Registration Dossier

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:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
28 Feb - 03 Mar 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study
Justification for type of information:
Please see analogue approach
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
GLP compliance:
yes
Remarks:
Japanese standard GLP
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material:
PHYSICO-CHEMICAL PROPERTIES
- Melting point: 63 °C
- Boiling point: 351 °C
- Water solubility (under test conditions): 0.82 mg/L (at 25 °C)
- log Pow: 5.64
Analytical monitoring:
yes
Details on sampling:
- Sampling method: Test water was sampled directly by each vessel.
- Sample storage conditions before analysis: No storage before analysis.
Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Stock solution (300 mg/L) was diluted with dilution water.
- Controls: Blank and dispersant control
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): HCO-50
- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s)): 100 mg/L in final test solution
- Evidence of undissolved material (e.g. precipitate, surface film, etc): Testwater was white and not clear. However, no precipitate was observed.
Test organisms (species):
Oryzias latipes
Details on test organisms:
TEST ORGANISM
- Common name: Medaka
- Strain: Oryzial latipes
- Source: Yatomi Fish Farm, Yatomi, Japan
- Length at study initiation (length definition, mean, range and SD): 2.09 (1.88 - 2.36) cm
- Weight at study initiation (mean and range, SD): 0.1354 (0.0855 - 0.1928) g
- Feeding during test: No feeding

ACCLIMATION
- Acclimation period: more than 12 days
- Acclimation conditions (same as test or not): same as test
- Type of food: Tetramine
- Health during acclimation (any mortality observed): Mortality was 3% during 7 days before exposure

Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
41.0 mg/L (as CaCO3)
Test temperature:
23.5 - 24.3 °C
pH:
6.8 - 7.0
Dissolved oxygen:
5.2 - 11.4 mg/L
Nominal and measured concentrations:
Nominal concentration: 10 mg/L
Measured concentration: 6.9 mg/L (geometric mean)
Details on test conditions:
TEST SYSTEM
- Test vessel: 3 L beaker
- Material, fill volume: glass, 3 L
- Aeration: no
- Renewal rate of test solution (frequency/flow rate): once in 24 hours
- 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): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:charcoal-treated, dechlorinated tap water in Nagoya, Japan
- Alkalinity: 10.0 mg/L
- Culture medium different from test medium: same as test

OTHER TEST CONDITIONS
- Photoperiod: 16/8 (light/dark)

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
mortality, general condition, abnormal behaviour, pH, dissolved oxygen, temperature.

TEST CONCENTRATIONS
- Range finding study: Performed
- Test concentrations: 125 mg/L
- Results used to determine the conditions for the definitive study: No mortality was observed in 125 mg/L and LC50 for 96 hours was > 125 mg/L. Based on this result, test concetration was setted as 10.0 mg/L where the test substance can be diluted maximum with 100 mg/L dispersant.
Reference substance (positive control):
yes
Remarks:
copper sulfate pentahydrate (analytical grade)
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 6.9 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- Behavioural abnormalities: No abnormal behaviour was observed in all groups.
- Mortality of control: 0%
- Other adverse effects control: No adverse effects were observed in control and vehicle control group.
- Abnormal responses: No abnormal responses were observed in all groups.
Results with reference substance (positive control):
- Results with reference substance valid? Yes
- LC50: 0.59 mg/L

Table 1. Measured concetration

Nominal Concentration

(mg/L)

Measured Concentration ,mg/L

(Percent of nominal)

0 Hour

new

48 Hour

old

Geometric Mean

Control

< 0.8

< 0.8

-

Dispersant control

< 0.8

< 0.8

 

10.0

6.3

(63)

7.6

(76)

6.9

(100)

new: freshly prepared test solutions

old: test solutions after 24 hours exposured period

Table 2. Mortality of Medaka

Nominal concentration (mg/L)

Mean measured concentration

(mg/L)

Cumulative mortality (Percent Mortality)

24 Hour

48 Hours

72 Hours

96 Hours

Control

-

0 (0)

0 (0)

0 (0)

0 (0)

Dispersant control

-

0 (0)

0 (0)

0 (0)

0 (0)

10

6.9

0 (0)

0 (0)

0 (0)

0 (0)

Validity criteria fulfilled:
yes

Description of key information

An acute fish test with 2 -hexyldecanoic acid is not available.

The short-term toxicity to fishes of the source substance palmitic acid was assessed in a semi-static 96 h acute study in

Oryzias latipes

according to OECD guideline 203. The result of this study was an 96h-EC50 of > 6.9 mg/l.

Key value for chemical safety assessment

LC50 for freshwater fish:
6.9 mg/L

Additional information

An acute fish test with 2 -hexyldecanoic acid is not available.

The short-term toxicity to fishes of the source substance palmitic acid was assessed in a semi-static 96 h acute study in

Oryzias latipes according to OECD guideline 203. The result of this study was an 96h-EC50 of > 6.9 mg/l.