Oxidised Crude Tall Oil

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10/12/2012 - 26/03/2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study comparable to guideline under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Principles of method if other than guideline:

The study was performed to assess the acute toxicity of the test item to Daphnia magna. The method followed was designed to be compatible with the OECD Guidelines for Testing of Chemicals (April 2004) No 202, "Daphnia sp., Acute Immobilisation Test" referenced as Method C.2 of Commission Regulation (EC) No. 440/2008.

The test was performed on a Water Accommodated Fraction (WAF).

GLP compliance:

yes (incl. QA statement)

Remarks:

Department of Health of the Government of the UK, 30 November 2012

Test material

Test material information

Constituent 1

Reference substance name:

Oxidised Crude Tall Oil

EC Number:

938-639-0

Molecular formula:

C17-20H29-35CO2H. O6-10

IUPAC Name:

Oxidised Crude Tall Oil

Test material form:

liquid: viscous

Details on test material:

Substance type: UVCB
Physical state: viscous liquid
Purity: 100%
Storage condition of test material : room temperature in the darkuid

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations:
Range-finding pre-test: 1.0, 10 and 100 mg/L at 0 and 48 hours.
Definitive test concentrations: 10, 18, 32, 56 and 100 mg/L (loading rates)

- Sample storage conditions before analysis: - 20 degrees C

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Stirring duration: 23 hours
- Loading: Pre-test; 1, 10, 100 mg/L; Definitive test; 10, 18, 32, 56, 100 mg/L

Test organisms

Test organisms (species):

Daphnia sp.

Details on test organisms:

The test was carried out using 1st instar Daphnia magna derived from in-house laboratory cultures.

Adult Daphnia were maintained in 150 mL glass beakers containing Elendt M7 medium in a temperature controlled room at approximately 20 degrees c. The lighing cycle was controlled to give a 16 hours light and 8 hours darkness cycle with 20 minute dawn and dusk transition periods. Each culture was fed daily with a mixture of algal suspension (Desmodesmus subspicatus) and Tetramin flak food suspension. Culture conditions ensured that reproduction was by parthenogenesis. Gravid adults were isolated the day before initiation of the test, such that the young daphnids produced overnight were less than 24 hours old. These young were removed from the cultures and used for testing. The diet and diluent water are considered not to contain any contaminant that would affect the integrity or outcome of the study.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test conditions

Hardness:

250 mg/L as CaCO3

Test temperature:

21 - 22 degrees C

pH:

8.1-8.2

Dissolved oxygen:

8.5 - 8.8 mg/L

Nominal and measured concentrations:

Nominal: 0, 100 mg/L
Measured (expressed as TWA): Pre test: 2.44 & 7.78 mg/ L (corresponding to 10 and 100 mg/L WAF); Definitive test: 1.72, 1.80, 5.07, 5.34 & 8.44 (corresponding to 10, 18, 32, 56 & 100 mg/L WAF)

Details on test conditions:

TEST SYSTEM
- Test vessel: 250 mL (covered)
- Fill vlume: 200 ml
- No. of daphnids per vessel : 5
- No. of replciates : 4

TEST MEDIUM
- Dilution water: reconstitued water
- pH : 7.8 +/- 0.2

TEST CONCENTRATIONS
- Pre-test: 1.0, 10 & 100 mg/L
- Definitive test: 10, 18, 32, 56 & 100 mg/L

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

48 h

Dose descriptor:

EL50

Effect conc.:

75 mg/L

Nominal / measured:

nominal

Conc. based on:

other: WAF

Basis for effect:

mobility

Remarks on result:

other: 95%CL: 56 - 100 mg/L

Effect concentrations 2

Duration:

48 h

Dose descriptor:

NOELR

Effect conc.:

56 mg/L

Nominal / measured:

nominal

Conc. based on:

other: WAF

Basis for effect:

mobility

Effect concentrations 3

Duration:

48 h

Dose descriptor:

LOELR

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

other: WAF

Basis for effect:

mobility

Results with reference substance (positive control):

- Results with reference substance valid? Yes
- EC50/LC50: EC50 (48h) = 0.45 mg/L, thus within the normal range for this refernce item.

Any other information on results incl. tables

1. Cumulative Immobilization Data in the Range-finding test:

Nominal Loading rate (mg/L)	Cumulative Immobilized daphnia (Initial population: 10 per replicates)
	24 hours	48 hours
Control	0	0
1	0	0
10	0	0
100	10	10

1. Cumulative Immobilization Data in the Definitive test:

Nominal Loading rate (mg/L)	Cumulative Immobilized daphnia (Initial population: 5 per replicates)
	24 hours						48 hours
	R1	R2	R3	R4	Total	%	R1	R2	R3	R4	Total	%
Control	0	0	0	0	0	0	0	0	0	0	0	0
10	0	0	0	0	0	0	0	0	0	0	0	0
18	0	0	0	0	0	0	0	0	0	0	0	0
32	0	0	0	0	0	0	0	0	0	0	0	0
56	0	0	0	0	0	0	0	0	0	0	0	0
100	4	4	4	4	16	80	5	5	5	5	20	100

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Daphnids were exposed to concentrations (WAFs) of the test item of 10, 18, 32, 56 & 100 mg/L. The No Observed Effcet Loading Rate (NOEL) was 56 mg/L and the Lowest Observed Effect Loading Rate (LOEL) was 100 mg/L

Executive summary:

Daphnids were exposed to concentrations (WAFs) of the test item of 10, 18, 32, 56 & 100 mg/L. The No Observed Effect Loading Rate (NOEL) was 56 mg/L (measured TWA 5.34 mg/L) and the Lowest Observed Effect Loading Rate (LOEL) was 100 mg/L (measured TWA 8.44 mg/L).