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Short-term toxicity to fish

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Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
2001
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data from reliable source (NITE (National Institute of Technology and Evaluation) Japan). No test report is available however dat from this source are known to be well documented and the test are performed according to GLP and OECD guidelines.
Justification for type of information:
Read-Across from (2-hydroxypropyl)trimethylammonium formate is claimed as valid for assessment of the quaternary ammonium cation, and on the basis of existing data for the anion 2-ethylhexamoic acid.
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
not specified
GLP compliance:
not specified
Analytical monitoring:
yes
Vehicle:
not specified
Test organisms (species):
Oryzias latipes
Test type:
other: Thought to be Semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Reference substance (positive control):
not specified
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.
Basis for effect:
mortality
Validity criteria fulfilled:
not specified
Conclusions:
An OECD 203 semi-static test using Oryzias latipes derived a 96hour LC50 of >100 mg/L.
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
2017
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
GLP compliance:
yes (incl. certificate)
Specific details on test material used for the study:
Identification: Hydroxypropyl, 2-, trimethylammonium formate
Synonym: DABCO TMR-2® Catalyst
Sponsor physical state/Appearance: Clear colorless liquid
Envigo physical state/Appearance: Colorless to very light blue liquid
CAS Number: 62314-25-4
Batch: Chernil.20160628.B
Purity: 95.25% active in water
Expiry Date: 28 June 2017
Storage Conditions: Room temperature, in the dark, stored over silica gel
from 08 November 2016
Analytical monitoring:
yes
Details on sampling:
Water samples were taken from the control and 100 mg/L test vessel at 0 and 72 hours from fresh media and at 24 and 96 hours from old media for quantitative analysis. The samples were stored frozen prior to analysis.
Duplicate samples and samples at 24 (fresh media), 48 (old and fresh media) and 72 hours (old media) were taken and stored frozen for further analysis if necessary.
Vehicle:
no
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
The test was carried out using juvenile rainbow trout (Oncorhynchus mykiss). Fish were obtained from Brow Well Fisheries Limited, Hebden, near Skipton, Yorkshire, UK and maintained in-house. Fish were maintained in a glass fiber tank with a "single pass" water renewal system. Fish were acclimatized to test conditions from 12 June 2017 to 19 June 2017. The lighting cycle was controlled to give a 16 hours light and 8 hours darkness cycle with 20 minute dawn and dusk transition periods.

The water temperature was controlled at approximately 14 °C with a dissolved oxygen content of greater than or equal to 9.4 mg O2/L. These parameters were recorded daily. The stock fish were fed commercial trout pellets which was discontinued approximately 24 hours prior to the start of the definitive test.
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Remarks on exposure duration:
Seven fish were exposed to an aqueous solution of the test item, at a single concentration of 100 mg/L for a period of 96 hours at a temperature of approximately 15 ºC to 16 °C under semi-static test conditions.
Post exposure observation period:
No
Hardness:
total hardness approximately 140 mg/L as CaCO3
Test temperature:
The water temperature was controlled at approximately 14 °C
pH:
7.7-8.0
Dissolved oxygen:
dissolved oxygen content of greater than or equal to 9.4 mg O2/L.
Salinity:
N/A
Nominal and measured concentrations:
Analysis of the fresh test preparations at 0 and 72 hours and old test solutions at 24 and 96 hours showed measured test concentrations to be near nominal and so the results are based on the nominal test concentration only.
Details on test conditions:
Seven fish were exposed to an aqueous solution of the test item, at a single concentration of 100 mg/L for a period of 96 hours at a temperature of approximately 15 ºC to 16 °C under semi-static test conditions.
Reference substance (positive control):
no
Key result
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:
Exposure of rainbow trout (Oncorhynchus mykiss) to the test item gave LC50 values based on the nominal concentration of greater than 100 mg/L.
There were no mortalities in 7 fish exposed to a test concentration of 100 mg/L for a period of 96 hours. There were no sub-lethal effects of exposure observed in the test.

The No Observed Effect Concentration was 100 mg/L.
It was considered unnecessary and unrealistic to test at concentrations in excess of 100 mg/L.
Reported statistics and error estimates:
An estimate of the LC50 values was given by inspection of the mortality data.
Validity criteria fulfilled:
yes
Conclusions:
The test was considered to be valid given that none of the control fish died or showed signs of stress during the test and that the oxygen concentration at the end of the test was equal to or greater than 60% of ASV (6.1 mg O2/L at 15 °C) in the control and test vessels.

Exposure of rainbow trout (Oncorhynchus mykiss) to the test item gave LC50 values based on the nominal concentration of greater than 100 mg/L. The No Observed Effect Concentration was 100 mg/L.
It was considered unnecessary and unrealistic to test at concentrations in excess of 100 mg/L.

Description of key information

Exposure of rainbow trout (Oncorhynchus mykiss) to the read-across substance TMR2 (Hydroxypropyl, 2-, trimethylammonium formate) in and an OECD 203 test gave LC50 values based on the nominal concentration of greater than 100 mg/L. The No Observed Effect Concentration was 100 mg/L.

An OECD 203 semi-static test in Oryzias latipes using the dissociation product 2-ethylhexanoic acid derived a 96hour LC50 of >100 mg/L.

On this basis an LC50 of 100 mg/L. is assigned to TMR (2-hydroxypropyl)trimethylammonium 2-ethylhexanoate).

Key value for chemical safety assessment

LC50 for freshwater fish:
100 mg/L

Additional information