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Diss Factsheets

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991
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:
1991
Report date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
yes
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Version / remarks:
84/449/EEC
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-hydroxy-2'-methoxy-2-naphthanilide
EC Number:
205-206-6
EC Name:
3-hydroxy-2'-methoxy-2-naphthanilide
Cas Number:
135-62-6
Molecular formula:
C18H15NO3
IUPAC Name:
3-hydroxy-N-(2-methoxyphenyl)naphthalene-2-carboxamide

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
For each concentration, two 20 mL samples were taken from the vessel centre after 0 and 24 h .

Test solutions

Details on test solutions:
PREPARATION OF TEST SOLUTION
The test item was suspended with 0.095 mL Tween 80/L as solvent and 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 concentration levels >/= 2.2 mg/L 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: Hoechst, breeding colony
- Age at study initiation: ca. 3 months
- Length at study initiation (mean (n=20), range and SD): 3.0 cm, 2,6 - 3.4 cm, SD 0.22
- Feeding during test: no

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:
semi-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.

Test conditions

Test temperature:
22.3°C - 23.0°C (treatment), 22.0°C - 22.8°C (control)
pH:
7.8 - 8.5 (treatment), 7.8 - 8.5 (control)
Dissolved oxygen:
5.4 - 8,8 mg/L (treatment); 5.9 - 9.6 mg/L (control)
Nominal and measured concentrations:
Nominal concentrations: 1, 2.2 and 5 mg/L.
Measured concentrations: 56 - 97 % of the nominal concentrations after 0 h; 31 - 66 % of the nominal concentrations after 24 h.
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: 8.2 - 8.6.
pH , temperature and oxygen saturation were observed at the beginning, after 2-4, 24, 48, 72 and 96 h in all vessels
- Renewal rate of test solution (frequency/flow rate): every 24 h


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 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
2.2 - 5 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
5 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
0.6 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
1.4 - 2.7 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
2.7
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
- There was no mortality in control at any observation time point.
- At concentration 2.2 mg/L mortalities were observed after 96 h, at 5 mg/L after 48 h.
- Behavioural, swimming posture and respiration abnormalities were observed at all concentration levels. Died fishes showed dark or light discoloured and shiny metallic integument and reddened gills.

Any other information on results incl. tables

Sublethal observations / clinical signs:

Table 1: test concentrations and results

Concentration [mg/L]

Mortality

 

48 h

96 h

0

0 /20

0 /20

0.095 mL Tween 80 /L

0 /10

0 /10

1

0 /10

0 / 10

2.2

0 / 10

2 / 10

5

6 / 10

10 / 10

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
67/548/EEC: N, R 51/53
1272/2008/EC: Aquatic chronic category 2, H411

log pow = 4.88, see chapter 4.7; not readily biodegradable see chapter 5.2.1
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. Semi-static test with the concentrations 1, 2.2 and 5 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 controls 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 mg/L at any observation time point. At all other concentration levels up to 100 % mortalities were observed after 96 h.

At all test concentration levels the following signs of toxicity were observed: behavioural, swimming posture and respiration abnormalities.

The median lethal concentration of the test item to zebrafish observed is:

LC50 (96 h): 2.2 - 5 mg/L (nominal); 1.4 -2.7 mg/L (measured)