A mixture of: sodium/potassium 7-[[[3-[[4-((2-hydroxy-naphthyl)azo)phenyl]azo]phenyl]sulfonyl]amino]-naphthalene-1,3-disulfonate

Toxicity to soil macroorganisms except arthropods

Link to relevant study record(s)

Reference

Endpoint:

toxicity to soil macroorganisms except arthropods: short-term

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07 July 1992 to 14 October 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 207 (Earthworm, Acute Toxicity Tests)

Deviations:

yes

Remarks:

The temperature in the test room reached at times 23-27 °C, which has only little influence on the mortality of the worms

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Code number: FAT45155/B
Batch number: TV1
Appearance: solid
Solubility: ~100g/l (in water) [estimation]
Stability in water: >2 h
Storage: at room temperature, in the dark
Expiration date: 15.5.1997

Analytical monitoring:

no

Vehicle:

no

Details on preparation and application of test substrate:

The test substance was dissolved in bidistilled water and then added to the artificial soil before test start.

Test organisms (species):

Eisenia fetida

Animal group:

annelids

Details on test organisms:

- Source: RCC
- Condition: Standardised condition according to OECD 207
- Age: Adult worms (older than two months)
- Average body weight: 300-600 mg
- Acclimate Soil: Artificial soil for 24 h prior to experimental start

Study type:

laboratory study

Substrate type:

artificial soil

Limit test:

no

Total exposure duration:

14 d

Test temperature:

20 ± 2 °C, at times 23-27 °C

pH:

5.6-6.1

Moisture:

test start: 35.8-37.2 %
test end: 35.4-36.7 %

Details on test conditions:

- No. of replicates per treatment group: 4
- No. of replicates per control: 4

Nominal and measured concentrations:

nominal: 0.1, 1.0, 10.0, 100.0 and 1000.0 mg/kg artificial soil (dry weight)(range finding test & main test)

Reference substance (positive control):

yes

Remarks:

Chloracetamide

Duration:

7 d

Dose descriptor:

LC50

Effect conc.:

> 1 000 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Duration:

14 d

Dose descriptor:

LC50

Effect conc.:

> 1 000 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Results with reference substance (positive control):

LC50 (14 d) = 7.53 mg/kg artificial soil (95 % confidence range: 6.55-8.65 mg/kg).

Reported statistics and error estimates:

It was not possible to calculate the LC50 and its 95 % confidence limits at days 7 and 14.

pH and water content of the artificial soil

During the entire study, the pH of the artificial soil was in a range of 5.6 to 6.1 and did not deviate from the values allowed by the guidelines (6.0 ± 0.5). The water capacity of the artificial soil was determined to be 54 % of the dry weight at the begin of the study. The water content was ca. 35.8 % to 37.2 % (dry weight) at start and in a range from 35.4 % to 36.7 % at the end of the study. This does not differ significantly from the value given by the guidelines (ca. 35 %).

 

Mortality and body weights of E foetida

The results of this study did not reveal any toxic effects of FAT 45155/B to Eisenia foetida. Only two of the 60 worms involved in the experiment died within the 14 days of experimental time and this mortality was clearly not caused by the test substance. According to this results it was not possible to calculate the LC50 (14 days) of FAT 45155/B to Eisenia foetida, which in artificial soil clearly must be more than 1000 mg/kg. In all test concentrations, the body weights of the surviving worms decreased slightly due to the starvation of the animals within the test period. No behavioural abnormalities could be observed.

Validity criteria fulfilled:

yes

Conclusions:

FAT 45155/B did not cause any acute toxic effects to Eisenia foetida in artificial soil up to a concentration of 1000 mg/kg.

Executive summary:

A GLP-compliant test was performed to determine the toxic effects of test substance on the acute toxicity during 14 days according to OECD TG 207. 0.1, 1.0. 10.0, 100.0, 1000.0 mg/kg artificial soil of test substance were applied in the range finding test and the definitive test. The reference substance of Chloracetamide was also applied. The test was considered valid based on the control mortality and the result of the reference substance. The results of this study did not reveal any toxic effects of FAT 45155/B to Eisenia foetida. Only two of the 60 worms involved in the experiment died within the 14 days of experimental time and this mortality was clearly not caused by the test substance. In all test concentrations, the body weights of the surviving worms decreased slightly due to the starvation of the animals within the test period. No behavioural abnormalities could be observed. The results indicated the LC50 of the test substance was above 1000 mg/kg artificial soil. Thus, FAT 45155/B did not cause any acute toxic effects to Eisenia foetida in artificial soil up to a concentration of 1000 mg/kg, the highest tested concentration.

Description of key information

14 d LC50 of test substance to E foetida was > 1000 mg/kg soil dw.

Key value for chemical safety assessment

Short-term EC50 or LC50 for soil macroorganisms:

1 000 mg/kg soil dw

Additional information

A GLP-compliant test was performed to determine the toxic effects of test substance on the acute toxicity during 14 days according to OECD TG 207. 0.1, 1.0. 10.0, 100.0, 1000.0 mg/kg artificial soil of test substance were applied in the range finding test and the definitive test. The reference substance of Chloracetamide was also applied. The results of this study did not reveal any toxic effects of FAT 45155/B to Eisenia foetida. Only two of the 60 worms involved in the experiment died within the 14 days of experimental time and this mortality was clearly not caused by the test substance. In all test concentrations, the body weights of the surviving worms decreased slightly due to the starvation of the animals within the test period. No behavioural abnormalities could be observed. The results indicated the LC50 of the test substance was above 1000 mg/kg artificial soil. Thus, FAT 45155/B did not cause any acute toxic effects to Eisenia foetida in artificial soil up to a concentration of 1000 mg/kg, the highest tested concentration.