Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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 2011-06-08 to 2011-08-01
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
Batch: E011009938
Analytical monitoring:
yes
Details on sampling:
0; 24, 48, 72, 96 h
Vehicle:
yes
Details on test solutions:
According to guideline
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): TWEEN 80 / SPAN 80 (3/1 v/v)
- 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 Tween 80 / SPAN-80
pos. Control 0.05 mg/L -
pos. Control 0.5 mg/L -
Test item: 33 mg/L 100 mg/L

Vehilce
Control: - 100 mg/L

Negative
Control - -

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
Weight: 0.33 +/- 0.03 g
Length: 3.4 +/- 0.1 cm
Lot: 292-1
Date: 2011-06-08
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
no
Test temperature:
25 +/- 0.1 °C
Nominal and measured concentrations:
33 mg/L
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.:
> 33 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: with vehicle Tween 80 / Span 80 (3/1)
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  20  70  90  100
 Positive Control  0.05  0  0  0  0
 Test item (+vehicle)  33

 0 

 0

 0

 0

 Tween 80 / SPAN-80 (3/1)

 100

 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, solubiliser was used.

Validity criteria fulfilled:
yes
Conclusions:
The LC50 of the test material exceeds 33 mg/L and is clearly above the limit of water solubility.
Executive summary:

The informtion for this endpoint study record was obtained from an experimental study. The OECD GLP criteria were met and the methods applied are fully compliant with OECD TG 203. The LC50 of the test material exceeds 33 mg/L and is clearly above the limit of water solubility.

Description of key information

GLP OECD 203 Assay: LC50 > 33 mg/L, NOEC = 33 mg/L (measured initial) with solubilizer

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
33 mg/L

Additional information

The LC50 of the test material exceeds 33 mg/L and is clearly above the limit of water solubility.