Registration Dossier

Ecotoxicological information

Toxicity to soil macroorganisms except arthropods

Administrative data

Endpoint:
toxicity to soil macroorganisms except arthropods: short-term
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 207 (Earthworm, Acute Toxicity Tests)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test substance: Basic Yellow 8511
- Chemical name: Bis (2,2"-(2-(N,N-Dimethylamino)ethyloxycarbonyl)phenylazo) -1,3-dihydroxybenzol, bishydrochlori d
- Purity: 98,9 area-% (HPLC wave length 215nm); 99,1 area% (HPLC wave length 420nm)
- Lot/batch No.: Vers. ZD 00969/086

Sampling and analysis

Analytical monitoring:
no

Test substrate

Vehicle:
no

Test organisms

Test organisms (species):
Eisenia fetida
Animal group:
annelids
Details on test organisms:
TEST ORGANISM
- Common name: redworms
- Source: Mrs Haber, 64367 Mühltal-Frankenhausen Germany
- Age at test initiation: 7 month
- Weight at test initiation: about 300-600 mg

ACCLIMATION
- Acclimation period: 24 h before the test
- Acclimation conditions: same as test

Study design

Study type:
laboratory study
Substrate type:
artificial soil
Limit test:
no
Total exposure duration:
14 d

Test conditions

Test temperature:
18-22°C
pH:
6.3
Moisture:
water content of dry weight: 33%
Details on test conditions:
TEST SYSTEM
- Test container: 1L glass vessels
- Amount of soil or substrate: 750 g artificial soil (moist weight)
- No. of organisms per container: 10
- No. of replicates per treatment group: 4
- No. of replicates per control: 4

SOURCE AND PROPERTIES OF SUBSTRATE (if soil)
- Soil texture
- 69.7 % quartz sand (Fa. Gebr. Willersinn)
- 20.0 % kaolin clay (Fa. Ziegler & Co., Wunsiedel)
- 10.0 % sphagnum peat (Hornbach Oggersheim)
- 0.3 % CaCO3 (Fa. Merck)
- The water content of the test substrate before adding liquid (1.24 %) was determined by drying a part of the test substrate at 105°C (24h) and following reweighing.

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

EFFECT PARAMETERS MEASURED (with observation intervals) : surviving after 7 and 14 days and weight after 0 and 14 days
Nominal and measured concentrations:
The test substance was tested in the range of concentrations between 1000 and 0,1 mg/kg .
The dilution factor was 10 .
Reference substance (positive control):
yes
Remarks:
chloracetamide

Results and discussion

Effect concentrationsopen allclose all
Duration:
14 d
Dose descriptor:
NOEC
Effect conc.:
> 1 000 other: mg/Kg
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
14 d
Dose descriptor:
LC0
Effect conc.:
> 1 000 other: mg/kg
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
14 d
Dose descriptor:
LC50
Effect conc.:
> 1 000 other: mg/kg
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
14 d
Dose descriptor:
LC100
Effect conc.:
> 1 000 other: mg/kg
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Results with reference substance (positive control):
- Result with reference substance was valid: 14 d LC50 of the control substance chloracetamide was 30.9 mg/kg

Any other information on results incl. tables

No negative impact on worm biomass was detected. No other
particular behavioural or morphological changes were
observed.

Applicant's summary and conclusion