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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
between 10 and 28 June 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
No test surrogate or analogue material
Analytical monitoring:
yes
Details on sampling:
- Concentrations: Limit of solubility (LS) (0-24 h), LS/1.78 (0-72 h), LS/3.16, LS/5.62, LS/10, and LS/17.8
- Sampling method: 5 mL taken from the new and aged test solutions
- Sample storage conditions before analysis: at -20°C
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: preparation of a stock solution of nominal 100 mg/L by stirring an appropriate amount of test substance and test water for approximately 1 day. Since still particles were occurred in the solution at the end of the stirring period, the solution was 0.45 µm filtered resulting in a saturated stock solution (LS).
- Differential loading: The LS was further diluted with test water to provide a geometric series of concentration.
- Controls: test water
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): none
- Evidence of undissolved material (e.g. precipitate, surface film, etc): none visible due to 0.45 µm filtration
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Common name: rainbow trout
- Strain: --
- Source: in-house culture at CIT from eggs obtained from Viviers de France, Piscicultures des Fontaines, Sarrance, F
- Age at study initiation (mean and range, SD):
- Length at study initiation (length definition, mean, range and SD): average 43.9 mm (40 - 50 mm), n = 70
- Weight at study initiation (mean and range, SD): average 0.90 g, n = 10
- Method of breeding: filtered and dechlorinated potable water softened by Permo water softener system of which 50% were pased through a deionizer producing ultra-pure water
- Feeding during test : none

ACCLIMATION
- Acclimation period: breeding until test start
- Acclimation conditions (same as test or not): yes
- Type and amount of food: trout chow
- Feeding frequency: twice daily ceasing 24 hours before test start
- Health during acclimation (any mortality observed): no abnormalities reported
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
No post exposure observation period
Hardness:
139 - 154 mg/L as CaCO3
Test temperature:
14.0 - 16.0°C
pH:
7.58 - 8.07
Dissolved oxygen:
6.5 - 10.0 mg/L (> 60% saturation)
Salinity:
Test was performed in freshwater.
Nominal and measured concentrations:
Limit of solubility (LS): 83.5 mg/L at test start; 81.5 mg/L at 23.9 h => geo.mean 0-23.9h = 82.5 mg/L;
LS/1.78 : 45.5-55.8 mg/L in fresh medium; 38.2-50.6 mg/L in aged test medium => geo.mean 0-71.9 h = 47.8 mg/L
LS/3.16 : 23.4-36.3 mg/L in fresh medium; 22.5-38.7 mg/L in aged test medium => geo.mean 0-96 h = 30.1 mg/L
LS/5.62 : 12.0-21.9 mg/L in fresh medium; 12.2-19.5 mg/L in aged test medium => geo.mean 0-96 h = 15.8 mg/L
LS/10 and LS/17.8 : < LOQ of 5 mg/L during whole test period
Details on test conditions:
TEST SYSTEM
- Test vessel: not specified in the report
- Aeration: none
- Type of flow-through (e.g. peristaltic or proportional diluter): none
- Renewal rate of test solution (frequency/flow rate): at 24-hour intervals
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): not applicable
- Biomass loading rate: 0.90 g/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: filtered and dechlorinated potable water softened by Permo water softener system of which 50% were pased through a deionizer producing ultra-pure water
- Ca/Mg ratio: 4 : 1
- Culture medium different from test medium: no
- Intervals of water quality measurement: at the start and end of each water renewal interval

OTHER TEST CONDITIONS
- Adjustment of pH: not specified
- Photoperiod: 16:8 h light:dark
- Light intensity: not specified

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Mortality and behavoural changes, at least every 24-hours but more frequently during the first 24 h

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.78
- Justification for using less concentrations than requested by guideline: not applicable
- Range finding study
- Test concentrations: LS, LS/10, LS/100, LS/1000,LS/10000
- Results used to determine the conditions for the definitive study: yes; all fish dead at LS but no effects at lower levels.
Reference substance (positive control):
no
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
53.7 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 95% CL: 22.9 - 82.5
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
40.5 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 95% CL: 26.9 - 82.5
Duration:
72 h
Dose descriptor:
LC50
Effect conc.:
36.6 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
32.3 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 95% CL: 15.8 - 47.8
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
15.8 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
47.8 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
- Behavioural abnormalities: In the LS, LS/1.78 and LS/3.16 some fish were lying on the bottom of the aquarium and/or showing severe loss of equilibrium, abnormal respiratory rate and immobilization before death.
- Observations on body length and weight: not determined
- Mortality of control: none
- Other adverse effects control: none
Reported statistics and error estimates:
Probit analysis; confidence interval limits were calculated according to Fieller's method.
Sublethal observations / clinical signs:

Table 1: Acute toxicity of undecylenic acid to rainbow trout - mortality data

 Observation                    Treatment (Dilution of stock solution* / geometric mean measured conc. 0- 96 h) - Number of dead fish / % dead fish
 time (h)  Control / --  LS/17.8 / < 5 mg/L  LS/10 / < 5 mg/L  LS/5.62 / 15.8 mg/L  LS/3.16 / 30.1 mg/L  LS/1.78 / 47.8 mg/L  LS / 82.5 mg/L
 4  0  0  0  0  0  0  0
 24  0  0  0  0  0  1 / 10  10 / 100
 48  0  0  0  0  0  8 / 80  10 / 100
 72  0  0  0  0  0  10 / 100  10 / 100
 96  0  0  0  0  3 / 30  10 / 100  10 / 100

* LS = limit of solubility obtained from an initial loading rate of 100 mg/L; LS/xx = dilution of LS

Validity criteria fulfilled:
no
Remarks:
see free text in section "overall remarks"
Conclusions:
The 96 -hour LC50 was calculated as 32.3 mg/L based on geometric mean measured concentrations.
Executive summary:

In an acute toxicity test, rainbow trout were exposed to the test substance undecylenic acid for 96 hours under semi-static conditions. The test was conducted in accordance with OECD Guideline 203. Mortality and sublethal effects were found only at the three highest treatment levels. A 96 -hour LC50 of 32.3 mg/l was calculated based on geometric mean measured concentrations.

Description of key information

In an acute toxicity test, rainbow trout were exposed to the test substance undecylenic acid for 96 hours under semi-static conditions. The test was conducted in accordance with OECD Guideline 203. Mortality and sublethal effects were found only at the three highest treatment levels. The 96-hour LC50 was equal to 32.3 mg/l, based on geometric mean measured concentrations. 

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
32.3 mg/L

Additional information