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Diss Factsheets

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
08 Apr 2021 to 12 Apr 2021
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2021
Report date:
2021

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
June 2019
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: MEP, P.R. China, the Guidelines for the Testing of Chemicals, Effects on Biotic Systems, No. 203 “Fish Acute Toxicity Test”.
Version / remarks:
China Environmental Press, 2013.8.
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: SANCO/12571/2013
Version / remarks:
November 2013 rev.0, Implemented by 01/01/2014
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
5-amino-3-(trifluoromethyl)pyridine-2-carbonitrile
EC Number:
815-137-9
Cas Number:
573762-62-6
Molecular formula:
C7H4F3N3
IUPAC Name:
5-amino-3-(trifluoromethyl)pyridine-2-carbonitrile
Details on test material:
- Appearence : Slightly yellowish brown fine powder
- CAS Number: 573762-62-6
- Molecular formula: C7H4F3N3
- Molecular weight: 187.12
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: BI03K2005005
- Expiration date of the lot/batch: 2021-06-02 (retest date)
- Purity: 99.7%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature protected from light

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Concentrations of the test chemical were analysed at the start of the test in the fresh solutions and at the end of the test in the 96-hour old solutions. About 20 mL sample was taken from test solutions and control solution.

Test solutions

Details on test solutions:
According to the results of the range-finding test, the definitive test was carried out at 5 concentrations, and a concurrent control group was performed with 10 L test water. The details were as follows:
-Test concentration: 25.0, 35.4, 50.0, 70.7 and 100 mg/L, a control group was conducted concurrently.
-Blank Control: Test medium without test item or other additives
Preparation of test solutions:
0.2501 g, 0.3540 g, 0.5002 g, 0.7070 g and 1.0003 g test item were weighed and dissolved in 10 L of test water by magnetic stirring for 4 hours, respectively. After the test item was dissolved completely, the solutions were used for exposure.

Test organisms

Test organisms (species):
other: Rare Minnow (Gobiocypris rarus)
Details on test organisms:
Test organism name: Rare Minnow (Gobiocypris rarus)
Batch No.: Rare Minnow 20210119
Origin: The fish were reproduced in this facility.
Their parental generation was introduced from CTI Chemical Safety Evaluation Research Center (SUZHOU) CO., LTD.
Reason for the selection of the test system: This system has been selected as a recommended species of MEP, P.R. China Guideline for the Testing of Chemicals No.203
loading: <0.8 g wet weight fish/L water
total length: 1.85 - 2.00 cm
body weight: 0.0807-0.1011 g

Holding Conditions:
Acclimation: From hatching, there were no signs of disease or significant numbers of mortality. During the acclimating period, the fish were held in identical water quality and illumination conditions as used in the test.
Feeding: twice a day on weekdays and once a day during the weekends before the start of the test

Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h

Test conditions

Hardness:
190 mg/L (as CaCO3)
Test temperature:
23.6 - 25.2 °C
pH:
7.38 - 8.10
Dissolved oxygen:
75.5 - 105.5 % (ASV)
Salinity:
not relevant
Conductivity:
not indicated
Nominal and measured concentrations:
nominal concentrations: 25.0, 35.4, 50.0, 70.7 and 100 mg/L

The test concentrations were satisfactorily maintained in the range of 80-120% of nominal concentrations; see also table below in 'Any other information on materials and methods incl. tables'
Details on test conditions:
TEST SYSTEM
- Test vessel: Glass bottles
- Material, size: diameter: 22 cm, height: 35 cm
- volume: 10L
- Aeration: not during the test
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.06608 g fish/L, i.e. 0.6608 g per 10 Liter of medium
- no feeding during test

OTHER TEST CONDITIONS
- Photoperiod: 16h light daily: 8 hours darkness and an intensity of 620 - 666 lux

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.

TEST CONCENTRATIONS
- Range finding study: yes
- Test concentrations: 1.0, 10, 50 and 100 mg/L
- Results used to determine the conditions for the definitive study: yes
Reference substance (positive control):
yes
Remarks:
Potassium dichromate

Results and discussion

Effect concentrations
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
42.665 mg/L
95% CI:
>= 33.96 - <= 51.62
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
- Mortality of control: none
- Other adverse effects control: no
- the fish exposed to the test concentration of 35.4 mg/L showed visible toxic signs such as loss of balance and no death
- the fish exposed to the test concentration of 50.0, 70.7 and 100 mg/L showed visible toxic signs such as loss of balance, head up or down, floating at surface, sinking and immobility and 100% immobility occurred after 24h
Results with reference substance (positive control):
- Results with reference substance valid? yes
- LC50: 24-h LC50 = 299.86 mg/L.
Reported statistics and error estimates:
Probit method (IBM SPSS Statistics 28.0) was used to derive the LC50 value and 95% confidence limit

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The acute toxicity of T003630 to Rare Minnow (Gobiocypris rarus) was determined in a 96 hour static limit test according to the OECD guideline 203. The 96-h LC50 was 42.665 mg/L