acetalization product between glucose and C16-18(even numbered)- alcohol

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:

2006-11-12 to 2007-02-15

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

GLP compliance:

yes (incl. QA statement)

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Substance type: UVCB
- Physical state: pearls of wax
- Composition of test material, percentage of components: cetearyl alcohol 80%; cetearylglucoside 20%
- Purity test date: composition , dry matter>99%
- Lot/batch No.: T62615
- Expiration date of the lot/batch: 08-06-2007 (re-test)
- Stability under test conditions: water 96h
- Storage condition of test material: room temperature at 20+-5°C

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
PHYSICO-CHEMICAL PROPERTIES
- Melting point: 49-56°C
- Boiling point: 300-355°C
- Vapour pressure: at 25°C 1.19 x 10-3 Pa
- Water solubility (under test conditions): <1mg/L
- log Pow: 7.7
- Stability in water: 96h



OTHER PROPERTIES (if relevant for this endpoint)
- Results of test for ready biodegradability: readily biodegradable

Sampling and analysis

Analytical monitoring:

no

Test solutions

Vehicle:

no

Details on test solutions:

As the solubility lies below 100 mg/L, the water-accommodated fraction was prepared for the test. This was done by weighing the nominal load, adding the corresponding amount of dilution water and shaking vigorously for 24 hours. The resulting solution was filtrated through 0.45 µm filters.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna
- Strain: Berlin
- Source: Umweltbundesamt Berlin
- Age at study initiation (mean and range, SD): between 0 and 24hours
- Feeding during test
- Food type: none

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Post exposure observation period:

after 24hours and 48hours , the immobilised daphnia were counted.

Test conditions

Hardness:

2.50 mmol/L

Test temperature:

20+/-2°C

pH:

7.6 to 7.8

Dissolved oxygen:

between 9.7 and 10.1 mg/L

Nominal and measured concentrations:

Nominal concentrations tested are 1; 10; 100 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel:
glass beakers , nomminal volume 50ml, tall Shape, diameter 8mm
- Type of flow-through (e.g. peristaltic or proportional diluter):
- Renewal rate of test solution (frequency/flow rate):
- No. of organisms per vessel:five
- No. of vessels per concentration (replicates):4
- No. of vessels per control (replicates):4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:deionised water with an enrichment of certain minerals

OTHER TEST CONDITIONS
- Adjustment of pH: 7.8-+0.2

Reference substance (positive control):

yes

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

24 h

Dose descriptor:

NOEC

Effect conc.:

ca. 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

ca. 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 3

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 4

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Results with reference substance (positive control):

the 24h-EC50i of potassium dichromate was determined as 1.4mg/L, lying within the demanded range of 0.6 -2.1 mg/L.

Any other information on results incl. tables

All validity criteria were met . For the estimation of the EC50 of the reference item, the fit showed sufficient statistical correspondance of the data with the dose response equation. The 24h EC50i of potassium dichromate was determined as 1.4 mg/L , lying within the demanded range of 0.6 -2.1 mg/L.

As the test item is poorly water soluble, the "water accomodated fraction" was used for the test.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

24h-NOEC=100mg/L
48h-NOEC=100mg/L
24h-EC50i=>100mg/L
48h-EC50i=>100mg/L

Executive summary:

The study was performed in order to evaluate the toxic potential of the test product towards freswater shrimp, using the species Daphnia magna. Daphnia magna Straus, which belongs to the family of crustacea,was chosen in the guideline as a typical part of zoo-plancton.

As the test item is poorly water soluble, the "water accomodated fraction" was used for the test. this was done by weighing the nominal load, adding the corresponding amount of dilution water and shaking vigorously for 24 hours. the resulting solution was filtrated through 0.45 micrometer filters.

In the main study, three concentrations of the test item in a geometric series (spaced by factor 10, the highest being 100mg/L) were used. Twenty daphnia were exposed to the test item for 48 hours in a static test system. After 24 and 48 hours , the immobilised daphnia were counted.

No significant immobilisation was observed in the treatment and in the control groups. The 24h-EC50i of potassium dichromate was tested in a current reference test. The value was determined as 1.4mg/L, lying within the demanded range of 0.6 -2.1 mg/L.

The following results could be determined for the test item (species daphnia magna):

24h-NOEC=100mg/L

48h-NOEC=100mg/L

24h-EC50i=>100mg/L

48h-EC50i=>100mg/L