Quaternary ammonium compounds, bis(hydrogenated tallow alkyl)dimethyl, chlorides, reaction products with polyethylenepolyamines and tall-oil fatty acids, humates hydrochlorides

Short-term toxicity to fish

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:

22 November 2004 to 26 November 2004

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Testing done as per the UK GLP Regulations (1999) and OECD Principles as reported in the study report. Analytical monitoring of the nominal concentrations, however, was not conducted.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

Principles of method if other than guideline:

Besides the OECD method, the supporting method cited is the Paris Commission, Protocol for a Fish Acute Toxicity Test, Oslo and Paris Commission (PARCOM, 1995).

GLP compliance:

yes

Remarks:

Testing done as per the UK GLP Regulations (1999) and OECD Principles

Analytical monitoring:

no

Details on sampling:

A range-finding test was not conducted. The definitive range was selected based on other, in-house tests.

Vehicle:

no

Details on test solutions:

Water Accommodated Fractions (WAFs) of the test material were prepared in artificial seawater. The nominal concentrations based on the test material, organolignite, for the definitive test included the following: 100.0, 177.8, 316.2, 562.3 and 1000.0 mg/L.

Test organisms (species):

other: Scophthalmus maximus

Details on test organisms:

Common and species name: Juvenile turbot (Scophthalmus maximus)
Supplier: France Turbot, L'Epine, France
Batch history: Test organisms received on 10 November 2004 (batch no.: SM04007).
Observations: Batch free of malformations and appearing in good health

Test type:

semi-static

Water media type:

saltwater

Limit test:

no

Total exposure duration:

96 h

Test temperature:

Ranged from 15 degrees C plus or minus 1.5 degrees C

pH:

Ranged from 7.71 to 8.41

Dissolved oxygen:

Ranged from 91.6% to 100% saturation

Salinity:

Ranged from 32.1 parts per thousand (ppt) to 35.2 ppt

Nominal and measured concentrations:

WAFs:
100.0, 177.8, 316.2, 562.3 and 1000.0 mg/L

Details on test conditions:

Testing media: Artificial seawater from Coral Reef, Kent Sea Salt, Red Sea Fish Pharm.
Solubility of test material: sample described as insoluble in seawater
Test duration: 96 hours
Test endpoint: cessation of movement and failure to respond to tactile stimulation
Test parameters: dissolved oxygen (DO), pH, temperature and salinity values recorded at 24 hour intervals

Reference substance (positive control):

yes

Remarks:

3,5-dichlorophenol - report states that "DCP result for the most recent Turbot batch tested prior to this study was >0.6 mg/L"

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

Lethal concentration 50% (LC50) for 96 hour time period:
>1000 mg/L
Lethal concentration 50% (LC50) for 72 hour time period:
>1000 mg/L
Lethal concentration 50% (LC50) for 48 hour time period:
>1000 mg/L
Lethal concentration 50% (LC50) for 24 hour time period:
>1000 mg/L

NOEC 96h: 1000 mg/L
LOEC 96h: >1000 mg/L
No mortality in any concentrations or the control were observed.

Results with reference substance (positive control):

The test data for the reference substance, 3,5-dichlorophenol (referred to as DCP in the study report), are not presented. However, the study report does state that the, "DCP result for the most recent Turbot batch tested prior to this study was 0.6 mg/L."

Sublethal observations / clinical signs:

Validity of the test

-Test Quality Criteria

These quality criteria are in the OECD 203 guideline.

1. Mortality in the control must not exceed 10 % (or one fish if less than ten are used) by the end of the test. 2. The dissolved oxygen concentration must be at least 60 % of initial value. 3. The measured values of pH solution should not change more than 1 pH unit. 4. The test substance concentration in test mixtures should not decrease under 80 % of the initial concentration.

Quality criteria at points 1, 2 and 3 were fulfilled. No analytical determination of the test material in the WAFs was noted in the study report. Therefore, #4 test validity quality criterion was not addressed.

Validity criteria fulfilled:

yes

Conclusions:

The 96h LC50 for the Scophthalmus maximus (juvenile turbot) was calculated as > 1000 mg/L, based on nominal Water Accommodated Fraction concentrations. There was no observed mortality in the control vessels nor or in any of the tested material concentrations (100.0, 177.8, 316.2, 562.3, and 1000.0 mg/L in WAFs) for a 96 hour exposure period. All parameters measured in this study lay within acceptable tolerance limits.

Executive summary:

The acute toxicity of the test substance, organolignite, to juvenile turbot, Scophthalmus maximus, was determined in accordance with test methods OECD 203 (1992) and PARCOM (1995). Fish were exposed in semi-static conditions for 96 hours to nominal water accommodated fraction (WAF) concentrations of the test substance of 100.0, 177.8, 316.2, 562.3, and 1000.0 mg/L. No mortality was observed in any of the test concentrations or in the control.

Description of key information

The 96h LC50 for the Scophthalmus maximus (juvenile turbot) was calculated as > 1000 mg/L, based on nominal Water Accommodated Fraction concentrations. There was no observed mortality in the control vessels nor in any of the tested material concentrations (100.0, 177.8, 316.2, 562.3, and 1000.0 mg/L in WAFs) for the 96 hour exposure period.  All parameters measured in this study lay within acceptable tolerance limits.

Key value for chemical safety assessment

Marine water fish

Marine water fish

Effect concentration:

1 000 mg/L

Additional information

The acute toxicity of the test substance, organolignite, to juvenile turbot, Scophthalmus maximus, was determined in accordance with test methods OECD 203 (1992) and PARCOM (1995). Fish were exposed in semi-static conditions for 96 hours to nominal water accommodated fraction (WAF) concentrations of the test substance of 100.0, 177.8, 316.2, 562.3, and 1000.0 mg/L. No mortality was observed in any of the test concentrations or in the control. The LC50 for the marine fish species is > 1000 mg/L.