Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2020

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Taurine
EC Number:
203-483-8
EC Name:
Taurine
Cas Number:
107-35-7
Molecular formula:
C2H7NO3S
IUPAC Name:
2-aminoethanesulfonic acid
Specific details on test material used for the study:
CAS-No.: 107-35-7
Batch No.: XP19124394
Purity: 99.4 % (assay on the dried basis) according to certificate of analysis
Certificate of Analysis Date: December 31, 2019
Aggregate State at Room Temperature: Solid
Colour: White
Expiry Date: December 25, 2022
Storage Conditions at Test Facility: At 20 ± 5 °C, in the dark

Test solutions

Vehicle:
no

Test organisms

Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Common name: Rainbow trout (Oncorhynchus mykiss)
- Source: The test fish were obtained from Forellenzuchtbetrieb Störk, 88348 Bad Saulgau, Germany
- Age at study initiation (mean and range, SD): Juveniles
- Length at study initiation (length definition, mean, range and SD):
- Weight at study initiation (mean and range, SD): The mean body length of the fish* in the test was 4.20 cm ± 0.2 cm (Mean ± SD), the mean body wet weight 0.72 g ± 0.1 g (Mean ± SD)

ACCLIMATION
- Acclimation period: All fish were obtained and held in the laboratory for at least 9 days before the start of the test.
- Acclimation conditions (same as test or not): They were held in water of the quality to be used in the test for at least seven days immediately before testing under the following conditions:
Light: 12 hours photoperiod daily
Temperature: 10 - 14 °C
Oxygen concentration: at least 80 % of the air saturation value
Feeding: three times per week or daily until 24 hours before the test was started
During the last 7 days prior to the start of the test no fish (0 %) died in the test fish batch. Therefore the mortalities in the fish batch were below 5 % and the fish batch was accepted.

Light Regime: 12 h light : 12 h dark; 30 min dawn/dusk period was provided
Light Intensity: 550 to 610 lux

Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h

Test conditions

Hardness:
40 – 250 mg/L CaCO3, preferably < 180 mg/L CaCO3
Test temperature:
12.8 to 13.9 °C
pH:
7.2 to 8.1
Dissolved oxygen:
95 to 101 % of the air saturation value
Nominal and measured concentrations:
100 mg test item/L (spacing factor 2.2) and a control.

Results and discussion

Effect concentrationsopen allclose all
Key result
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The toxic effect of the test item Taurine to Rainbow Trout (Oncorhynchus mykiss) was assessed in a semi-static limit test. Based on the test results the 96-hour LC50 was determined to be > 100 mg test item/L based on nominal concentrations. The NOEC was determined to be ≥ 100 mg test item/L also based on nominal concentrations.
The initial concentrations and the maintenance of the exposure concentrations during the test were verified in the analytical part. All reported results refer to nominal values since the concentrations of the test item were within ± 20 % of the nominal concentrations during the test.
Executive summary:

In the control and the only test concentration of 100 mg test item/L, all fish survived until the end of the experiment and showed no sublethal effects during the exposure time.


The LC50 could not be quantified due to the absence of toxicity of the test item. The NOEC and the LOEC were determined directly from the raw data.