1-hydroxy-4-[[4-[(methylsulphonyl)oxy]phenyl]amino]anthraquinone

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

29 December, 1993 to 11 May, 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

Test substance
Code number: FAT - 36'038/F
En-Nr.: 409753.32
Purity 69.4 %
Appearance: solid
Solubility: in water <0.1 g/L; in DMF soluble
Storage: room temperature
Expiration date: 09/98

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 100 mg/l of FAT 36038/F
- The quantification of FAT 36038/F was performed by measuring the UV-signal of samples at 252 nm after HPLC separation.
- Sample storage conditions before analysis: The samples were stored deep frozen and protected from light until analysis was performed.

Vehicle:

yes

Details on test solutions:

According to the results of pre-experiments to the solubility of the test substance, FAT 36038/F could be dissolved respectively suspended in water at a concentration of nominal 100 mg/l. However, after 24 hours a great part of the test substance had precipitated and settled at the bottom.
Therefore, the emulsifier Tween 80 was used for the preparation of a concentrated homogeneous stock suspension. This stock suspension could be mixed homogeneously into water up to a test concentration of nominal 100 mg test substance/l and a lower part of the test substance precipitated and settled at the bottom than in the pre-experiment without emulgator.
These pre-experiments to the solubility and the dosage of the test substance were not performed in compliance with GLP-Regulations.

Test organisms (species):

Daphnia magna

Details on test organisms:

The study was performed with young Daphnia (at the start of the test 6 - 24 hours old) of a clone of the species Daphnia magna Straus. The clone is bred in the laboratories of RCC under standardized conditions. The cultivation of the parental Daphnia was performed in reconstituted water of a similar quality regarding to pH, components of the main ions and total hardness as the test water used in the test.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Post exposure observation period:

None

Hardness:

2.5 mmol/l (=250 mg/l) as CaCO3

Test temperature:

20.6 - 20.9 °C during the test period

pH:

7.6 - 7.7 (start of experiment)
8.0 (end of experiment)

Dissolved oxygen:

8.6 - 8.7 mg/L (start of experiment)
9.2 - 9.5 (end of experiment)

Salinity:

Not applicable

Nominal and measured concentrations:

- nominal concentration: 100 mg/l
- measured concentrations: 84.2 mg/l (84.2 % of the nominal concentration)

Details on test conditions:

In the only test concentration (nominal 100 mg/L), in the control and in the solvent control 20 Daphnia were tested, divided into four groups of five animals, each group in 200 ml test medium in a glass-beaker (250 ml). The Daphnia were not fed during the test period. The test was performed in an air-conditioned room.
- Light: 16 hours per day, approximately 200 - 600 Lux.
The Daphnia have not been fed, and the test media have not been airated during the test period.

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC0

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: The 48-hour EC50 of the test substance could not be determined due to the low toxicity of the test substance.

Details on results:

Analytical results:
The analytically determined test substance concentrations in the test media decreased from 89.1 % of the nominal value at the start of the test to 79.2 % at the end of the test. This decrease was obviously caused by the low solubility of the test substance in the test water, since in the biological test it was observed that after 24 and 48 hours test period a small part of the test substance had precipitated and was lying at the bottom of the test beakers. The mean value of the measured concentrations in the samples from the start and the end of the test amounted to 84.2 % of the nominal concentration of 100 mg/l. The reported biological results are related to the nominal test concentration as well to the mean measured test substance concentration of 84.2 mg/l

Biological results:
A limit test was performed in accordance with the EEC test guideline to demonstrate that the test substance has no toxic effect on the test animals up to the concentration of nominal 100 mg test substance/l. Concentrations in excess of nominal 100 mg test substance/l have not been tested.

In the control, the solvent control and in the only test concentration of nominal 100 mg test substance/l no immobilized or dead test animal was observed during the test period of 48 hours.

Therefore, the 48-hour NOEC (highest tested concentration without toxic effects after the exposure period of 48 hours), respectively the 48-hour EC0 of FAT 36038/F to Daphnia magna was determined to be at least nominal 100 mg test substance/l (mean measured concentration: 84.2 mg/l). Since concentrations in excess of nominal 100 mg test substance/l have not been tested, the NOEC might even be higher than this concentration. The 48-hour EC50 of the test substance could not be determined due to the low toxicity of the test substance.

During the test period the dissolved oxygen concentrations in the test media were always 8.6 mg/l or higher, the pH-values in the range from pH 7.6 to 8.0.

Results with reference substance (positive control):

Not applicable

Reported statistics and error estimates:

None

Dossilved oxygen concentrations (mg/l) and pH-values in the media at the start and end of the test.

	Start (0 hour)		End (48 hours)
Nominal conc. of test subst. (mg/L)	pH	Oxygen	pH	Oxygen
Control	7.6	8.6	8.0	9.5
Solvent control	7.6	8.6	8.0	9.2
100	7.7	8.7	8.0	9.2

Influence of FAT 36038/F on the mobility of Daphnia magna.

		No of immobilized daphnia after:		% of immobilized daphnia after:
Nominal conc. of test subst. (mg/l)	N° of Daphnia tested	24 hours	48 hours	24 hours	48 hours
Control	20	0	0	0	0
Solvent control	20	0	0	0	0
100	20	0	0	0	0

Validity criteria fulfilled:

yes

Conclusions:

The 48h EC50 of the test substance could not be determined due to the low toxicity of the test substance and considered to be >100 mg/L.

Executive summary:

The acute toxicity of the test substance FAT 36038/F to Daphnia magna was determined in a 48-hour static test according to the Commission Directive 92/69/EEC, Annex Part C.2, dated December 29, 1992 and the OECD Guideline for Testing of Chemicals, Section 2, No. 202, Part I, adopted April 04, 1984. The test was performed in compliance with Good Laboratory Practice Regulations.

A limit test was performed in accordance with the EEC test guideline to demonstrate that the test substance has no toxic effect on the test animals up to the concentration of nominal 100 mg test substance/L. Concentrations in excess of nominal 100 mg test substance/L have not been tested. The emulsifier Tween 80 was used (100 mg/L) for the preparation of a concentrated homogeneous stock suspension and to keep the test substance in suspension as far as possible.

The analytically determined test substance concentrations in the test media decreased from 89.1 % of the nominal value at the start of the test to 79.2 % at the end of the test, obviously caused by the low solubility of the test substance in the test water. The reported biological results are related to the nominal test concentration as well to the mean measured test substance concentration of 84.2 mg/l (84.2 % of the nominal concentration).

No immbolisation of daphnia was observed at the nominal concentration of 100 mg/L. Hence, the 48h NOEC and the 48h EC0 of FAT 36038/F to Daphnia magna was determined to be at least nominal 100 mg test substance/l (mean measured concentration: 84.2 mg/l). Since concentrations in excess of nominal 100 mg test substance/l have not been tested, the NOEC might even be higher than this concentration. The 48h EC50 of the test substance could not be determined due to the low toxicity of the test substance.

Description of key information

The 48h EC50 to Daphnia magna was determined to be >100 mg test substance/L.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

100 mg/L

Additional information

The acute toxicity of the test substance FAT 36038/F to Daphnia magna was determined in a 48-hour static test according to the Commission Directive 92/69/EEC, Annex Part C.2, dated December 29, 1992 and the OECD Guideline for Testing of Chemicals, Section 2, No. 202, Part I, adopted April 04, 1984. The test was performed in compliance with Good Laboratory Practice Regulations.

A limit test was performed in accordance with the EEC test guideline to demonstrate that the test substance has no toxic effects on the test animals up to the concentration of nominal 100 mg test substance/l. Concentrations in excess of nominal 100 mg test substance/L have not been tested. The emulsifier Tween 80 was used (100 mg/L) for the preparation of a concentrated homogeneous stock suspension and to keep the test substance in suspension as far as possible.

The analytically determined test substance concentrations in the test media decreased from 89.1 % of the nominal value at the start of the test to 79.2 % at the end of the test, obviously caused by the low solubility of the test substance in the test water. The reported biological results are related to the nominal test concentration as well to the mean measured test substance concentration of 84.2 mg/L (84.2 % of the nominal concentration).

No immbilisation of daphnia was observed at the nominal concentration of 100 mg/L. Hence, the 48h NOEC and the 48h EC0 of FAT 36038/F to Daphnia magna was determined to be at least nominal 100 mg test substance/l (mean measured concentration: 84.2 mg/L). Since concentrations in excess of nominal 100 mg test substance/L have not been tested, the NOEC might even be higher than this concentration. The 48h EC50 of the test substance could not be determined due to the low toxicity of the test substance.