Glycerides, C8-18 and C18-unsatd.

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:

Not reported

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to ISO 14669:1999 guideline. GLP compliance not reported. No analytical verification of test concentrations.

Justification for data waiving:

other:

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: ISO 14669:1999 "Water quality" Part 5: Biological methods Section 5.24: Determination of acute lethal toxicity to marine copepods (Copepoda, Crustacea)

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Glycerides, C8-18, C18-unsatd.

IUPAC Name:

Glycerides, C8-18, C18-unsatd.

Constituent 2

Reference substance name:

Glycerides, C8-18 and C18-unsatd.

EC Number:

266-946-3

EC Name:

Glycerides, C8-18 and C18-unsatd.

Cas Number:

67701-28-4

Molecular formula:

Triglycerides containing a glycerol backbone esterified to fatty acids with a carbon chain length of C8-18 as well as unsaturated C18 fatty acids

IUPAC Name:

Tri(C8-18 and C18-unsatd. fatty acyl)glycerol

Details on test material:

- Name of test material (as cited in study report): Palm kernel stearin (CAS N° 92129-07-2, EC N° 295-808-5); under the SDA nomenclature, the name of this substance is ‘Glycerides, C8-18, C18-unsatd.’
- Physical state: Cream/yellow solid
- Expiration date of the lot/batch: Apr. 28, 2004
- Storage condition of test material: Stored in the dark at room temperature

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
Not applicable

Sampling and analysis

Analytical monitoring:

not specified

Details on sampling:

Not applicable

Test solutions

Vehicle:

yes

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Water accommodated fraction (WAF) methodology
- Preparation: WAFs were prepared by adding test material to the test medium (sterilised natural seawater) to give loading rates of 10, 100 and 1,000 mg/L. In order to mix the test material, which was solid at room temperature, the sample was microwaved on full power for approximately 2 minutes until it became liquid. The contents of the WAF vessels were then stirred using a magnetic stirrer, at 300 rpm, for 24 h, in a controlled environment room set at 20 ± 2 °C and then left to settle for a minimum of 2 h (range 2 – 4 h), to allow the undissolved material to separate out. The aqueous phases - the WAFs – were then drawn off via the tap for use in the tests. Control media was sterilised seawater.

Test organisms

Test organisms (species):

other: Acartia tonsa

Details on test organisms:

TEST ORGANISM
- Source: Guernsey Sea Farms, Vale, Guernsey
- Age at study initiation (mean and range, SD): 13-15 d
- Food type: Mixed marine algae supplied with the organisms
- Amount, frequency: Ad libitum

Study design

Test type:

static

Water media type:

saltwater

Limit test:

no

Total exposure duration:

48 h

Remarks on exposure duration:

h

Post exposure observation period:

None

Test conditions

Hardness:

No data

Test temperature:

20 ± 2 °C

pH:

7.7-8.3 (at time 0), 8.1-8.2 (after 48 h)

Dissolved oxygen:

8.6-8.9 mg/L (at time 0), 7.6-8.9 (after 48 h)

Salinity:

32-33 %

Nominal and measured concentrations:

Nominal concentration: 10, 100 & 1,000 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: Glass crystallising dishes, 150 mL
- Aeration: No
- Renewal rate of test solution (frequency/flow rate): Not renewed
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): Three
- No. of vessels per control (replicates): Three
- No. of vessels per vehicle control (replicates): Three


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Natural seawater, collected off the beach at Kinmel Bay to the west of Rhyl, Flintshire, N. Wales
- Total organic carbon (mean of three replicates at time 0): 28.3, 28.6 and 29.2 mg/L for 10, 100 and 1000 mg/L loading rate, respectively


OTHER TEST CONDITIONS
- Photoperiod: 16 h light/8 h dark cycle
- Temperature: 20 ± 2 °C

Reference substance (positive control):

yes

Remarks:

3,5-dichlorophenol; 1 mg/L

Results and discussion

Effect concentrations

Duration:

48 h

Dose descriptor:

EL50

Effect conc.:

> 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

The WAF prepared from palm kernel stearin was found to be not toxic to A. tonsa, with 48 h EL50 values exceeding 1000 mg/L, the highest loading rate tested.

Results with reference substance (positive control):

- Results with reference substance valid? yes
- Other: The percentage of A. tonsa that were immobilised when exposed to 1 mg/L 3,5-DCP was 58 % after 48 h.

Reported statistics and error estimates:

No data

Any other information on results incl. tables

Table 1: Immobilisation of A. tonsa exposed to WAF of palm kernel stearin and 1 mg/L solution of reference compound 3,5-DCP

Test material	Loading rate (mg/L)	Number of A. tonsa exposed	Cumulative Number (N) and Percentage (P) of A. tonsa immobilised after exposure period of:
			24 h		48 h
			N	P	N	P
Control		35	1	3	4	11
Palm kernel stearin	10	33	2	6	3	9
	100	36	1	3	5	14
	1000	39	5	13	10	26
3,5-DCP	1	33	4	12	19	58

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Under the test conditions, the 48 h EL50 of the test material was determined to be > 1,000 mg/L.

Executive summary:

A study was conducted to evaluate the acute toxicity of the palm kernel stearin to Acartia tonsa under static conditions. The procedures followed ISO 14669:1999 "Water quality" Part 5: Biological methods Section 5.24: Determination of acute lethal toxicity to marine copepods (Copepoda, Crustacea).

Acartia tonsa were exposed to water accommodated fractions prepared from the test material at concentrations ranging from 10 to 1,000 mg/L for 48 h and immobility was determined at 24 and 48 h.

 

Under the test conditions, the 48 h EL50 of the test material was determined to be > 1,000 mg/L.