Registration Dossier
Registration Dossier
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EC number: 204-388-4 | CAS number: 120-35-4
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:
- 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according to OECD Guideline No. 203
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Version / remarks:
- 84/449/EEC
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-amino-4-methoxybenzanilide
- EC Number:
- 204-388-4
- EC Name:
- 3-amino-4-methoxybenzanilide
- Cas Number:
- 120-35-4
- Molecular formula:
- C14H14N2O2
- IUPAC Name:
- 3-amino-4-methoxy-N-phenylbenzamide
Constituent 1
Sampling and analysis
- Analytical monitoring:
- no
Test solutions
- Details on test solutions:
- PREPARATION OF TEST SOLUTION
The test item was diluted with water. After homogenizitation by ultrasound and intensive stirring the mixture was incorporated into the test vessel and stirred for another 2 hours. At all concentration levels precipitate were observed.
Test organisms
- Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: zebrafish
- Strain: Brachydanio rerio (Hamilton-Buchanan)
- Source: West Aquarium, D-37431 Bad Lauterberg, Germany
- Age at study initiation: ca. 3 months
- Length at study initiation (mean (n=60), range and SD): 3.0 cm, 2,5 - 3.5 cm, SD 0.27
- Feeding during test: No feeding during the test
ACCLIMATION
- Acclimation period: at least 14 days
- Type and amount of food: Tetra Min, ad libitum
- Feeding frequency: 2 times per day
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1°C
- Photoperiod (hrs dark / hrs light): 12/12
- The dissolved oxygen concentration was more than 80 % of the air saturation value
Study design
- Test type:
- static
- Water media type:
- freshwater
- Total exposure duration:
- 96 h
- Post exposure observation period:
- Observations were carried out during exposure at the beginning of the experiment and after 2 - 4, 24, 48, 72 and 96 hours. Observation of symptoms was restricted by white turbidity due to low solubillity of the test substance.
Test conditions
- Test temperature:
- 21.0°C - 21.9°C (treatment), 21.1°C - 23.0°C (control)
- pH:
- 6.7 - 8.2 (treatment), 7.4 - 8.4 (control)
- Dissolved oxygen:
- 6.3 - 9,3 mg/L (treatment); 6.7 - 9.6 mg/L (control)
- Nominal and measured concentrations:
- Nominal concentrations: 1 000, 2 500, 3 500, 5 000, 7 100 and 10 000 mg/L.
- Details on test conditions:
- TEST SYSTEM
- Test vessel: Glass-aquaria 30 cm x 22 cm x 24 cm, 10 L per vessel
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: fish density in the tanks was less than 1 g per litre test solution.
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water, quality according ISO 7346/1. The water was saturated with oxygen. pH-value: 7.9 - 8.0.
pH , temperature and oxygen saturation were observed at the beginning, after 2-4, 24, 48, 72 and 96 h in all vessels
OTHER TEST CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12
- Light intensity: 700 Lux
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Mortality and behavior of the test fish and control fish were observed at 2-4, 24, 48, 72, 96 h.
- Reference substance (positive control):
- no
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 96 h
- Dose descriptor:
- LC0
- Effect conc.:
- >= 1 000 mg/L
- Nominal / measured:
- nominal
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 10 000 mg/L
- Nominal / measured:
- nominal
- Basis for effect:
- mortality (fish)
- Details on results:
- - There was no mortality in control at any observation time point.
- At concentrations 2 500 - 10 000 mortalities were observed after 24 h.
- Behavioural abnormalities at all concentration levels: swimming posture tail- and head-heavy, upside-down and on side; increased and decreased activity; increased and decreased fright reaction; swimming and sitting at the survace and on the base of the tank; projecting opercula; convulsions, twitching,
Any other information on results incl. tables
- Sublethal observations / clinical signs:
Table 1: test concentrations and results
Concentration
Mortality
[mg/L]
2 - 4 h
24 h
48 h
72 h
96 h
0
0 / 10
0 / 10
0 / 10
0 / 10
0 / 10
10 000
0 / 10
2 / 10
3 / 10
3 / 10
3 / 10
0
0 / 10
0 / 10
0 / 10
0 / 10
0 / 10
7 100
0 / 10
1 / 10
2 / 10
2 / 10
2 / 10
0
0 / 10
0 / 10
0 / 10
0 / 10
0 / 10
5 000
0 / 10
2 / 10
2 / 10
2 / 10
2 / 10
0
0 / 10
0 / 10
0 / 10
0 / 10
0 / 10
3 500
0 / 10
0 / 10
1 / 10
2 / 10
2 / 10
0
0 / 10
0 / 10
0 / 10
0 / 10
0 / 10
2 500
0 / 10
0 / 10
1 / 10
1 / 10
1 / 10
0
0 / 10
0 / 10
0 / 10
0 / 10
0 / 10
1 000
0 / 10
0 / 10
0 / 10
0 / 10
0 / 10
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- 67/548/EEC: Acute aquatic toxicity: no classification warranted
1272/2008/EC: Acute aquatic toxicity: no classification warranted - Executive summary:
The acute toxicity of the test item to fish (zebrafish) was determined according to OECD-Guideline for Testing of Chemicals No. 203 (1984) at Hoechst AG, Frankfurt, Germany. Static test with the concentrations 1 000, 2 500, 3 500, 5 000, 7 100 and 10 000 mg/L solution were conducted. The preparation method has been chosen with regard to the test item properties and in accordance with the relevant OECD guidance document. Duration of the test was 96 h. 10 test organisms were exposed to the test solution and the control respectively. Water quality parameters pH-value, temperature and oxygen-saturation measured after 0, 2 -4, 24, 48, 72 and 96 h were determined to be within the acceptable limits.
There were no mortalities at a concentration of 1 000 mg/L at any observation time point. At all other concentration levels up to 30 % mortalities were observed after 24 h to 72 h.
At all test concentration levels the following signs of toxicity were observed: swimming posture tail- and head-heavy, upside-down and on side; increased and decreased activity; increased and decreased fright reaction; swimming and sitting at the survace and on the base of the tank; projecting opercula; convulsions, twitching.
The median lethal concentration of the test item to zebrafish observed is:
LC50 (96 h): greater than 10 000mg/L
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