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

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

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

Adequacy of study:

key study

Study period:

14.04.1999 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 203 (Fish, Acute Toxicity Test)

Version / remarks:

(1992)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

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, duplicate samples from the test medium and the control were taken after 48 h and at the end of the test (96 h). All samples were taken from the approximate center of the aquaria without mixing of the test media, and were analysed immediately after sampling.
The mean concentrations found in the treatment samples were 0.169 mg/l (sampling day 0), 0.133 mg/l (sampling day 2) and 0.089 mg/l (sampling day 4). The losses could be due to adsorption of the test item or due to precipitation of fine-particulate material of the test item.

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 72 hrs and filtration just before start of the test.

Test organisms

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: zebra fish
- Source: fish were obtained from Zoohaus Schaub, Liestal (Switzerland)
- Age at study initiation (mean and range, SD): not reported
- Length at study initiation (length definition, mean, range and SD): 3.1 +/- 0.1 cm (mean)
- Weight at study initiation (mean and range, SD): 0.37 +/- 0.04 g (mean)
- Method of breeding: not reported
- Feeding during test: no

ACCLIMATION
- Acclimation period: one week
- Acclimation conditions (same as test or not): same
- Type and amount of food: TETRA MIN (amount of food not reported)
- Feeding frequency: not reported
- Health during acclimation (any mortality observed): yes

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test conditions

Hardness:

250 mg CaCO3/L

Test temperature:

21°C

pH:

7.8 - 8.0

Dissolved oxygen:

>=8.0 mg/L

Nominal and measured concentrations:

100 mg/L nominal
0.169 mg/L (sampling day 0), 0.133 mg/L (sampling day 2) and 0.089 mg/L (sampling day 4) (measured)

Details on test conditions:

TEST SYSTEM
- Test vessel: glass aquaria
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: glass/4 L/0/4 L
- Aeration: the test media were slightly aerated during the test period
- Type of flow-through (e.g. peristaltic or proportional diluter): test conducted under static conditions
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: ca. 0.65 g/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: according to guideline
- Culture medium different from test medium: the fish were acclimatized to test conditions for 7 d
- Intervals of water quality measurement: water temperature, pH and dissolved oxygen concentrations were measured once every day during the test

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light/8 h dark
- Light intensity: not reported

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

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

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

24 h

Dose descriptor:

LL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 2

Duration:

48 h

Dose descriptor:

LL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 3

Duration:

72 h

Dose descriptor:

LL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 4

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 5

Duration:

96 h

Dose descriptor:

LL100

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 6

Duration:

96 h

Dose descriptor:

LL0

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: mortality and behaviour

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

No mortality or other signs of intoxication were determined during the test period of 96 hrs. The 96-hr NOEL and the 96-hr LLO were determined to be >=100 mg/L. The 96 h LL50 was determined to be > 100 mg/L (values refer to nominal concentrations)