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

Toxicity to aquatic algae and cyanobacteria

Administrative data

Endpoint:

toxicity to aquatic algae and cyanobacteria

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 201 (Alga, Growth Inhibition Test)

GLP compliance:

yes (incl. QA statement)

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of test material (as cited in study report): MONTANOV 68
- Physical state: pearls of wax
- Analytical purity: > 99%
- Composition of test material, percentage of components: cetearyl alcohol about 80%; cetearyl glucoside about 20%
- Lot/batch No.: T62615
- Expiration date of the lot/batch: 08.06.2007 (re-test)
- Stability under test conditions: water 96 hours
- Storage condition of test material: room temperature 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: 195.5°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

OTHER PROPERTIES (if relevant for this endpoint)
- Results of test for ready biodegradability: 97.38% in 28 days at 20mg/L

Sampling and analysis

Analytical monitoring:

yes

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. After membrane filtration, the solutions were used to prepare the product dilutions. Since the solutions were diluted by algal pre-culture and nutrient medium, 1.25 times the nominal amount was used in preparation of the water-accommodated fractions.

Test organisms

Test organisms (species):

Desmodesmus subspicatus (previous name: Scenedesmus subspicatus)

Details on test organisms:

TEST ORGANISM
- Common name: desmodesmus subspicatus
- Strain: Chodat
- Source and culture media (laboratory, culture collection): the culture of Desmodesmus subspicatus was obtained in October 2006 from the "collection of Alga", institu fur Pflanzenphysiologie of Universitat Gottingen. the Alga are kept as stock culture on solid agar at 8°C. from an aliquot of this culture , the pre-culture was prepared.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

72 h

Test conditions

Test temperature:

21-24°C

pH:

8.1-10

Nominal and measured concentrations:

0-1-10-100mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: round cuvette d=6mm
- No. of vessels per concentration (replicates):3 for each treatment
- No. of vessels per control (replicates):6

GROWTH MEDIUM
- Standard medium used: yes

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: freswater

OTHER TEST CONDITIONS
- Sterile test conditions: yes
- Light intensity and quality: 4440-8880 Lux


TEST CONCENTRATIONS
- Spacing factor for test concentrations:
- Justification for using less concentrations than requested by guideline:
- Range finding study
- Test concentrations:
- Results used to determine the conditions for the definitive study:

Reference substance (positive control):

yes

Remarks:

potassium dichromate CAS number 7778-50-9

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

72 h

Dose descriptor:

LOEC

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth rate

Effect concentrations 2

Duration:

72 h

Dose descriptor:

LOEC

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

biomass

Effect concentrations 3

Duration:

72 h

Dose descriptor:

LOEC

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

cell number

Effect concentrations 4

Duration:

72 h

Dose descriptor:

NOEC

Effect conc.:

ca. 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

biomass

Effect concentrations 5

Duration:

72 h

Dose descriptor:

NOEC

Effect conc.:

ca. 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth rate

Effect concentrations 6

Duration:

72 h

Dose descriptor:

NOEC

Effect conc.:

ca. 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

cell number

Effect concentrations 7

Duration:

72 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Results with reference substance (positive control):

The EC50s of potassium dichromate was tested in a current reference test. For the estimation of the EC50s of the reference idem, the fits showed sufficient statistical correspondence of the data with the dose-response-equation, the resulting values lay within the normal range of the laboratory.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The following results for the test item were determined:

72h NOEC (Growth rate) = 100mg/L
72h NOEC (AUC) = 100mg/L
72h NOEC (Yield) = 100mg/L

72h LOEC (growth rate) >100mg/L
72h LOEC (AUC) >100mg/L
72h LOEC (Yield) >100mg/L

72h ErC50>100mg/L
72h EbC50>100mg/L
72h EyC50>100mg/L

Executive summary:

As the test item is poorly soluble in water, the water accomodated fraction was tested.This was done by shaking the nominal load with the appropriate amount of deionised water for 24 hours, followed by membrane filtration. In the main study, three concentrations of the test item in a geometric series (espaced by factor 10, the highest being 100mg/L) were used. The treatments were used to incubate the unicellular freshwater green alga Desmodesmus Subspicatusfor a period of 72 hours.The cell concentration of each replicate was determined by measuring the absorption of the cuvettes at 440 nm every 24 hours with a spectral photometer. with these measured values, the number of cells was calculated (linear correlation between cell concentration and absorption given). then the growth rate, the area under the growth curve (AUC1) and the yield 2 could be determined. the EC 50s of potassium dichromate was tested in a current reference test. the values lay within the normal range of laboratory. The following results for the test item were determined:

72h NOEC (Growth rate) = 100mg/L

72h NOEC (AUC) = 100mg/L

72h NOEC (Yield) = 100mg/L

72h LOEC (growth rate) >100mg/L

72h LOEC (AUC) >100mg/L

72h LOEC (Yield) >100mg/L

72h ErC50>100mg/L

72h EbC50>100mg/L

72h EyC50>100mg/L