Glycerides, tallow sesqui-, hydrogenated, propoxylated

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10 April to 10 May 2017 (experimental dates)

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

April 2004

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

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: RL686/15 (Elementis Specialties)
- Expiration date of the lot/batch: 30 October 2018
- Purity test date: 11/11/2015

Analytical monitoring:

yes

Details on sampling:

- Concentrations: Control and 100% v/v saturated solution
- Sample storage conditions before analysis: Frozen

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Test substance heated to 40oC to aid weighing. Test sustance was dissolved in test media and stirred at approximately 15000 rpm for 24 hours. After 24 hours stirring was stopped and undissolved test substance removed by filtration (0.2 um Sartorius Sartopore filter
- Eluate: Reconstituted water (Elendt M7)
- Differential loading: No
- Controls: Media control only
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): None
- Concentration of vehicle in test medium (stock solution and final test solution(s) or suspension(s) including control(s)): 100% v/v saturated solution
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): No data

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna
- Strain/clone: In-house cultures
- Source: In-house cultures
- Age of parental stock (mean and range, SD):
- Feeding during test: No

ACCLIMATION
- Acclimation period: None

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

No data

Test temperature:

220C

pH:

7.7 - 7.8

Dissolved oxygen:

8.8 - 9.1 mg O2/L

Salinity:

No data

Conductivity:

No data

Nominal and measured concentrations:

Nominal: Control and 100% v/v saturated solution
Measured: 0 hour =

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass beakers
- Type (delete if not applicable): covered to reduce evaporation
- Material, size, headspace, fill volume: Glass 150 mL beakers with approximately 100 mL test solution
- Aeration: No
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 5
- No. of vessels per vehicle control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted water (Elendt M7)
- Culture medium different from test medium: No

OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16:8 with 20 minute transition perioed
- Light intensity: 358 - 629 Lux (measured once during study)

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Immobilisation at 24 hour intervals

VEHICLE CONTROL PERFORMED: no

RANGE-FINDING STUDY
- Test concentrations: Control and 0.10, 1.0, 10 and 100% v/v saturated solution
- Results used to determine the conditions for the definitive study: Yes

Reference substance (positive control):

yes

Remarks:

Conducted between 20 - 22 October 2016; results within normal range

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

>= 0.14 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

0.14 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Nominal concn (% v/v saturated solution)	Total no. organisms tested	Total no. immobilised		Observations		% effect
		24h	48h	24h	48h
Control	20	0	0	20N	20N	0
100	20	0	0	20N	1 P 19N	0

N           No sub-lethal effects observed

P            Pale in colour

Validity criteria fulfilled:

yes

Conclusions:

The 48-hour acute toxicity, based on immobility, gave a 48-hour EC50 >0.14 mg/L (geometric mean measured concns) and a NOEC of 0.14 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 48-h acute toxicity study the aquatic invertebrate,Daphnia magna, was exposed to a single test concentration under static conditions in accordance with the OECD test guideline 202 and in compliance with GLP. The nominal test concentrations were a control and a 100% v/v saturated solution prepared at a nominal loading rate of 50 mg/L. The measured concentrations at 0 and 48-hour were 0.336 and below the LoQ (Limit of Quantification), respectively. Under the conditions of the test, the EC50 (immobility) was determined to be >0.14 mg/L based on geometric mean measured concentrations. The NOEC was calculated to be 0.14 mg/L. However, 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 48-h acute toxicity study the aquatic invertebrate,Daphnia magna, was exposed to a single test concentration under static conditions in accordance with the OECD test guideline 202 and in compliance with GLP. The nominal test concentrations were a control and a 100% v/v saturated solution prepared at a nominal loading rate of 50 mg/L. Under the conditions of the test, the EC50 (immobility) was determined to be >0.14 mg/L based on geometric mean measured concentrations. The NOEC was calculated to be 0.14 mg/L. However, 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 invertebrates

Fresh water invertebrates

Effect concentration:

1.4 mg/L