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Ecotoxicological information

Short-term toxicity to fish

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Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
The study was completed between 21 October and 29 December 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
GLP compliance:
yes
Test material information:
Composition 1
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Batch No.of test material: 16020201
- Expiration date of the lot/batch: 21 March 2021
- Purity: 99.56%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Stability under test conditions: No data
- Solubility and stability of the test substance in the solvent/vehicle: Sparingly soluble in water


Analytical monitoring:
yes
Details on sampling:
- Concentrations: 100% of saturated solution (100 mg/L, nominal)
- Sample storage conditions before analysis: Frozen (<= -15oC)
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Nominal 100 mg/L test solution in test medium prepared by magnetic stirring for 3 days, settling for 1 hour followed by siphoning through glass wool
- Controls: Test medium only
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): None
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): Test solution observed to be hazy
Test organisms (species):
Cyprinus carpio
Details on test organisms:
TEST ORGANISM
- Common name: Common carp
- Strain: No data
- Source: Zodiac proefacc, 'De Haar Vissen', Wageningen University and Research Centre, The Netherlands
- Age at study initiation (mean and range, SD): No data
- Length at study initiation (length definition, mean, range and SD): 2.8 +/- 0.2 cm
- Weight at study initiation (mean and range, SD): 0.28 +/- 0.10 g
- Method of breeding: F1 from single parent-pair
- Maintenance of the brood fish: no data

ACCLIMATION
- Acclimation period:
- Acclimation conditions (same as test or not):
- Type and amount of food during acclimation:
- Feeding frequency during acclimation:
- Health during acclimation (any mortality observed):
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
No data
Test temperature:
22+/-2oC
pH:
7.4 - 8.1
Dissolved oxygen:
7.0 - 8.5 mg 02/L
Salinity:
No data
Conductivity:
No data
Nominal and measured concentrations:
Nominal: Control and 100% of a 100 mg/L saturated solution
Meansured: Control and 1.3 mg/L (mean measured)
Details on test conditions:
TEST SYSTEM
- Test vessel: 6.5 L all glass
- Type (delete if not applicable): open
- Fill volume: 5 L
- Aeration: No
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.39 g/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Adjusted ISO medium
- Culture medium different from test medium: No

OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 hours
- Light intensity: No data

TEST CONCENTRATIONS
- Spacing factor for test concentrations: Limit test
- Range finding study: 1.0, 10 and 100% of a 100 mg/L saturated solution (nominal)
- Results used to determine the conditions for the definitive study: No mortalities or symptoms of toxicity observed in range-finding study
Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 1.3 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality

Nominal test concn (% SS at 100 mg/L)

Mean measured concn (mg/L)

No. fish

Cumulative mortality

Total mortality

2.5h

24h

48h

72h

96h

Control

-

7

0

0

0

0

0

0

100

1.3

7

0

0

0

0

0

0

SS – saturated solution

Validity criteria fulfilled:
yes
Conclusions:
The 96-hour LC50 based on an average test concentration and no mortalities was >1.3 mg/L (mean measured concentration). The test item had no acute toxic effects on common carp (Cyprinus carpio) up to the nominal test item concentration of 100% saturated solution of a 100 mg/L test solution. Due to the very low solubility of 4,4’-(1-phenylethane-1,1-diyl)bis(heptyloxybenzene) in the test medium, concentration levels that may be toxic for fish could not be reached. The laboratory study report stated that the test item was not completely soluble in the test medium at the loading rate initially prepared.
Executive summary:

A 96-hour acute toxicity study with common carp (Cyprinus carpio) was conducted in accordance with the OECD test guideline 203 and in compliance with GLP.

A limit test was performed with a single test concentration of 100% saturated solution of a nominal 100 mg/L solution, under static conditions. The mean measured test concentration was determined to be 1.3 mg/L

Under the conditions of the test, the 96-hour LC50 (mortality) was determined to be >1.3 mg/L, based on mean measured concentrations.

Due to the very low solubility of 4,4’-(1-phenylethane-1,1-diyl)bis(heptyloxybenzene) in the test medium, concentration levels that may be toxic for fish could not be reached. The laboratory study report stated that the test item was not completely soluble in the test medium at the loading rate initially prepared.

This acute toxicity study is considered acceptable and satisfies the guideline requirement for short-term toxicity to fish.

Description of key information

In a reliable (Klimisch 1) 96-hour acute toxicity study, common carp (Cyprinus carpio) were exposed to a single test concentration (limit test) under static conditions in accordance with the OECD test guideline 203 and in compliance with GLP.

Under the conditions of the test, the LC50 (mortality) was determined to be >1.3 mg/L, based on mean measured concentrations.

The EC50 value is greater than the limit of solubility of the test substance.

The test validity criteria were met and there were no significant deviations noted to affect the integrity of the study. This acute toxicity study is considered acceptable and satisfies the guideline requirements for a short-term toxicity study to fish.

Key value for chemical safety assessment

LC50 for freshwater fish:
1.3 mg/L

Additional information