Reaction mass of lithium sodium hydrogen 4-amino-6-({5-[(5-chloro-2,6-difluoropyrimidin-4-yl)amino]-2-sulfonatophenyl}diazenyl)-5-hydroxy-3-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]naphthalene-2,7-disulfonate and lithium sodium hydrogen 4-amino-6-({5-[(5-chloro-2,6-difluoropyrimidin-4-yl)amino]-2-sulfonatophenyl}diazenyl)-5-hydroxy-3-{[4-(vinylsulfonyl)phenyl]diazenyl}naphthalene-2,7-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:

12-07-2001 to 26-07-2001

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:

no

Qualifier:

according to guideline

Guideline:

EU Method C.8 (Toxicity for Earthworms: Artificial Soil Test)

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

no

Vehicle:

no

Test organisms (species):

Eisenia fetida

Animal group:

annelids

Details on test organisms:

TEST ORGANISM
- Common name: Earthworm
- Source: ECT GmbH
- Age at test initiation (mean and range, SD): approximately 5 months (adult with clitellum)
- Weight at test initiation (mean and range, SD): 300-600 mg (wet weight)

ACCLIMATION
- Acclimation period: 48 h
- Acclimation conditions (same as test or not): same

Study type:

laboratory study

Substrate type:

artificial soil

Limit test:

no

Total exposure duration:

14 d

Test temperature:

18-22°C

pH:

6.1-6.5

Moisture:

32-38%

Details on test conditions:

TEST SYSTEM
- Test container (material, size): 2 L glass beaker (covered with perforated plastic film at the start of test to reduce evaporation)
- Amount of soil or substrate: 500 g dry weight
- No. of organisms per container (treatment): ten
- No. of replicates per treatment group: four
- No. of replicates per control: four

SOURCE AND PROPERTIES OF SUBSTRATE (if soil)
- Geographic location: artificial soil
- Composition (if artificial substrate): 10% dry weight sphagnum peat (pH of 5.5-6.0, no visible plant remains, finely ground and dried), 20% kaolin clay and 70% industrial sand
- Maximum water holding capacity (in % dry weigtht): 35-42

OTHER TEST CONDITIONS
- Photoperiod: continuous
- Light intensity: 400-800 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality

TEST CONCENTRATIONS
- Spacing factor for test concentrations: two

Nominal and measured concentrations:

Nominal: 62.5, 125, 250, 500 and 1000 mg/kg soil dw

Reference substance (positive control):

no

Duration:

14 d

Dose descriptor:

LC0

Effect conc.:

> 1 000 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Key result

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

Duration:

14 d

Dose descriptor:

LC100

Effect conc.:

> 1 000 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Details on results:

No adverse effects were observed in any of the test worms at any concentration.

Validity criteria fulfilled:

yes

Conclusions:

Under the study conditions, the nominal 14 d LC0, LC50 and LC100 of the test substance to the earthworms were determined to be >1000 mg/kg soil dw.

Executive summary:

A study was conducted to determine the toxicity of the test substance to earthworms according to OECD Guideline 207 and EU Method C.8, in compliance with GLP. Forty earthworms per concentration in 500 g artificial soil were exposed to nominal concentrations of 0, 62.5, 125, 250, 500 and 1000 mg/kg soil dw for 14 d. Temperature, pH and moisture were recorded at test start and end. No adverse effects or mortality were observed in any of the test concentrations. Under the study conditions, the nominal 14 d  LC0, LC50 and LC100 of the test substance to the earthworms were determined to be >1000 mg/kg soil dw (Ensenbach, 2001).

Description of key information

The nominal 14 d LC0, LC50 and LC100 of the test substance to the earthworms were determined to be >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 study was conducted to determine the toxicity of the test substance to earthworms according to OECD Guideline 207 and EU Method C.8, in compliance with GLP. Forty earthworms per concentration in 500 g artificial soil were exposed to nominal concentrations of 0, 62.5, 125, 250, 500 and 1000 mg/kg soil dw for 14 d. Temperature, pH and moisture were recorded at test start and end. No adverse effects or mortality were observed in any of the test concentrations. Under the study conditions, the nominal 14 d  LC0, LC50 and LC100 of the test substance to the earthworms were determined to be >1000 mg/kg soil dw (Ensenbach, 2001).