Registration Dossier

Ecotoxicological information

Short-term toxicity to fish

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to fish
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
From 29 June, 1987 to 14 August, 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
No chemical analysis performed
Justification for type of information:
Refer to the Quaternary ammonium salts (QAS) category or section 13 of IUCLID for details on the category justification. The study with the read across substance is considered sufficient to fulfil the information requirements as further explained in the provided endpoint summary.
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Qualifier:
according to
Guideline:
other: 5.1.1 "Acute Toxicity for Fish" of the EEC Directive 79/831 Annex V (methods for the determination of the ecotoxicity) (1981)
Qualifier:
according to
Guideline:
other: Proposal F1.1 "letale Wirkung bei der Regenbogenforelle of the ad hoc working group at the Umweltbundesamt Berlin for the development of ecotoxicological test methods in aquatic systems, dated June 1, 1982
GLP compliance:
not specified
Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION: The calculated amount of test sample was exactly weighed using an analytical balance and transferred quantitatively into a 2 L beaker. The suspension was stirred for 2 hours using a magnetic stirrer. Immediately afterwards, the test sample was transferred quantitatively from the beaker into the test mediumof one glass tank.
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Common name: Rainbow trout
- Strain: Salmo gairdneri
- Source: Forellenhof Fredesloh, Dr. O. Muller, 3413 Moringen 1
- Length at study initiation (length definition, mean, range and SD): 5±1 cm


ACCLIMATION
- Acclimation period: 17 d
- Acclimation conditions (same as test or not): Yes
- Acclimation vessel: 300 L
- Type of medium: The city water supply, dechlorinated via active charcoal filters with continuous aeration
- Type and amount of food: Trout food Pelletgr. S 1 (Rheinkrone Kraftfutter); stopped 24 h before test.
- Photo-period: 12 h light/12 h dark
- Health during acclimation (any mortality observed): 7% mortality observed during first 12 d acclimation phase reduced to 0.5% in next 5 d.

Test type:
static
Water media type:
freshwater
Total exposure duration:
96 h
pH:
8.0-8.1
Dissolved oxygen:
10.1-10.3 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: Glass tanks with dimensions: length 300 mm, width 200 mm and height 220 mm
- Material, size, headspace, fill volume: 10 L fill volume
- Type (delete if not applicable): Tanks were covered with glass plates assuring the aeration through Pasteur pipettes as well as the free exchange with the surrounding atmosphere, but preventing effectively any possibility for the fish to jump out of the test medium.
- Aeration: Yes, using glass tanks special aquarium aerators, brand Optima (Art.-No. A 10007, produced by Weltweit GmbH u. Co. KG, D-2981 Holm
near Hamburg). Air was bubbled into the test medium through Pasteur pipettes directly connected with the aerator by flexible PVC tubes. The air-stream was regulated with tube-clamps providing for each tank a uniform air-stream of 1 to 3 bubbles per second.
- Renewal rate of test solution (frequency/flow rate): Static
- No. of organisms per vessel: 5 fish/vessel
- No. of vessels per concentration (replicates): Two
- No. of vessels per control (replicates): Two (vessels exposed to only pure reconstituted water - negative control)
- Loading: Loading of the test medium with the solid test sample was done 2 h before the start of the test.


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted water

OTHER TEST CONDITIONS
- Photoperiod: 12 h dark/12 h light


EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Mortality and other visible abnormalities (comprising of changes of the outward appearance, the behaviour and the physiological functions of the test fish).
- Frequency: At 1 h, 24 h, 48 h, 72 hand 96 h after the start of the test.

CRITERIA FOR EVALUATION: Fish are considered dead if touching of the caudal peduncle produces no reaction and if no breathing movements are visible.

TEST CONCENTRATIONS
- Range finding study: Yes, the range finding test indicated a mortality for at least 2 mg/L.
- Test concentrations: 0.05, 0.1, 0.2, 0.5, 0.7, 1.0, 1.4, 2.0 mg/L
- Results used to determine the conditions for the definitive study: Yes
Reference substance (positive control):
not specified
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
0.2 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: equivalent to 0.1 mg a.i./L
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
0.3 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: equivalent to 0.15 mg a.i./L
Key result
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
0.5 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: equivalent to 0.25 mg a.i./L
Validity criteria fulfilled:
yes
Remarks:
but no chemical analysis performed
Conclusions:
Based on the results of the read across study, the 96 h LC50 value for the test substance is considered to be 0.15 mg/L.
Executive summary:

A study was conducted to determine the toxicity of the read across substance, C16-18 and C18-unsatd.TMAC (active: 50%), to Rainbow trout (Salmo gairdneri) according to OECD Guideline 203, in compliance with GLP. Fish (5/vessel, in duplicate) were exposed to nominal concentrations of the test substance at 0.05, 0.1, 0.2, 0.5, 0.7, 1.0, 1.4, 2.0 mg/L under static conditions. No analytical determination of the test substance was performed. Mortality and other visible effects were observed at 1, 24, 48, 72 and 96 h after the start of the test. There was 100 % mortality at concentrations ≥0.5 mg/L by 24 h and 0% mortality at 0.2 mg/L. Under the study conditions, the 96 h LC50 was determined at 0.3 mg/L (i.e., equivalent to 0.15 mg a.i./L) (Dommrose, 1987). Based on the results of the read across study, similar 96 h LC50 values can be considered for the test substance, Oleyl TMAC, for short-term toxicity to fish.

Description of key information

Based on the results of the read across study, the 96 h LC50 value for the test substance, Oleyl TMAC, is considered to be 0.15 mg/L.

Key value for chemical safety assessment

LC50 for freshwater fish:
0.15 mg/L

Additional information

A study was conducted to determine the toxicity of the read across substance, C16-18 and C18-unsatd.TMAC (active: 50%), to Rainbow trout (Salmo gairdneri) according to OECD Guideline 203, in compliance with GLP. Fish (5/vessel, in duplicate) were exposed to nominal concentrations of the test substance at 0.05, 0.1, 0.2, 0.5, 0.7, 1.0, 1.4, 2.0 mg/L under static conditions. No analytical determination of the test substance was performed. Mortality and other visible effects were observed at 1, 24, 48, 72 and 96 h after the start of the test. There was 100 % mortality at concentrations ≥0.5 mg/L by 24 h and 0% mortality at 0.2 mg/L. Under the study conditions, the 96 h LC50 was determined at 0.3 mg/L (i.e., equivalent to 0.15 mg a.i./L) (Dommrose, 1987). Based on the results of the read across study, similar 96 h LC50 values can be considered for the test substance, Oleyl TMAC, for short-term toxicity to fish.