Reaction products of N-lauroyl-L-glutamic acid with octyldodecanol and behenyl alcohol and beta-sitosterol and campesterol and stigmasterol

Toxicity to aquatic algae and cyanobacteria

Administrative data

Endpoint:

toxicity to aquatic algae and cyanobacteria

Type of information:

other: read-across based on grouping of substances (category approach)

Remarks:

none

Adequacy of study:

key study

Study period:

16.04.1999 to 23.04.1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 201 (Alga, Growth Inhibition Test)

Version / remarks:

(1984)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.3 (Algal Inhibition test)

Version / remarks:

(1992)

GLP compliance:

yes (incl. QA statement)

Remarks:

RCC Ltd, Itingen (Switzerland)

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report): Eldew PS-203
- Physical state: pale yellow, oily liquid
- Analytical purity: 100%
- Purity test date: not reported
- Lot/batch No.: 808010
- Expiration date of the lot/batch: 31.03.2000
- Storage condition of test material: test material was stored at room temperature (ca. 20°C), away from direct sunlight

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

Because of the large number of components in the test item, quantification of each individual component could not be performed, but the component of the main component was measured in the single WAF and the control. For the analytical determination duplicate samples from the freshly prepared WAF and the control were taken just before the start of the test. For the determination of the maintenance of the main component under the test conditions, requisite volumes of the freshly prepared WAF and the control were incubated during the test period under the same conditions as in the actual test (but without algae). From these flasks, duplicate samples were taken after the 72 h testing period. All samples were analysed immediately after sampling.
The mean concentrations found in the treatment samples were 0.119 mg/l (sampling day 0) and 0.120 mg/L (sampling day 3). The concentration of the main component was nearly constant during the test period.

Test solutions

Vehicle:

no

Details on test solutions:

A water accommodated fraction (WAF) was prepared (no auxiliary solvent or emulsifier was used) due to the properties of the test item (multi-component test item, containing sparingly soluble components). WAF with the loading rate of 100 mg/l was used as the only test medium (limit test): a saturated dispersion of the test item was prepared by mixing of the test item into the test water as homogeneously as possible by ultrasonic treatment and by intense stirring at room temperature in the dark for 96 hrs and filtration just before start of the test.

Test organisms

Test organisms (species):

Desmodesmus subspicatus (previous name: Scenedesmus subspicatus)

Details on test organisms:

TEST ORGANISM
- Common name: green algae
- Strain: 86.81 SAG
- Source (laboratory, culture collection): Sammlung von Algenkulturen, Pflanzenphysiologisches Institut der Universität Göttingen (Göttingen, Germany)
- Age of inoculum (at test initiation): 4 d
- Method of cultivation: according to guideline

ACCLIMATION:
- Acclimation period: not necessary
- Culturing media and conditions (same as test or not): same
- Any deformed or abnormal cells observed: no

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

72 h

Test conditions

Hardness:

24 mg CaCO3/L

Test temperature:

22-23°C

pH:

at the start: 7.9-8.0
at the end: 8.9

Nominal and measured concentrations:

100 mg/L nominal
0.119 -0120 mg/L measured

Details on test conditions:

TEST SYSTEM
- Test vessel: Erlenmeyer flasks
- Type (delete if not applicable): the flasks were covered with glass dishes
- Material, size, headspace, fill volume: glass/50 mL/35 mL/15 mL
- Aeration: not reported
- Type of flow-through (e.g. peristaltic or proportional diluter): test conducted under static conditions
- Initial cells density: 10000 cells/mL
- Control end cells density: 1041600 cells/mL
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 6

GROWTH MEDIUM
- Standard medium used: yes

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: synthetic test water according to guideline
- Culture medium different from test medium: no
- Intervals of water quality measurement: The pH values were measured in samples from the single WAF and the control at the start and end of the test. The water temperature was measured at least daily.

OTHER TEST CONDITIONS
- Sterile test conditions: not reported
- Adjustment of pH: no
- Photoperiod: continuous illumination
- Light intensity and quality: 6800-7500 Lux (fluorescent tubes)

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : biomass and growth rate
- Determination of cell concentrations: electronic particle counter

TEST CONCENTRATIONS
- Spacing factor for test concentrations: not applicable (limit test)
- Justification for using less concentrations than requested by guideline: limit test
- Range finding study: performed
- Test concentrations: not reported
- Results used to determine the conditions for the definitive study: yes

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

72 h

Dose descriptor:

EL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

biomass

Effect concentrations 2

Duration:

72 h

Dose descriptor:

EL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth rate

Effect concentrations 3

Duration:

72 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth rate

Effect concentrations 4

Duration:

72 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Basis for effect:

biomass

Reported statistics and error estimates:

Student-t-test

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The test item had no inhibitory effect on growth of Scenedesmus subspicatus during the exposure period of 72 h at a loading rate of 100 mg/L nominal (72 NOEC>=100 mg/L nominal; 72 h EL50>100 mg/L nominal)).