Registration Dossier

Diss Factsheets

Ecotoxicological information

Short-term toxicity to fish

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 2004-04-28 to 2004-06-11
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
Principles of method if other than guideline:
This study was performed as a pre test for bioaccumulation. It was done according to GLP and the methods applied are fully compliant with OECD TG 203. Solvent was used to increase the exposure.
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
Collected after 0, 24, 48, 72 and 96 h.
Vehicle:
yes
Details on test solutions:
According to guideline
PREPARATION AND APPLICATION OF TEST SOLUTION
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): SPAN 60
- Concentration of vehicle in test medium (stock solution and final test solution(s) at different concentrations and in control(s)):

- Nominal values

Substance Concentration Solubilizer SPAN-60
pos. Control 0.5 mg/L 500 mg/L
Test item: 100 mg/L 500 mg/L
Test item: 50 mg/L 500 mg/L
Test item: 25 mg/L 500 mg/L
Test item: 12.5 mg/L 500 mg/L
Test item: 6.25 mg/L 500 mg/L

- Analytical values

Substance Concentration Solubilizer SPAN-60
pos. Control 0.5 mg/L 500 mg/L
Test item: 99.4 mg/L 500 mg/L
Test item: 46.9 mg/L 500 mg/L
Test item: 25.9 mg/L 500 mg/L
Test item: 12.6 mg/L 500 mg/L
Test item: 6.55 mg/L 500 mg/L
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
Weight: 0.21 +/- 0.01 g
Length: 2.9 +/- 0.1 cm
Lot: 40315
Date: 2004-03-15
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
no
Test temperature:
24.3 +/- 0.1 °C
Nominal and measured concentrations:
see "Details on test solutions"
Details on test conditions:
10 fish per 4 L
Reference substance (positive control):
not specified
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 99.4 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Sublethal observations / clinical signs:

- Mortality of control: 0 % after 96 hours

Mortality in %

 Sample              Mortality / [%]
 Test Material  Concentration / [mg/L]  24 h  48 h  72 h 96 h
 Positive Control  0.5  0  20  40  90
 Positive Control  0.05  0  0  0  0
Test item  99.4

 0 

 0

 0

 0

Test item

 49.9

 0

 0

 0

 0

Test item

 25.9

 0

 0

 0

 0

Test item

 12.6

 0

 0

 0

 0

 Test item

 6.55

 0

 0

 0

 0

SPAN-60

 500

 0

 0

 0

 0

 Blank

 0

 0

 0

 0

 0

All concentrations tested were at or above the solubility limit of the pure test substance. To achive the exposure concentrations, solvent SPAN 60 was used.

Validity criteria fulfilled:
yes
Conclusions:
In the study SPAN 60 (500 mg/L) was used to ensure a maximum exposure at or above the water solubility limit of the test item. No mortality was observed up to the highest concentration tested. A LC50 > 99.4 mg/L (meas. initial) was determined and is considered to correspond to a nominal concentration of 100 mg/L.
Executive summary:

Study Design


The acute toxicity of the test material was studied in a pretest for a bioaccumulation study (OECD TG 305) using solvents to increase exposure. The GLP test was performed according to the METI Guideline: Concentration Test on Chemical Substances in Fish.


To achive the exposure concentrations, solvent SPAN 60 (500 mg/L) was used. All concentrations tested were at or above the solubility limit of the pure test substance. For the test Brachydanio rerio (new name: Danio rerio) was used.


 


Results


At a test material concentration of 99.4 mg/L adjusted with SPAN 60 as solubilzer no mortality was observed after 24, 48, 72 and 96 hours, respectively.


The test material does not possess acute toxic potential to fish up to the limit of solubility in water. The 96 hours LC50 exceeds the water solubility limit of the pure substance.


 


Conclusion


In the study SPAN 60 (500 mg/L) was used to ensure a maximum exposure at or above the water solubility limit of the test item. No mortality was observed up to the highest concentration tested. A LC50 > 99.4 mg/L (meas. initial) was determined and is considered to correspond to a nominal concentration of 100 mg/L.

Description of key information

In the study SPAN 60 (500 mg/L) was used to ensure a maximum exposure at or above the water solubility limit of the test item. No mortality was observed up to the highest concentration tested. A LC50 > 99.4 mg/L (meas. initial) was determined and is considered to correspond to a nominal concentration of 100 mg/L.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Dose descriptor:
LC50
Effect concentration:
> 100 mg/L

Additional information

Study Design


The acute toxicity of the test material was studied in a pretest for a bioaccumulation study (OECD TG 305) using solvents to increase exposure. The GLP test was performed according to the METI Guideline: Concentration Test on Chemical Substances in Fish.


To achive the exposure concentrations, solvent SPAN 60 (500 mg/L) was used. All concentrations tested were at or above the solubility limit of the pure test substance. For the test Brachydanio rerio (new name: Danio rerio) was used.


 


Results


At a test material concentration of 99.4 mg/L adjusted with SPAN 60 as solubilzer no mortality was observed after 24, 48, 72 and 96 hours, respectively.


The test material does not possess acute toxic potential to fish up to the limit of solubility in water. The 96 hours LC50 exceeds the water solubility limit of the pure substance.


 


Conclusion


In the study SPAN 60 (500 mg/L) was used to ensure a maximum exposure at or above the water solubility limit of the test item. No mortality was observed up to the highest concentration tested. A LC50 > 99.4 mg/L (meas. initial) was determined and is considered to correspond to a nominal concentration of 100 mg/L.