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

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

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

Adequacy of study:

key study

Study period:

29.03.1999 to 06.04.1999

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 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

(1984)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

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 separately (without daphnids) but under identical conditions as in the actual test. From this test medium and the control duplicate samples were taken after 48 h testing period. All samples were analysed immediately after sampling.
The mean concentrations found in the treatment samples were 0.74 mg/l (sampling day 0) and 0.73 mg/L (sampling day 2). 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):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Strain: clone 5
- Source: originally supplied by the University of Sheffield (UK) in 1992; since then the water flea is bred in the RCC laboratories
- Age at study initiation (mean and range, SD): 6-24 h
- Method of breeding: The daphnids were bred in reconstituted water of identical quality and under identical temperature and light conditions as in the test
- Feeding during test: no

ACCLIMATION
- Acclimation period: not necessary
- Acclimation conditions (same as test or not): same

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test conditions

Hardness:

250 mg CaCO3/L

Test temperature:

20-21°C

pH:

8

Dissolved oxygen:

>= 8.3 mg/L

Nominal and measured concentrations:

100 mg/L (nominal)
ca. 0.74 mg/L (measured)

Details on test conditions:

TEST SYSTEM
- Test vessel: 100 mL glass beaker
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: glass/100 mL/50 mL/50 mL
- Aeration: no
- Type of flow-through (e.g. peristaltic or proportional diluter): test conducted under static conditions
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: according to guideline
- Alkalinity: 0.8 mmol/L
- Ca/Mg ratio: 4:1
- Culture medium different from test medium: no
- Intervals of water quality measurement: At the start and at the end of the test, the pH-values, the oxygen concentrations and the water temperature were determined in the single WAF and the control

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light/8 h dark
- Light intensity: 200-1200 Lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : immobilisation

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:

24 h

Dose descriptor:

EL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Duration:

48 h

Dose descriptor:

EL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 3

Duration:

48 h

Dose descriptor:

EL100

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:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

In the WAF with the loading rate of 100 mg/L (nominal) no immobilized or dead test organisms or other signs of intoxication were determined during the test period of 48 h (48 h NOEC>=100 mg/L nominal, 48 h EL50>100 mg/L nominal).