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Ecotoxicological information

Short-term toxicity to fish

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Administrative data

Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From January, 26, 2016 to February 02, 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Quality Assurance Statement is at page 4 of the report
Specific details on test material used for the study:
Batch no.: 145
Dry matter: 37.6% in water (water to 100%)
Purity: 90.4% on the dry matter
Solubility: soluble in water
Being the report done before ECHA Agreement on substance name, the name on the report is L-Glutamic acid, N-(1-oxooctyl)-,sodium salt (1:2) but the substance tested is the reference substance. All raw materials used and manufacturing process are the same
Analytical monitoring:
yes
Remarks:
Measurement of analytical total carbon (TOC) concentration with a TOC analyser
Details on sampling:
- Samples, properly diluted with deionised water with low TOC contents, have been analysed by means of an integrated sampling system directly from vials containing 40 ml volume. For each sample under test the corresponding blank is analysed.
- Samples were stable over the duration of the test (96 h).
Vehicle:
no
Remarks:
Substance is already in water solution
Details on test solutions:
Aeration: continuous with porous stones
Tanks have been lightened with white light lamps with 12 h photoperiod daily
NB: Water used has been allowed to stabilize for 48 hours to greately reduce chloribe presence
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
Length : 2 +/- 1 cm
Biomass-density: < 1 g/L
Number of animals: 7/tank
Supplier: Aquarium Center
Feeding: feedstuff in flakes
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
230 mg CaCO3/l
Test temperature:
22.8 °C
pH:
7.74
Dissolved oxygen:
65% - 74%
Nominal and measured concentrations:
Range finding test: 5 different concentrations of the active ingredient (from 0.1 to 1000 mg/l). Definitive tets: solution at 100 mg/l of the active ingredient in water
Details on test conditions:
Animals:

Control (water) and Treated groups: 7.

Check points at 3, 6, 24, 48, 72, 96 h (for visible abnormalities).

The following parameters have also been recorded during those check points: pH, dissolved O2, °C.
Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Validity criteria fulfilled:
yes
Conclusions:
Under the study conditions, the 96 h LC50 of the substance in Brachydanio rerio was determined to be >100 mg a.i./L.
Executive summary:

A study was conducted to determine the short-term toxicity of the substance to fish according to OECD Guideline 203, in compliance with GLP. Based on a range-finding study, Brachydanio rerio (7/group) were exposed to the test substance at a concentration of 100 mg/L for 96 h. Total organic carbon (TOC) concentrations were measured with a TOC analyser and the test substance was considered stable over the duration of the test. No mortalities or symptoms (visible abnormalities) were observed during the test. Under the study conditions, the 96 h LC50 of the substance in Brachydanio rerio was determined to be >100 mg a.i./L (Giarei, 2016).

Description of key information

A study was conducted to determine the short-term toxicity of the substance to fish according to OECD Guideline 203, in compliance with GLP. 

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Dose descriptor:
LC50
Effect concentration:
> 100 mg/L

Additional information

A study was conducted to determine the short-term toxicity of the substance to fish according to OECD Guideline 203, in compliance with GLP. Based on a range-finding study, Brachydanio rerio (7/group) were exposed to the test substance at a concentration of 100 mg/L for 96 h. Total organic carbon (TOC) concentrations were measured with a TOC analyser and the test substance was considered stable over the duration of the test. No mortalities or symptoms (visible abnormalities) were observed during the test. Under the study conditions, the 96 h LC50 of the substance in Brachydanio rerio was determined to be >100 mg a.i./L (Giarei, 2016).