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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:
2015-12-04 to 2016-01-25
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
no
Qualifier:
according to
Guideline:
ISO 7346-1 (Determination of the Acute Lethal Toxicity of Substances to a Freshwater Fish [Brachydanio rerio Hamilton-Buchanan (Teleostei, Cyprinidae)] - Part 2: Semi-static method)
Deviations:
no
Qualifier:
according to
Guideline:
other: • Guidance document on aquatic toxicity testing of difficult substances and mixtures, OECD series on testing and assessment number 23, December 14, 2000.
Deviations:
no
GLP compliance:
yes (incl. certificate)
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No. of test material: I15FB2768
- Expiration date of the lot/batch: 01 July 2017 (retest date)
- Purity: 100% (based on base titration assay)

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature
- Stability under test conditions: no data
Analytical monitoring:
yes
Details on sampling:
- Sampling method: samples for possible analysis were taken from both test groups at the start of the test and after 72 hours from the freshly prepared solutions. At the first renewal (t=24h) and at the end of the test from the 24h old solutions. 2.0 mL of volume was taken
- Sample storage conditions before analysis: the samples were stored in a freezer. Additionally, reserve samples of 2.0 mL were taken for possible analysis
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Due to an expected low water solubility of the test substance saturated solutions (SS) were prepared. The preparation of test solutions started with a loading rate of 100 mg/L applying a two-day period of magnetic stirring at room temperature, mostly in the dark. The obtained mixture was filtered through a 0.45 μm membrane (RC55, Whatman) to remove the undissolved fraction. The filter was pre-conditioned with a small volume of test solution that was discarded. The obtained saturated solution (SS) was used as the highest test concentration and was light yellow coloured. Lower test concentrations were prepared by subsequent dilutions of the SS in test medium and were clear and colourless. During the final limit test solutions were renewed on a daily basis.
- Evidence of undissolved material (e.g. precipitate, surface film, etc): All aqueous solutions were clear and colourless with exception of the highest concentration which was slightly yellowish.
Test organisms (species):
Cyprinus carpio
Details on test organisms:
TEST ORGANISM
- Common name: Carp
- Source: Zodiac, proefacc, "De Haar Vissen", Wageningen University and Research Centre, The Netherlands
- Length at study initiation (length definition, mean, range and SD): range-finding test: 2.1 ± 0.1 cm, final test: 2.8 ± 0.3 cm
- Weight at study initiation (mean and range, SD): range-finding test: 0.27 ± 0.08 g, final test 0.31 ± 0.09 g
- Feeding during test: no

ACCLIMATION
- Acclimation period: at least 12 days after delivery
- Acclimation conditions (same as test or not): yes
- Type and amount of food: pelleted fish food
- Feeding frequency: daily
- Health during acclimation (any mortality observed): mortality less than 5% seven days before test
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
not reported
Test temperature:
20.7-21.7°C
pH:
7.4-7.9
Dissolved oxygen:
6.9-9.4
Salinity:
not relevant
Nominal and measured concentrations:
Nominal concentrations (mg/L): A SS prepared at 100 mg/L
Measured concentrations (mg/L) at t= 0 days: 0.0401
Measured concentrations (mg/L) at t= 1 day (old): 0.0342
Measured concentrations (mg/L) at t= 3 days (fresh): 0.0334
Measured concentrations (mg/L) at t= 4 days (old): 0.0312
Details on test conditions:
TEST SYSTEM
- Test vessel: beaker
- Material, size, headspace, fill volume: 6.5L, all-glass filled with 5L test solution
- Aeration: not during the test
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): not reported
- No. of vessels per control (replicates): not reported

OTHER TEST CONDITIONS
- Adjustment of pH: 7.7 ± 0.3
- Photoperiod: 16h light daily

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Fish were considered to be dead when no reaction was observed after touching the caudal peduncle and visible breathing movements were absent. In addition, fish that were convulsing or showing other severe forms of distress not considered transient in nature and likely to become more severe before the exposure is terminated, will be sacrificed for humane reasons. These fish will be treated as having died in the test, based on OECD guideline on humane endpoint (ENV/JM/MONO/(2000)7).

TEST CONCENTRATIONS
- Range finding study: combined/range finding study was performed
- Test concentrations: 1.0, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: yes
Reference substance (positive control):
yes
Remarks:
pentachlorophenol
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- Mortality of control: none
- Other adverse effects control: no
- Abnormal responses: none
Results with reference substance (positive control):
- Results with reference substance valid? yes
- Mortality:
- EC50/LC50: 96h-LC50 = 0.24 mg/L. the sensitivity of the daphnia was within the range determined with the historical data collected at WIL Research Europe.
Reported statistics and error estimates:
No LC50 could be calculated because the test item proved to be non-toxic (LC50 > maximum soluble concentration).
Validity criteria fulfilled:
yes
Conclusions:
The acute toxicity of T001325 to Carp was determined in a 96-hour static test according to the OECD guideline 203.
The 96h-LC50 exceeded 35 µg/L being the average measured concentration in a saturated solution prepared at a loading rate of 100 mg/L. This concentration was considered the maximum soluble concentration in test medium. In conclusion, the test item T001325 clearly had no toxic effect to Carp up to the maximum solubility in medium obtained with a loading rate of 100 mg/L. The results of the test can be considered reliable without restriction.

Description of key information

The study of Migchielsen (2016) investigating the acute toxicity of T001325 in carp according to OECD guideline 203, was considered as the key study for endpoint coverage. The 96h-LC50 exceeded 35 µg/L being the average measured concentration in a saturated solution prepared at a loading rate of 100 mg/L. This concentration was considered the maximum soluble concentration in test medium. Based on the results it can be considered that T001325 is not harmful to fish.

Key value for chemical safety assessment

LC50 for freshwater fish:
100 mg/L

Additional information