEC and the LC0 value were determined to be 0.08 mg/L. The LC100 value was determined to be 1.9 mg/L nominal.

Results with reference substance (positive control):

no data

Reported statistics and error estimates:

The LC50 values were calculated with the Probit method.

Sublethal observations / clinical signs:

Validity of the test

The test was considered valid because

- no fish was dead in the control at the end of the test

- the oxygen concentration throughout the test was >60 % of the air saturation value.

Validity criteria fulfilled:

yes

Conclusions:

The 96 h LC50 was 0.52 mg/L (i.e. ca. 0.33 mg a.i./L) and the 96 h LC100 was 1.9 mg/L (i.e. ca. 1.24 mg a.i./L).

Executive summary:

A study was conducted to determine the short term toxicity (LC50) of the test substance (at ca. 65 % purity) to Zebra fish (Brachydanio rerio) according to OECD Guideline 203 and EU Method C.1 in compliance with GLP. Groups of 7 fish were exposed at nominal concentrations of 0, 0.04, 0.08, 0.18, 0.40, 0.88, 1.9 and 4.3 mg/L for 96 h. Mortality and behaviour were recorded at 24, 48, 72 and 96 h. No alteration of the test substance in the media was observed throughout the study. There was no mortality and no abnormal behaviour at concentrations up to 0.08 mg/L. Mortality and moderate symptoms were observed at all other concentration. All fishes were found dead at 1.9 mg/L concentration. Under the test conditions, the 96 h NOEC (LC0) to Zebra fish (Brachydanio rerio) was 0.08 mg/L (i.e. ca. 0.052 mg a.i./L). The 96 h LC50 was 0.52 mg/L (i.e. ca. 0.33 mg a.i./L) and the 96 h LC100 was 1.9 mg/L (i.e. ca. 1.24 mg a.i./L).

Description of key information

Several studies evaluating toxicity potential of Acid Yellow 220 are available. The study performed in1998 has been selected as key study and was conducted to determine the short-term toxicity (LC50) of the test substance (at ca. 65 % purity) to Zebra fish (Brachydanio rerio) according to OECD Guideline 203 and EU Method C.1 in compliance with GLP. Under the test conditions, the 96 h NOEC (LC0) to Zebra fish (Brachydanio rerio) was 0.08 mg/L (i.e. ca. 0.052 mg a.i./L). The 96 h LC50 was 0.52 mg/L (i.e. ca. 0.33 mg a.i./L) and the 96 h LC100 was 1.9 mg/L (i.e. ca. 1.24 mg a.i./L).

The outcomes of other studies available are presented below:

FAT 20049/E - 96h LC50: 15.7 mg/L

FAT 20049/D - 96h LC50: 13 mg/L

FAT 20049/C - 48h TL50: 0.63 mg/L and 6.3 mg/L

FAT 20049/B - 48h TL50: 0.63 mg/L

FAT 20049/A - 48h TL50: 4.4 mg/L

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

0.33 mg/L