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EC number: 403-530-4 | CAS number: 129423-54-7 PV-ECHTGELB HGR
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
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- Toxicological Summary
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- Acute Toxicity
- Irritation / corrosion
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Toxicity to soil macroorganisms except arthropods
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to soil macroorganisms except arthropods: long-term
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- According to OECD 207 and GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 207 (Earthworm, Acute Toxicity Tests)
- Deviations:
- no
- GLP compliance:
- yes
- Analytical monitoring:
- no
- Details on sampling:
- No analytical monitoring
- Vehicle:
- yes
- Details on preparation and application of test substrate:
- - Method of mixing into soil (if used): The test item was weighed out on quartz sand (5 g/replicate).
- Method of mixing into soil (if used): The weighed test item with quartz sand given to the artificial soil. Demineralised water was added to adjust 60 % of the maximum water capacity of the artifical soil. Thereafter the test medium was mixed with a long handled blender for at least 3 minutes and filled into the test vessels.
- Controls: Artificial soil without test item and 5 g quartz sand was used as control medium. - Test organisms (species):
- Eisenia fetida
- Animal group:
- annelids
- Details on test organisms:
- TEST ORGANISM
- Common name: Eisenia fetida Savigny 1826 (Annelida, Lumbricidae)
- Subspecies: Eisenia fetida andrei
- Source: Bundesanstalt fuer Verbraucherschutz und Landwirtschaft (BVL), Messeweg 11-12, D-38104 Braunschweig
- Age at test initiation (mean and range, SD): adult (with clitellum)
- Weight at test initiation (mean and range, SD): 0.45 - 0.60 g/worm
ACCLIMATION
- Acclimation period: 2 days
- Acclimation conditions (same as test or not):same as test
- Health during acclimation (any mortality observed): No mortality or abnormal behaviour observed - Study type:
- laboratory study
- Substrate type:
- artificial soil
- Limit test:
- yes
- Total exposure duration:
- 14 d
- Test temperature:
- 17-21 °C
- pH:
- pH-values
. day 0 day 14
control 5.76 5.79
1000 mg/kg dw 5.78 5.64 - Moisture:
- Moisture [%] of dry weight
. day 0 day 14
control 48.6 51.6
1000 mg/kg dw 48.2 47.4 - Details on test conditions:
- TEST SYSTEM
- Test container (material, size): Glass dishes (volume 1.5 L), covered with perforated plastic film to prevent the test medium from drying up
- No. of organisms per container (treatment): 10 per container (40 per treatment)
- No. of replicates per treatment group: 4
- No. of replicates per control: 4
- No. of replicates per vehicle control: 4
SOURCE AND PROPERTIES OF SUBSTRATE (if soil)
- Composition (if artificial substrate): 10 % peat, 20 % kaolin, 69 % quartz sand, 0.37 % calcium carbonate
- Organic carbon (%): Not measured
- Maximum water holding capacity (in % dry weigth): 81
- Pretreatment of soil: demineralised water was added to give an overall moisture content of about 30 % of the maximum water holding capacitiy of the soil.
- Storage (condition, duration): room temperature, protected from light, 16 days
OTHER TEST CONDITIONS
- Photoperiod: 16
- Light intensity: 400 - 800 lx
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
The live weight of the earthworms was measured individually at the day of application (day 0) and at day 14.
Mortality, behaviour and morphological changes of the earthworms were recorded 7 and 14 days after application.
Observation parameter
a) no obvious pathological symptoms
b) no reaction to touching
c) no negative phototactical reaction
d) spasmodic winding
e) spontaneous segmentation and separation
f) yellow excretion from the oral aperture
g) ulcer and skin bleedings
t) dead earthworms
VEHICLE CONTROL PERFORMED: Yes
TEST CONCENTRATIONS
- Range finding study: a preliminary non-GLP range finding test was performed with concentrations 1 - 10 - 100 - 1000 mg/kg DW. Now effects were observed during the test duration. Therefore, the definitive study was conducted as limit test with the concentration of 1000 mg/kg DW.
- Nominal and measured concentrations:
- Nominal concentration: 1000 mg/kg soil dw
- Reference substance (positive control):
- yes
- Remarks:
- 2-Chloroacetamide
- Duration:
- 14 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: mortality, loss of body weight, other symptoms
- Details on results:
- - Mortality at end of exposure period: No mortality observed in the control and in the test item concentration
- Morphological abnormalities: No
- Behavioural abnormalities: No
- Other biological observations: No - Results with reference substance (positive control):
- - Results with reference substance valid? Yes
- Relevant effect levels: LC50: 27.8 (CI: 26.4 - 29.2) mg/kg soil DW, NOEC: 15.0 mg/kg soil DW - Reported statistics and error estimates:
- One Way Analysis of Variance (ANOVA) was carried out for the determination of statistically significant effects in comparison with control replicates. A Normality Test and an Equal Equal Variance Test were conducted prior to ANOVA. P-values for both Normality and Equal Variance Test were < 0.05. The α-value for ANOVA (acceptable probability of incorrectly concluding that there is no difference) is α = 0.05.
- Validity criteria fulfilled:
- yes
- Conclusions:
- No mortality as well as no pathological symptoms or changes in the earthworm behaviour were observed at the limit test item concentration of 1000 mg/kg soil dry weight after 14 days of exposure to Pigment Yellow 191. Compared to the control the biomass of earthworms exposed to test item at the limit test item concentration of 1000 mg/kg soil dry weight was not statistically significantly reduced at test end.
Consequently, the No Observed Effect Concentration (NOEC) of the test item with respect to mortality, loss of body weight and other symptoms was determined to be at 1000 mg/kg soil dry weight. - Executive summary:
The acute effects of the test item on the earthworm Eisenia fetida were determined according to the OECD Guideline 207. The study was conducted with a limit test item concentration of 1000 mg/kg soil dry weight throughout 14 days. Artificial soil without test item was used as control. 40 test organisms with an individual weight between 0.45 - 0.6 g, divided into four replicates, were tested at the limit test item concentration and controls in artificial soil containing 10 % peat.
No mortality as well as no pathological symptoms or changes in the earthworm behaviour were observed at the limit test item concentration of 1000 mg/kg soil dry weight after 14 days of exposure. Compared to the pooled control, the biomass of the earthworms at the limit test item concentration of 1000 mg/kg soil dry weight was not statistically significantly reduced at test end.
Consequently, the no observed effect concentration (NOEC) with respect to mortality, loss of biomass and other symptoms was determined to be at 1000 mg/kg soil dry weight.
All validity criteria of the test guideline were fulfilled.
- Endpoint:
- toxicity to soil macroorganisms except arthropods: short-term
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reason / purpose for cross-reference:
- read-across source
- Duration:
- 14 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: mortality, loss of body weight, other symptoms
- Details on results:
- - Mortality at end of exposure period: No mortality observed in the control and in the test item concentration
- Morphological abnormalities: No
- Behavioural abnormalities: No
- Other biological observations: No - Results with reference substance (positive control):
- - Results with reference substance valid? Yes
- Relevant effect levels: LC50: 27.8 (CI: 26.4 - 29.2) mg/kg soil DW, NOEC: 15.0 mg/kg soil DW - Reported statistics and error estimates:
- One Way Analysis of Variance (ANOVA) was carried out for the determination of statistically significant effects in comparison with control replicates. A Normality Test and an Equal Equal Variance Test were conducted prior to ANOVA. P-values for both Normality and Equal Variance Test were < 0.05. The α-value for ANOVA (acceptable probability of incorrectly concluding that there is no difference) is α = 0.05.
- Validity criteria fulfilled:
- yes
- Conclusions:
- No mortality as well as no pathological symptoms or changes in the earthworm behaviour were observed at the limit test item concentration of 1000 mg/kg soil dry weight after 14 days of exposure to Pigment Yellow 191. Compared to the control the biomass of earthworms exposed to test item at the limit test item concentration of 1000 mg/kg soil dry weight was not statistically significantly reduced at test end.
Consequently, the No Observed Effect Concentration (NOEC) of the test item with respect to mortality, loss of body weight and other symptoms was determined to be at 1000 mg/kg soil dry weight. - Executive summary:
The acute effects of the test item on the earthworm Eisenia fetida were determined according to the OECD Guideline 207. The study was conducted with a limit test item concentration of 1000 mg/kg soil dry weight throughout 14 days. Artificial soil without test item was used as control. 40 test organisms with an individual weight between 0.45 - 0.6 g, divided into four replicates, were tested at the limit test item concentration and controls in artificial soil containing 10 % peat.
No mortality as well as no pathological symptoms or changes in the earthworm behaviour were observed at the limit test item concentration of 1000 mg/kg soil dry weight after 14 days of exposure. Compared to the pooled control, the biomass of the earthworms at the limit test item concentration of 1000 mg/kg soil dry weight was not statistically significantly reduced at test end.
Consequently, the no observed effect concentration (NOEC) with respect to mortality, loss of biomass and other symptoms was determined to be at 1000 mg/kg soil dry weight.
All validity criteria of the test guideline were fulfilled.
Referenceopen allclose all
No mortality occurred at the limit test item concentration of 1000 mg/kg soil dry weight as well as in the controls after 14 days of exposure to the test item.
During the test the biomass loss of the earthworms was below 20 % in the controls. After 14 days of exposure the earthworm biomass was not statistically significant different at the limit test item concentration of 1000 mg/kg soil dry weight compared to the pooled control.
Mean loss of body weight
|
mean loss of body weight |
||
nominal concentration [mg/kg DW] |
test start [g/worm] |
test end [g/worm] |
loss of body weight [%] |
control |
0.53 |
0.55 |
- 4 |
1000 |
0.53 |
0.56 |
- 6 |
Mean biomass body weight on day 14 compared to control group, 4 replicates (n = 40)
nominal concentration [mg/kg DW] |
mean living weight [g] replicate |
|
|
|
|||
|
1 |
2 |
3 |
4 |
MV ± SD |
coefficient of variation |
statistically significant |
control |
0.56 |
0.51 |
0.57 |
0.54 |
0.55 ± 0.06 |
11 |
- |
1000 |
0.54 |
0.58 |
0.57 |
0.57 |
0.56 ± 0.05 |
9 |
no |
No mortality occurred at the limit test item concentration of 1000 mg/kg soil dry weight as well as in the controls after 14 days of exposure to the test item.
During the test the biomass loss of the earthworms was below 20 % in the controls. After 14 days of exposure the earthworm biomass was not statistically significant different at the limit test item concentration of 1000 mg/kg soil dry weight compared to the pooled control.
Mean loss of body weight
|
mean loss of body weight |
||
nominal concentration [mg/kg DW] |
test start [g/worm] |
test end [g/worm] |
loss of body weight [%] |
control |
0.53 |
0.55 |
- 4 |
1000 |
0.53 |
0.56 |
- 6 |
Mean biomass body weight on day 14 compared to control group, 4 replicates (n = 40)
nominal concentration [mg/kg DW] |
mean living weight [g] replicate |
|
|
|
|||
|
1 |
2 |
3 |
4 |
MV ± SD |
coefficient of variation |
statistically significant |
control |
0.56 |
0.51 |
0.57 |
0.54 |
0.55 ± 0.06 |
11 |
- |
1000 |
0.54 |
0.58 |
0.57 |
0.57 |
0.56 ± 0.05 |
9 |
no |
Description of key information
The acute effects of the test item on the earthworm Eisenia fetida were determined according to the OECD Guideline 207. The study was conducted with a limit test item concentration of 1000 mg/kg soil dry weight throughout 14 days.
No mortality as well as no noteworthy pathological symptoms or changes in the earthworm behaviour were observed at the limit test item concentrationof 1000 mg/kg soil dry weight after 14 days of exposure. Compared to the pooled control, the biomass of the earthworms at the limit test item concentration of 1000 mg/kg soil dry weight was not statistically significantly reducedat test end.
Consequently, the no observed effect concentration (NOEC) with respect to mortality, loss of biomass and other symptoms was determined to be at 1000 mg/kg soil dry weight.
Key value for chemical safety assessment
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