Glycerides, tallow sesqui-, hydrogenated, propoxylated

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:

6 May to 6 November 1998 (experimental dates)

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

1992

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test)

Version / remarks:

draft

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Batch No.of test material: 813771
- Expiration date of the lot/batch: No data
- Purity test date: No data

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature, over silica gel in the dark
- Stability under test conditions: No data
- Solubility and stability of the test substance in the solvent/vehicle: No data
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: No data

Analytical monitoring:

yes

Details on sampling:

- Concentrations: Control and nominal 2.0 mg/L
- Sampling method: Water samples taken from control and each replicate test vessel at 0h (fresh), 24, 48 and 72 h (old and fresh), 96h (old)
- Sample storage conditions before analysis: Duplicate samples taken and frozen (~-20oC)

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Test solutions prepared by direct dispersion in water. Test material was dispersed in dechlorinated tap water with high shear mixing (7800 rpm for 5 mins), then volume adjusted to 2 litres. Stock dispersion further dispersed to 22 litres with propeller stirring for approximately 24h
- Eluate: Dechlorinated tap water
- Differential loading: No
- Controls: Dechlorinated tap water only
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): not applicable
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): None recorded by visual inspection

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: Rainbow trout
- Strain: No data
- Source: Parkwood Trout Farm, Harrietsham, Kent , UK
- Age at study initiation (mean and range, SD): No data
- Length at study end of definitive study (length definition, mean and SD): 4.6 cm (SD = 0.2 cm)
- Weight at study end of definitive study (mean and SD): 1.13 g (SD = 0.17 g)
- Method of breeding: Not applicable
- Maintenance of the brood fish: Not applicable

ACCLIMATION
- Acclimation period: 21 October to 02 November 1998
- Acclimation conditions (same as test or not): Same as test
- Type and amount of food during acclimation: Commerical trout pellets
- Feeding frequency during acclimation: Discontinued 48 h prior to study
- Health during acclimation (any mortality observed): 1% mortality in 7 days prior to test

FEEDING DURING TEST
- Food type: Not fed during test

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

No data

Test temperature:

13 +/-1oC

pH:

7.2 - 7.9

Dissolved oxygen:

8.4 - 9.8

Salinity:

No data

Conductivity:

No data

Nominal and measured concentrations:

Nominal concentration: Control and 2.0 mg/L
Measured concentration: 1.4 mg/L (dispersed with test system),

Details on test conditions:

TEST SYSTEM
- Test vessel: Covered to reduce evaporation
- Material, size, headspace, fill volume: Glass test vessels , 22 L fill volume
- Aeration: Not aerated
- Type of flow-through (e.g. peristaltic or proportional diluter): Not applicable
- Renewal rate of test solution (frequency/flow rate): Not applicable
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 2
- No. of vessels per vehicle control (replicates): Not applicable

OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16:8h Light:dark with 20 min transition period
- Light intensity: No data

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :

TEST CONCENTRATIONS
- Spacing factor for test concentrations: Limit test
- Range finding study
- Test concentrations: 0.2, 1.0 & 2.0 mg/L (nominal)
- Results used to determine the conditions for the definitive study: No mortality or symptoms observed, therefore limit test at 2.0 mg/L (nominal) for definitive study

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

> 2 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: <0.22 mg/L bioavailable

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

> 2 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: <0.22 mg/L bioavailable

Duration:

72 h

Dose descriptor:

LC50

Effect conc.:

> 2 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: <0.22 mg/L bioavailable

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 2 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: <0.22 mg/L bioavailable

Sublethal observations / clinical signs:

Nominal concn (mg/L)	Total no. organisms tested	Total no. immobilised		Observations		% effect
		24h	48h	24h	48h
Control	10	0	0	0	0	0
Control	10	0	0	0	0	0
2.0	10	0	0	0	0	0
2.0	10	0	0	0	0	0
2.0	10	0	0	0	0	0

No sub-lethal effects observed

Validity criteria fulfilled:

yes

Conclusions:

The acute toxicity of the test material to rainbow trout, based on mortality, gave a 96 hour LC50 of >2.0 mg/L (based on nominal test concentrations) and a NOEC of 2.0 mg/L, although the test substance is not toxic to aquatic organisms at the limit of solubility, which is was less than the LoQ.

Executive summary:

In a 96-h acute toxicity study rainbow trout, Oncorhynchus mykiss, were exposed to a single test concentration under semi-static conditions in accordance with the OECD test guideline 203 and in compliance with GLP. The nominal test concentrations were a control and a 2.0 mg/L test solution prepared. However, the amount of bioavailable (dissolved) test material was shown to be <LoQ (0.22 mg/L) by analysis of filtered test samples during preliminary work. The 96 hour LC50, based on nominal test concentrations was >2.0 mg/L. and the NOEC was 2.0 mg/L, although the test substance is not toxic to aquatic organisms at the limit of solubility, which is was less than the LoQ.

Description of key information

In a 96-h acute toxicity study rainbow trout, Oncorhynchus mykiss, were exposed to a single test concentration under semi-static conditions in accordance with the OECD test guideline 203 and in compliance with GLP. The nominal test concentrations were a control and a 2.0 mg/L test solution prepared. The time-weighted mean measured concentration was 1.4 mg/L. However, the amount of bioavailable (dissolved) test material was shown to be <LoQ (0.22 mg/L) by analysis of filtered test samples during preliminary work. The 96 hour LC50, based on nominal test concentrations was >2.0 mg/L. and the NOEC was 2.0 mg/L, although the test substance is not toxic to aquatic organisms at the limit of solubility, which is was less than the LoQ.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

2 mg/L