Reaction product of 2-Hexyldecan-1-ol, 2-Octyldodecan-1-ol and Lauric acid

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: well documented study according to OECD Guideline and GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2-hexyldecan-1-ol

EC Number:

219-370-1

EC Name:

2-hexyldecan-1-ol

Cas Number:

2425-77-6

Molecular formula:

C16H34O

IUPAC Name:

2-hexyldecan-1-ol

Details on test material:

- Name of test material: 2-hexyl-1-decanol
- Substance type: pure active substance
- Physical state: liquid
- Analytical purity: 98.6 %
- Lot/batch No.: 03507
- Expiration date of the lot/batch: 2012-04-01
- Storage condition of test material: room temperature, protected from moisture and light

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations: the tested saturated solution was visually clear throughout exposure. The saturated solution and the control were analysed via GC-MS in the fresh medium (0 h) and in the old medium (48 h).
- Sampling method: 1 L of the samples were extracted with 10 mL n-Hexane. From each sample 300 µL extract were mixed with 150 µL MSTFA (N-Methyl-N-(trimethylsilyl)trifluoroacetamide) and derivatised in a waterbath (50°C) for 1 hour. Afterwards the solutions were evaporated to dryness, filled up to 3 mL with Dichloromethane : n-Hexane (50 : 50) and analysed.
- Sample storage conditions before analysis: All samples were analysed directly after sample preparation.

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: A saturated solution was prepared with a nominal loading of 2 mL test item/L corresponding to 1600 mg/L 5 days prior application. The test item was placed on the surface of the dilution water. A slow stirring procedure in a closed bottle was applied. Gently stirring (to avoid the formation of an emulsion) was carried out for 5 days. All equipment and the dilution water were autoclaved to prevent biodegradation.
- Controls: dilution water without thest item.
- Evidence of undissolved material (e.g. precipitate, surface film, etc): nothing mentioned

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Strain: Daphnia magna STRAUS (Clone 5)
- Source: Institut für Wasser-, Boden und Lufthygiene (WaBoLu), Germany
- Age at study initiation: 2 to 24 h old daphnids were used for the definitive study. They were obtained by removing the mother animals twice within 22 h.
- Feeding during test: No

ACCLIMATION
- Acclimation period: at least 2 h
- Acclimation conditions: in dilution water

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Post exposure observation period:

no

Test conditions

Hardness:

160 - 180 mg CaCO3 / L

Test temperature:

18-22 °C ± 1°C

pH:

7.8 ± 0.2

Dissolved oxygen:

saturated solution: 7.92 - 8.40 mg/l
Control: 8.39 - 8.95 mg/l

Salinity:

Elendt M4, according to Elendt (1990): (5.76 mg KCl, 64.8 mg NaHCO3, 294 mg CaCl2 * 2 H2O, 123 mg MgSO4 * 7 H2O)/L water

Nominal and measured concentrations:

nominal: 1600 mg/l
measured: 0h: 0.0350 mg/L; 48 h: 0.0095 mg/L, corresponding to a final recovery rate of 27%.

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Material, size, fill volume: glass beaker (4 cm ID x 7 cm), 50 ml capacicty
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: ISO test water according to OECD 202, Annex 3

OTHER TEST CONDITIONS
- Photoperiod: 16/8 h light/dark cycle
- Light intensity: diffuse light, max. 20 µE/(m²xs)

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : immobilization after 24 and 48 h

TEST CONCENTRATIONS
- Range finding study: A non GLP preliminary range finding test was conducted under static conditions in algae dilution water (acc. to OECD 201).
- Test concentrations: nominal 1600 mg/l
- Results used to determine the conditions for the definitive study: no immobilization at any observation time

Reference substance (positive control):

yes

Remarks:

potassium dichromate (once per month, test conducted April 7 to 8, 2010)

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

> 0.035 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95% not applicable

Effect concentrations 2

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 0.035 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95% not applicable

Effect concentrations 3

Duration:

24 h

Dose descriptor:

EC100

Effect conc.:

> 0.035 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 4

Duration:

48 h

Dose descriptor:

EC100

Effect conc.:

> 0.035 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 5

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

0.035 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 6

Duration:

48 h

Dose descriptor:

LOEC

Effect conc.:

> 0.035 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mobility

Results with reference substance (positive control):

- Results with reference substance valid?: yes
- EC50: 1.78 mg/l (CI 1.46 - 2.18 mg/l) after 24 hours

Any other information on results incl. tables

Daphnids Incapable of Swimming after 24 and 48 hours of exposure

concentration (mg/l)	24 hour values			48 hour values
	number		%	number		%
	mobile MV	immobile	immobile	mobile MV	immobile	immobile
0 (control)	20	0	0	20	0	0
0.035	20	0	0	19	1	5

MV = 20 (4 replicates with 5 daphnids each); Immobilization rates of < 10% are seen to be not significant.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Executive summary:

In the acute immobilization test with Daphnia magna (STRAUS) the effects of the saturated solution* with a nominal loading of 1600 mg/L, which corresponds to 2 mL/L, as a limit concentration of the test item 2-Hexyl-1-decanol (batch number: 03507) were determined according to OECD 202 (2004). The limit test was conducted under static conditions over a period of 48 h.

20 test organisms were exposed to the saturated solution and the control. The saturated solution and the control were analysed via GC-MS in the fresh media (0 h) and in the old media (48 h). Details of the analytical method are given in part 9. The initially measured concentration was determined to be 0.0350 mg/L in the fresh media at test start (0 h). At test end (after 48 hours) the finally measured concentration was determined to be 0.00950 mg/L, corresponding to a recovery rate of 27 % of the initially measured value.

At the saturated solution* of the test item 2-Hexyl-1-decanol with a nominal loading of 1600 mg/L (2 mL test item/L), which corresponds to the initially measured concentration of 0.0350 mg/L, no effect to Daphnia magna was observed.

EC50 (48h) = > 0.035 mg/L