trisodium 3-amino-4-[4-[4-(2-(2-ethenylsulfonylethoxy)ethylamino)-6-fluoro-1,3,5-triazine-2-ylamino]-2-sulfophenylazo]-5-hydroxynaphthalene-2,7-disulfonate

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:

Study initiation date - 12 March 1999; Experiment start date - 15 March 1999; Experiment completion date - 31 March 1999; Study completion date - 19 May 1999.

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 (incl. QA statement)

Specific details on test material used for the study:

Identity: FAT 40'574/B
Batch: WP 23/99
Purity: Approx. 75 %
Appearance: Solid, dark-red powder
Storage: At room temperature at about 20 °C
Expiration Date: 08 February 2006

Analytical monitoring:

yes

Details on sampling:

The test water samples for the analytical determinations were taken from the fish tanks at the beginning, after 48 hours and at the end of the experiment. Samples of the test solutions were taken from the approximate centre of the test vessels after mixing of the medium. The samples were kept at -18 °C to -30 °C until analysis. The test concentrations below the NOEC were not analysed and have not been taken for the determination of the results.

Vehicle:

no

Details on test solutions:

Identity and concentration of auxiliary solvent for dispersal: None

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

The test organisms were zebra-fishes (Brachydanio rerio), supplied by Charles River Aquatics, Someren, Netherlands. The quality of the fish was assessed by an acclimatisation time of 47 days in dechlorinated tap water. For each treatment, 7 fish were used. The fish were not fed during the test.
Weight of fish: 0.13 g (average)
Length of fish: 23.5 mm (average)
Fish age; 137 days
Treatment: none

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

142 mg CaCO3/L

Test temperature:

22 ± 1

pH:

8.0 - 8.4

Dissolved oxygen:

91 - 97

Nominal and measured concentrations:

Nominal concentration: 100 mg/L

Details on test conditions:

Light: Daylight
Apparatus: Static test in 5 litre glass aquaria with a test volume of 2.88 - 2.96 litre (3.0 litre minus 6x 20 ml for analytical samples), slowly aerated. A range-finding test was carried out with concentrations from 0.1 to 100 mg/l. For the definitive test a limit test exposing the fish to a 100 mg/l of the test substance was conducted. Additionally, a blank control without test substance was tested. 300 mg of test substance were mixed with 250 ml dechlorinated tap water and then added up to 3.0 litres. The test substance was completely dissolved in the test water.

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

In the range-finding test no mortality was observed in the test concentrations up to 100 mg/l nominal. Hence in the definitive test a limit test exposing the fish to 100 mg/L of test substance was carried out. Additionally, a blank control without test substance was tested. The actual test concentrations in the analyzed test medium were in the range of 95.4 - 99.9 % of the nominal values. Since the measured concentrations of the test substance correlated well with the nominal values, results are based on nominal values. No mortality was observed at a test concentration of 100 mg/L following a 96 h exposure period. In the blank control one mortality occurred after 72 hours. However, this is still within the limits set by the guidelines and hence the test is considered valid. No abnormal behaviour or symptoms were observed in any of the fish throughout the test period. Mortalities and sublethal symptoms observed are presented in Table 1 and 2, respectively. The NOEC and the LC0) value after 96 hours was determined to be 100 mg/l. The LC50 value after 96 was calculated to be >100 mg/l.

Analytical results: The test concentration in the analyzed test media was 95.4 - 99.9 % of the nominal values.

Sublethal observations / clinical signs:

Validity of the test

The test was considered valid because

• The mortality in the control did not exceed one fish at the end of the test

• the oxygen concentration throughout the test was >60 % of the air saturation

Validity criteria fulfilled:

yes

Conclusions:

The LC50 for FAT 40574/B was determined to be >100 mg/L.

Executive summary:

A GLP-compliant study was performed to determine the toxic effects of test substance to zebra fish during 96 hours according to OECD TG 203. For this purpose, zebra fish {Brachydanio rerio) were exposed in a static non-renewal test to an aqueous test medium at the nominal concentration of 100 mg/L under defined conditions. The decision to perform a limit test was based on the results of a range-finding test. 100 mg/L of test substance and a control were applied in the limit test. The LC50, LOEC and LC100 could not be quantified due to the absence of a toxic effect of the test item at the tested concentration. But it indicated LC50, LC100 and NOEC of the test substance were all above 100 mg/L. Thus, we can consider the test substance is low toxicity to zebra fish and is not classified as per EU CLP (Regulation (EC) No 1272/2008).

Description of key information

The LC50 of FAT 40574/B was determined to be >100 mg/L

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L

Additional information

A GLP-compliant study was performed to determine the toxic effects of test substance to zebra fish during 96 hours according to OECD TG 203. For this purpose, zebra fish {Brachydanio rerio) were exposed in a static non-renewal test to an aqueous test medium at the nominal concentration of 100 mg/L under defined conditions. The decision to perform a limit test was based on the results of a range-finding test. 100 mg/L of test substance and a control were applied in the limit test. The LC50, LOEC and LC100 could not be quantified due to the absence of a toxic effect of the test item at the tested concentration. But it indicated LC50, LC100 and NOEC of the test substance were all above 100mg/L. Thus, we can consider the test substance is low toxicity to zebra fish and is not classified as per EU CLP (Regulation (EC) No 1272/2008).