3-methyl-6-(p-toluidino)-3H-dibenz[f,ij]isoquinoline-2,7-dione

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:

2017

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

Remarks:

Some test fish had a somewhat larger size than the one recommended in the test guideline for the zebra fish. This deviation is not regarded to be relevant to the results

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Vehicle:

no

Details on test solutions:

Pre-treatment of test item and preparation of test item concentrations
A direct weighing was prepared daily to produce the only test item concentration. To achieve this 500 mg of the test item were added daily to 5 litres of dilution water, treated for 1 h in an ultrasonic bath and stirred for 24 h on a magnetic stirrer. Undissolved particles of the test item were removed by filtration using a folded filter with a pore size of 7-12 μm.
The pH value was measured and ranged between pH 7.4 and 7.6 in the freshly prepared solution.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

Name : Zebra fish (Danio rerio)
Source : Interaquaristik.de Shop (Germany)
Date supplied : 2017-07-04
Acclimatisation : Stock held since 2017-07-04 and acclimatised to the test conditions since then.
Temperature : 20 - 24 °C
Dissolved oxygen : > 5 mg/L
Feeding : Commercial fish food, daily. Feeding discontinued 24 h prior to test start.
Mortalities during acclimatisation period : < 5 %
Medication : none
Mean standard length (n = 14) : 3.61 cm (S.D. = 0.12 cm)

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Remarks on exposure duration:

Daily renewal ob test solutions.

Hardness:

The hardness of the dilution water used was 13.2 °dH (= 236 mg/L CaCO3).

Test temperature:

22°C

pH:

7.5

Dissolved oxygen:

8.1-8.9 mg/L

Salinity:

n.a.

Conductivity:

No data

Nominal and measured concentrations:

The effect levels are given in nominal concentrations. Analytical monitoring showed that due to the low water solubility, only very low concentrations of Solvent Red 52 were found in the region of 25 to 114 µg/L with a geometric mean of 50 µg/L..

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 50.9 µg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

All results are expressed in terms of geometric mean measured concentrations. Effective concentrations ranged from 0.025 % to 0.114 % of nominal values in the freshly prepared medium and from 0.026 % to 0.074 % of nominal values in the medium after 24 hours of exposure.

Validity criteria fulfilled:

yes

Remarks:

The mortality in the controls did not exceed 10 % by the end of the test; the dissolved oxygen concentration remained above 60 % of the air-saturation value throughout the exposure period; the pH did not vary by more than 1 unit

Conclusions:

No toxic effects against fish were observed at the limit of water solubility under exposure conditions. All results are expressed in terms of geometric mean measured concentrations. Effective concentrations ranged from 0.025 % to 0.114 % of nominal values in the freshly prepared medium and from 0.026 % to 0.074 % of nominal values in the medium after 24 hours of exposure.

Executive summary:

According to the EU-Method C.1 'Acute toxicity for Fish' (2008) which is in most parts equivalent to the OECD Guideline for Testing of Chemicals No. 203 'Fish, Acute Toxicity Test' (1992) a group of seven fish of the recommended size was exposed to a limit test concentration of Solvent Red 52 dissolved in dilution water. Because of the anticipated low toxicity of the test item, fish were exposed in the main test to a limit test concentration of nominally 100 mg/L for a period of 96 hours. As no toxic effects against fish were observed, no statistical analysis was required to determine the LC 50. Additionally any abnormal behaviour or appearance of the fish was reported every 24 hours. The main test was conducted as semi-static test with daily renewal of test solutions. During the test a temperature range of 20 - 24 °C was maintained in the test vessels, with a maximum temperature fluctuation of +/- 0.6 °C in the test. The temperature, the pH and the oxygen values were measured at the beginning of the test and every 24 hours thereafter. The temperature, the pH and the oxygen values were measured every day in the freshly prepared media and in the media after 24 hours of exposure. The validity criteria of the test were met. No toxic effects against fish were observed at the limit of water solubility under exposure conditions. All results are expressed in terms of geometric mean measured concentrations. Effective concentrations ranged from 0.025 % to 0.114 % of nominal values in the freshly prepared medium and from 0.026 % to 0.074 % of nominal values in the medium after 24 hours of exposure.

This toxicity study is classified as acceptable and satisfies the guideline requirements for the acute fish study.

Description of key information

No toxic effects against fish were observed at the limit of water solubility under exposure conditions.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L

Additional information

"Should read: LC 50 >100 mg/L (nominal)"