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EC number: 433-180-8 | CAS number: -
Short-term toxicity to fish
Administrative data
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999-04-12 to 16.04.1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline Study ( Council Directive 92/69/EEC C.1 (1992))
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Details on test material:
- -Name of test material (as cited in study report): Reaktiv-Orange DYPR934
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- Test procedure: test vessels (300x135x200mm), 5l medium, ventilated, static
Method of administration direct weighing according to (SOP 2030-6600401-96-D)
Test concentration (mg/L) 100
No solubilizer or other auxiliaries
Test solutions
- Vehicle:
- no
- Details on test solutions:
- A limit test was performed at 100 mg (active ingredient)/l in order to demonstrate that the LC50 is greater than this concentration.
Control: synthetic fresh water in accordance with ISO
Water for dilution: synthetic fresh water in accordance with ISO, dH 13.6°
Test organisms
- Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- Zebra fish (Brachydanio rerio HAMILTON BUCHANAN); from the Bio International B.V. (Netherlands)
Body length: 2.5 – 3.5 cm; age: 12 weeks (birth 11.11.1998, supplied 04.02.1999)
Keeping conditions: according to SOP 2030-7700103-98 D
Mortality while kept: <2%
Medical pretreatment: none
Keeping water: Synthetic fresh water in accordance with ISO.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Post exposure observation period:
- Duration 5 days (1999-04-12 to 1999-04-16), daily analysis of the only test concentration plus a control
Test conditions
- Hardness:
- 13.6 mg CaCO3/L
- Test temperature:
- 20.9-21.9
- pH:
- 7.7-8.0
- Dissolved oxygen:
- ca. 8.4 mg/L
- Nominal and measured concentrations:
- 100 mg/L
- Details on test conditions:
- DETAILS ON TEST CONDITIONS
STUDY CONDITIONS (SOP 2030-7000103-98 D)
OPERATING CONDITIONS Static test in accordance with above mentioned method
PHOTOPERIOD 16 hours light/8 hours dark
TEST PROCEDURE -Test vessels (300x135x200mm)
-5 L medium
-ventilated
-static
METHOD OF ADMINISTRATION Direct weighing (SOP 2030-6600401-96 D)
TEST CONCENTRATION/S [mg/mL] 100
SOLUBILIZER OR OTHER AUXILIARIES none
CONTROL Synthetic fresh water in accordance with ISO.
WATER FOR DILUTION Synthetic fresh water in accordance with ISO
WATER HARDNESS [°dH] 13.6
Results and discussion
Effect concentrationsopen allclose all
- Dose descriptor:
- LC0
- Effect conc.:
- >= 64.4 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- other: (organic components)
- Dose descriptor:
- LC0
- Effect conc.:
- >= 94.7 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- other: (test substance; including inorganic components)
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Details on results:
- Observations: No abnormal appearance and behavior, visible effects: normal swimming action,
Mortality = 0
Any other information on results incl. tables
- Sublethal observations / clinical signs:
RESULTS-ANALYSIS
Nominal concentration test substance
[mg/L]
Analytical dates [mg/L]
0 h
24 h
48 h
72 h
96 h
control
<2
<2
<2
<2
<2
100
22
23
24
24
24
Comments: All values refer to TOC determinations. According to the relevant product informations 1mg/L TOC equals 2.75 mg/L of the organic components of the test substance.
VISIBLE EFFECTS ON APPEARANCE AND BEHAVIOUR OF FISH
(SOP 2030-7000103-98 D)
Concentration of the test substance
Control
After 2 hours
10 animals normal swimming action
After 2 hours
10 animals normal swimming action
After 24 hours
10 animals normal swimming action
After 48 hours
10 animals normal swimming action
After 72 hours
10 animals normal swimming action
After 96 hours
10 animals normal swimming action
Concentration of the test substance
100 mg/L
After 2 hours
10 animals normal swimming action
After 2 hours
10 animals normal swimming action
After 24 hours
10 animals normal swimming action
After 48 hours
10 animals normal swimming action
After 72 hours
10 animals normal swimming action
After 96 hours
10 animals normal swimming action
TOTAL WEIGHT (FRESH WEIGHT) AND BODY LENGTH OF TEST FISH AT DEATH/AFTER SACRIFICING AT END OF STUDY)
Test fish
Body length [cm] at various test concentrations [mg/L]
1
Control
100
2.7
3.0
2
2.7
2.5
3
3.0
3.5
4
3.0
3.0
5
2.8
3.2
6
2.7
3.0
7
2.9
3.3
8
2.7
3.1
9
2.7
3.2
10
3.2
2.6
Fresh weight [g]
Of 10 fishes
1.86
2.38
Other measurements:
LC50: no dead fish, no dose-response relationships out of the study
TOC determination
Abiotic parametersTime (h)
Temperature(°C)
Oxygen (mg/L)
Oxygen Saturation (%)
pH value
0
21.9
8.7
101.8
8.0
24
21.1
8.2
94.6
7.7
48
21.0
8.5
97.9
7.7
72
20.9
8.3
95.4
7.7
96
20.9
8.4
96.5
7.8
Mortality: 0 over all periods of time (Absolute, cumulative)
10 fishes Concentration 100mg/L
Time (h)
Temperature(°C)
Oxygen (mg/L)
Oxygen Saturation (%)
pH value
0
21.9
8.8
102.9
7.8
24
21.1
8.4
96.6
7.8
48
21.0
8.6
99.1
7.7
72
20.9
8.4
96.6
7.8
96
20.9
8.6
98.9
7.8
Mortality: 0 over all periods of time (Absolute, cumulative)
TOTAL WEIGHT ( FRESH WEIGHT) AND BODY LENGTH OF THE TEST FISH AT DEATH/AFTER SACRIFICING AT END OF STUDY
Test fish
Body length [cm] at various test concentrations [mg/L]
Control
100
1
2.7
3.0
2
2.7
2.5
3
3.0
3.5
4
2.8
3.0
5
2.8
3.2
6
2.7
3.0
7
2.9
3.3
8
2.7
3.1
9
2.7
3.2
10
3.2
2.6
Fresh weight [g] of 10 fishes
1.86
2.38
NOEC: 64.4 mg/L
Maximum test concentration causing no mortality: 100 mg/L(nominal).
Minimum test concentration causing 100% mortality: NA
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- Results:
LC 0 >= 64.4 mg/L (organic components)
LC 0 >= 94.7 mg/L (test substance, including inorganic components)
Controls: Mortality = 0
Observations: No abnormal appearance and behavior, visible effects: normal swimming action,
Mortality = 0 - Executive summary:
In a 96h acute fish toxicity 100 mg/L of Reaktiv-Orange DYPR 934 was tested to 10 Zebra fish (Brachydanio rerio; HAMILTON BUCHMAN).
The LC0 and the LC100 were determined directly from the study, while the LC50 was calculated or read from the dose-response curve.
Following results were obtained:
LC0 >= 64.4 mg/l (organic components)
LC0 >= 94.7 mg/l (test substance, including inorganic components)
Controls: Mortality = 0
Observations: No abnormal appearance and behavior, visible effects: normal swimming action,
Mortality = 0
The absence of mortality indicates that the fish is not the most sensitive test species and that, with at least 99 % of
confidence, the LC50 is greater than the threshold concentration.
LC50 at 96 h > 100 mg/L (Brachydanio rerio)
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