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Ecotoxicological information

Short-term toxicity to fish

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Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1996-11-11 to 1997-01-15
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
yes
Remarks:
pH, oxygen and hardness of the test water missing
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
- Concentrations: nominal
- Sampling method:
- Sample storage conditions before analysis:
- Concentrations: The test substance was weighed, directly mixed into the test system and stirred for 24 hours using an ultraturrax. Afterwards, the test water was clear without oily drops on the water surface (main test 1) or with oily drops on the water surface (maintest 2). In main test 2, approximatly one liter of the test system including the oily drops were removed afterv 3.5 hours, treated by an ultraturrax and transferred back to the test system. Accordingl, the study duration was adapted, i.e. study start was postponed by 3.5 hours.
- Sampling method: from the test water
- Sample storage conditions before analysis: not reported
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: directly weighing ino the test systenms and stirring for 24 hours
- Eluate: not applicable
- Differential loading: not applicable
- Controls: water control
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): no vehicle used
- Evidence of undissolved material (e.g. precipitate, surface film, etc): no (see above)
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: zebra fish
- Strain: not applicable
- Source: Charles River Aquatics (delivery from 1996-08-06)
- Age at study initiation (mean and range, SD): not reported
- Length at study initiation (length definition, mean, range and SD): not reported
- Weight at study initiation (mean and range, SD): not reported
- Method of breeding: not applicable
- Feeding during test: no

ACCLIMATION
- Acclimation period: not reported
- Acclimation conditions (same as test or not): not reported
- Type and amount of food: SSNIFF M (Charge: 9556413)
- Feeding frequency: not reported
- Health during acclimation: mortality < 5 % during the last wekk before test start
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
not reported
Test temperature:
20.4-21.8 °C
pH:
8.2-8.6
Dissolved oxygen:
minimum: 75 %
Salinity:
not applicable
Nominal and measured concentrations:
nominal 2.0, 4.0, 8.0 and 13 mg/L
mean measured for nominal 2.0 mg/L (0-24 h): 64.0 %
mean measured for nominal 4.0 mg/L (0-24 h): 69.8 %
mean measured for nominal 8.0 mg/L (0-24 h): 62.3 %
mean of mean measured: 65.4 %
resulting mean measured test concentrations: 1.3, 2.6, 5.2 and 8.5 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: 10 L
- Type: open
- Material, size, headspace, fill volume: not reported, 5 L, 5 L
- Aeration: not reported
- Renewal rate of test solution: semistatic (24 hours renewal):
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: not reported

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: drinking water
- Total organic carbon: not reported
- Particulate matter: not reported
- Metals: free of copper
- Pesticides: not reported
- Chlorine: free of chlorine
- Alkalinity: not reported
- Ca/mg ratio: not reported
- Conductivity: not reported
- Culture medium different from test medium: no
- Intervals of water quality measurement: not reported

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light, 8 h dark
- Light intensity: not reported

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): mortality, imbalance, apathy

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.625 to 2
- Range finding study: main test 1 cited but no results presented (with the exception of observations after application)
Reference substance (positive control):
no
Duration:
0 h
Dose descriptor:
LC0
Effect conc.:
13 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
0 h
Dose descriptor:
NOEC
Effect conc.:
8 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
behaviour
Duration:
0 h
Dose descriptor:
LOEC
Effect conc.:
13 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
behaviour
Duration:
4 h
Dose descriptor:
LC0
Effect conc.:
8 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
4 h
Dose descriptor:
LC100
Effect conc.:
13 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
4 h
Dose descriptor:
NOEC
Effect conc.:
4 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
behaviour
Duration:
4 h
Dose descriptor:
LOEC
Effect conc.:
8 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
behaviour
Duration:
24 h
Dose descriptor:
LC0
Effect conc.:
5.2 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
24 h
Dose descriptor:
NOEC
Effect conc.:
2.6 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
behaviour
Duration:
24 h
Dose descriptor:
LOEC
Effect conc.:
5.2 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
behaviour
Duration:
48 h
Dose descriptor:
LC0
Effect conc.:
5.2 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
1.3 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
behaviour
Duration:
48 h
Dose descriptor:
LOEC
Effect conc.:
2.6 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
behaviour
Duration:
72 h
Dose descriptor:
LC0
Effect conc.:
2.6 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
72 h
Dose descriptor:
NOEC
Effect conc.:
1.3 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
behaviour
Duration:
72 h
Dose descriptor:
LOEC
Effect conc.:
2.6 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
behaviour
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
2.6 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
6.3 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
1.3 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
behaviour
Duration:
96 h
Dose descriptor:
LOEC
Effect conc.:
2.6 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
behaviour

Table 1 Analytics

 Nominal test concnetration (mg/L)  measured at 0 h (mg/L)  measured at 24 h (mg/L  % from nominal at 0 h  % from nominal at 24 h mean % from nominal 0 -24 h 
   ---  0.70 ---   35.0  
 2.0  1.96  0.92  98.0  46.0  64.0
   1.58  0.75  79.0  370.5  
   ---  2.01  ---  50.3  
 4.0  4.16  2.43  104.0  60.8  69.8
   2.96  1.63  74.0  40.8  
   ---  3.67  ---  45.9  
 8.0  7.33  4.57  91.6  57.1  62.3
   5.05  3.10  63.1  38.8  

Tabe 2 Mortality and symptoms of toxicity (main test 2)

 Conc.  Exposure time (h)               
 (mg/L)  0 2 -4 24  48  72  96
 0  0  0  0  0  0
 2.0  0  0  0  0  0  0
 4.0  0  0  0  0 A  0 A  0 A
 8.0  0  0 GA  0 GA  0 GA  10 GA  20 GA
 13  0 GA  100  100  100  100  100

G: imbalancies

A: apathy

Validity criteria fulfilled:
yes
Conclusions:
In a valid, reliable and conclusive study according to EU method C1 (1992), the test substance Sandalice resulted to the following values for acute fish toxicity after 96 hours of exposure: LC0 = 2.6 mg/L (mean measured), LC50 = 6.3 mg/L (mean measured), LC100 = 8.5 mg/L (mean measured).
Executive summary:

The acute toxicity of the test substance Sandelice on zebra fish was determined according to EU method C1 (1992). The following nominal test concnetrations were used: 2.0, 4.0, 8.0 and 13 mg/L. The test organisms were exposed to the test substance for 96 hours in a semi-static test design with a daily renewal of the treated test water. The LC50 was calculated using semi-logarithmic interpolation including LC100. Since the analytical recovery of the test concentration after 24 hours decreased below 80 % of nominal, the mean measured test concentration was calculated by using all recovery values (%). The following LC-values were determined:

LC0 = 2.6 mg/L

LC50 = 6.3 mg/L

LC100 = 8.5 mg/L

Description of key information

The acute toxicity of the test substance Sandelice on zebra fish was determined according to EU method C1 (1992). The following nominal test concentrations were used: 2.0, 4.0, 8.0 and 13 mg/L. The test organisms were exposed to the test substance for 96 hours in a semi-static test design with a daily renewal of the treated test water. The LC50 was calculated using semi-logarithmic interpolation including LC100. Since the analytical recovery of the test concentration after 24 hours decreased below 80 % of nominal, the mean measured test concentration was calculated by using all recovery values (%).

The following LC-values were determined:

LC0 = 2.6 mg/L

LC50 = 6.3 mg/L

LC100 = 8.5 mg/L

Key value for chemical safety assessment

LC50 for freshwater fish:
6.3 mg/L

Additional information