reaction mass of: tetrasodium 7-(4-(4-fluoro-6-(4-(2-sulfonatoethylsulfonyl)phenylamino)-1,3,5-triazin-2-ylamino)-2-ureidophenylazo)naphthalene-1,3,6-trisulfonate;tetrasodium 7-(4-(4-hydroxy-6-(4-(2-sulfonatoethylsulfonyl)phenylamino)-1,3,5-triazin-2-ylamino)-2-ureidophenylazo)naphthalene-1,3,6-trisulfonate

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:

09 February 1998 to 13 February 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted to recent EU & OECD test guidance in compliance with GLP

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
None

Analytical monitoring:

no

Details on sampling:

- Concentrations: 0/100 mg/l

Vehicle:

no

Details on test solutions:

The test substance was weighed into a beaker. Water for dilution was added, the mixture was homogenized using an Ultra-Turrax and poured into the chamber under stirring with a glass rod.

In order to determine the substance concentration, water samples were taken from the middle of the test chamber by pipetting approx. 20 mL into a screw-neck glass bottle at study start, and after 48 and 96 hours.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebra fish
- Source: Hoechst Marion Roussel Deutschland GmbH
- Length at study initiation (length definition, mean, range and SD): cm, 2.8, 2.5-3.1, ±2
- Feeding during test: No

ACCLIMATION
- Acclimation period: 14 days
- Acclimation conditions (same as test or not): same as test
- Feeding frequency: twice daily, ad libitum
- Health during acclimation (any mortality observed): No

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Post exposure observation period:

No post exposure observation

Hardness:

No data

Test temperature:

21.4-21.7°C

pH:

7.4-7.9

Dissolved oxygen:

6.9-9.8 mg/l

Salinity:

Not applicable - freshwater

Nominal and measured concentrations:

100 mg/L (nominal)

Details on test conditions:

The study was conducted in a static system. The test chambers, which were calibrated to 4 liters, were made of glass (length 20 cm, width 15 cm, height 20 cm) and stood in a water bath made of Hostalit Z® with a Plexiglas viewing panel. The temperature of the water bath was regulated by a thermostat to 22 + 1 °C. The chambers were illuminated from above from 06.00 a.m to 06.00 p.m. The light intensity directly over the chambers was approximately 700 lux.

The test chambers were not aerated during the course of the study.

After the test concentrations had been prepared and water parameters recorded, 7 fish were assigned to each test and control chamber. The fish received no feed for the entire study period. Inspection of the fish took place after 3, 6, 24, 48, 72 and 96 hours and involved recording the lethality and visible changes in appearance and behavior. Dead fish were removed from the chambers. Fish were considered dead when there was a lack of opercular movement and no response to slight mechanical stimulus. The water parameters were measured and recorded before study start and after 0, 24, 48, 72 and 96 hours.

Reference substance (positive control):

no

Duration:

24 h

Dose descriptor:

LC0

Effect conc.:

100 mg/L

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

48 h

Dose descriptor:

LC0

Effect conc.:

100 mg/L

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

72 h

Dose descriptor:

LC0

Effect conc.:

100 mg/L

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

100 mg/L

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

72 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

In the control and in the 100 mg/L concentration group no lethality was observed. In the concentration group the fish showed changes in behavior and respiration rate. The effects were reversible within 96 hours of exposure.

In this 96-hours acute toxicity study in zebra fish (Danio rerio) no lethality occurred in the 100 mg/L group and the control group.

Results with reference substance (positive control):

Not applicable

Reported statistics and error estimates:

Not reported.

Sublethal observations / clinical signs:

	after 24 hours	after 48 hours	after 72 hours	after 96 hours
LC0 (mg/L)	100	100	100	100
LC50 (mg/L)	> 100	> 100	> 100	> 100
LC100 (mg/L)	not determined	not determined	not determined	not determined

Validity criteria fulfilled:

yes

Conclusions:

In the control and in the 100 mg/L concentration group no lethality was observed. In the concentration group the fish showed changes in behavior and respiration rate. The effects were reversible within 96 hours of exposure.

In this 96-hours acute toxicity study in zebra fish (Danio rerio) no lethality occurred in the 100 mg/L group and the control group.

Under the conditions of this test the LC50 of the substance after 96 hours was > 100 mg/L.

Executive summary:

A study was conducted according to EU test guidance 92/69/EEC part C1 and OECD test guideline 203 in compliance with GLP.

In the control and in the 100 mg/L concentration group no lethality was observed. In the concentration group the fish showed changes in behavior and respiration rate. The effects were reversible within 96 hours of exposure.

The LC50 was above 100 mg/L after 96 hours. The substance is not considered to pose a hazard to fish.

Description of key information

The LC50 was above 100 mg/L after 96 hours. The substance is not considered to pose a hazard to fish.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L

Additional information

A study was conducted according to EU test guidance 92/69/EEC part C1 and OECD test guideline 203 in compliance with GLP.

In the control and in the 100 mg/L concentration group no lethality was observed. In the concentration group the fish showed changes in behavior and respiration rate. The effects were reversible within 96 hours of exposure.

The LC50 was above 100 mg/L after 96 hours. The substance is not considered to pose a hazard to fish.