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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 0, 100 mg/l, sampled before test started & after the end of the 24h exposure period
- Sampling method: Not reported, but sampled every 24h when test solutions changed
- Sample storage conditions before analysis: No data
Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: 0.3 wt % of the liquid Tris(2-ethylhexyl)benzene-1,2,4-tricarboxylate ( with solubilizer hydrogenated castor oil HCO-40 3000mg/L) was pipetted or poured into (0.3 wt % with solubilizer hydrogenated castor oil HCO-40 3000 mg/L) into the test waters.
- Eluate: dechlorinated (passed through activated charcoal) tap water
- Differential loading: No data
- Controls: control & dispersant control
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): hydrogenated castor oil HCO-40
- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s)): 3000 mg/L
- Evidence of undissolved material (e.g. precipitate, surface film, etc): No, not reported, but cloudy appearance at high concentration
Test organisms (species):
Oryzias latipes
Details on test organisms:
TEST ORGANISM
- Common name: Oryzias latipes
- Strain: Oryzias latipes
- Source: Medaka commercial breeder
- Length at study initiation (length definition, mean, range and SD): 22.1 mm (18.3-23.8 mm)
- Weight at study initiation (mean and range, SD):mean(n=10) : 0.1462 g
- Feeding during test: No

ACCLIMATION
- Acclimation period: 12d
- Health during acclimation (any mortality observed): Not reported, any group with no mortality in last 7 days selected as suitable for test
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
No
Hardness:
25 mg/ml, as CaCO3
Test temperature:
23.5-24.1 °C
pH:
6.7-6.8
Dissolved oxygen:
5.0-9.2 mg/l
Salinity:
N/A fresh water
Nominal and measured concentrations:
nominal concentrations: 0, 100 mg/L
measured concentrations at 0h:<1, 103 mg/L respectively
measured concentrations at 24h: <1, 102 mg/L respectively
Details on test conditions:
TEST SYSTEM
- Test vessel: glass beaker
- Material, size, headspace, fill volume: 3L
- Aeration: No, without aeration under room light
- Type of flow-through (e.g. peristaltic or proportional diluter): Not applicable
- Renewal rate of test solution (frequency/flow rate): 24h
- No. of organisms per vessel: 10 fish of one group
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): 1
- Biomass loading rate: ca. 0.5 g/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Tap water after dechlorinated by passing through activated charcoal
- Intervals of water quality measurement: 24h

OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: throughout 96h
- Light intensity: room light

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

TEST CONCENTRATIONS
- Spacing factor for test concentrations: N/A limit test
- Justification for using less concentrations than requested by guideline: N/A
- Range finding study No data
Reference substance (positive control):
yes
Remarks:
Copper (II) sulphate pentahydrate
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: N/A
Details on results:
- Behavioural abnormalities: At 24 hr, one fish exposed at 100 mg/L showed abnormal breathing behaviour.

- Mortality of control: 1 fish was found dead at 96h.
- Other adverse effects control: No
- Abnormal responses: None other than above
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: Test solution became cloudy at 100mg/L concentration, but no precipitation. occurred
- Effect concentrations exceeding solubility of substance in test medium: Not reported
Results with reference substance (positive control):
- Results with reference substance valid? yes
- Mortality: Not reported
- LC50: 0.43 mg/L (96).
- Other: reference substance used: Copper(II)sulphate pentahydrate.
Reported statistics and error estimates:
Not required as a limit test
Sublethal observations / clinical signs:

                   Mortality (%) of Oryzias latipes exposed to the test chemical

                        Nominal concentration (mg/L)     Cumulative number of dead fish (% mortality)

                                                                         24 hour        48 hour        72 hour      96 hour

                        Control (())                               0(0)                 0(0)              0(0)           1(10)

                        Dispersant Control  (0)             0(0)                0(0)              0(0)            0(0)

                        100                                           0(0)                1(10)            1(10)          1(10)

 

Reference substance used was copper (II) sulphate pentahydrate & the LC50 at 96h was 0.43 mg/L.

Validity criteria fulfilled:
yes
Conclusions:
Under the conditions in which this study was performed the LC50 (96h) > 100mg/L for fish.
Executive summary:

Acute toxicity to fish has been investigated in a 96 hour test according to OECD test methods. Dissolution/dispersion agents were used to increase concentration of the substance in the test medium. The LC50 (96h) was determined to be >100 mg/L.

Description of key information

Short-term toxicity to fish: LC50 - > 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

Acute toxicity to fish has been investigated in a 96 hour test according to OECD test methods. Dissolution/dispersion agents were used to increase concentration of the substance in the test medium. The LC50 (96h) was determined to be >100 mg/L.