Reaction products of behenic acid, Eicosadioic acid and Polyglyceryl-10

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23. January - 05. June 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Name Nomcort HK-P
Batch no. 7-4-C
Appearance white/pale yellow waxy solid
Composition Polyglyceryl-10 Behenate / Eicosadioate
CAS No. 457632-32-5
EINECS-No. 478-920-0
Purity 100%
Homogeneity homogeneous
Volatility 0.00000001 hPa (20°C)
Stability H2O: unknown; EtOH: unknown; acetone: unknown; CH3CN: unknown; DMSO: unknown
Solubility H2O: 0.1-1 g/L; EtOH: unknown; acetone: unknown; CH3CN: unknown; DMSO: unknown
Production date 17. Apr. 2017
Expiry date 17. Apr. 2020
Storage Room Temperature (20 ± 5°C)

Analytical monitoring:

yes

Details on sampling:

The DOC content of the test item in the test vessels was measured at the beginning and at the end of the test.

Vehicle:

no

Details on test solutions:

Dilution water (Daphnia medium) with the following specification is used

Parameter Concentration in mg/L
CaCl2*2H2O 293.80
MgSO4*7H2O 123.30
NaHCO3 64.80
KCl 5.80
Resulting hardness in mmol/L: 2.502
Resulting hardness in mg CaCO3/L: 250
Deviations from the nominal weighted loads were less than 5%. Exact values ae recorded in the raw data. After preparation, the dilution water was aerated and the pH was meas-ured. The pH was 7.8.

Test organisms (species):

Daphnia magna

Details on test organisms:

Species Daphnia magna
Authority STRAUS
Strain Berlin
Sex female
Age between 0 and 24 hours
Origin Umweltbundesamt Berlin
In-house breeding since 27. September 2007
Selection of the test system was made following the proposal of the guidelines.
Daphnia magna is bred in the LAUS GmbH throughout the year. The animals are kept for the use in toxicity tests. They multiply by parthenogenesis, thus being genetically identical. The husbandry is performed similar to the method described in the OECD guideline, following SOP 115 002 01 („Zucht und Hälterung von Daphnia magna STRAUS“), Version 12 from 02. Feb. 2015.
Vessels preserving glasses, nominal volume 2 L
Medium M4-Medium (recipe of ELENDT)
Food unicellular green algae (Desmodesmus subspicatus)
Medium renewal twice a week
Photo period 16/8 hours, using neon tubes
Temperature 20  2 °C

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Post exposure observation period:

none

Hardness:

250 mg CaCO3 /L

Test temperature:

19.7 - 21.2°C

pH:

7.6-7.7

Dissolved oxygen:

8.5 - 9.1 mg/L

Salinity:

not stated

Conductivity:

not stated

Nominal and measured concentrations:

100 mg/L nominal, 17.3 mg/L measured (geometric mean)

Details on test conditions:

Date of performance 30. Jan. – 01. Feb. 2018
Treatments 100 mg/L
Temperature 19.7 - 21.2°C
Duration 48 hours
Observation times 24 and 48 hours
Medium renewal none
Test vessels glass beakers, nominal volume 50 mL, tall shape
Replicates (Treatments) 4 vessels, each containing 20 ± 5 mL test solution and 5 Daphnia
Replicates (Blank control) 4 vessels, each containing 20 ± 5 mL dilution water and 5 Daphnia

Reference substance (positive control):

yes

Key result

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Key result

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

>= 17.3 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Results with reference substance (positive control):

Potassium dichromate K2Cr2O7 (CAS No. 7778-50-9) was used as positive control in a current reference study (201701R201). The 24h-EC50 value was determined as 1.6 mg/L. The value was within the requested range for the 24h-EC50 between 0.6 - 2.1 mg/L of po-tassium dichromate K2Cr2O7 as specified in the OECD guideline. Since the fits showed sufficient statistical correspondence of the data with the dose-response-equation, this reference study can be considered valid.

Reported statistics and error estimates:

no statistic or error estimates reported

Validity criteria fulfilled:

yes

Conclusions:

No effect on aquatic invertebrates was noted for Nomcort HK-P under the reported test conditions.

Executive summary:

One valid experiment was performed.

The study was performed as a limit test using 1 concentration at 100 mg/L (nominal). For each test concentration, 20 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.

After 48h none of the animals was immobilised in the blank control and at 100 mg/L.

Potassium dichromate K₂Cr₂O₇(CAS No. 7778-50-9) was used as positive controlin a current reference study to assure that the test conditions are reliable.

 

At the start and at the end of the test, the content of the test item in the test solutions was determined using measurement of dissolved organic carbon (DOC). The measured concentration based on TOC measurement was 15% of the nominal concentration at the beginning of the test and 20% of the nominal concentration at the end of the test. Therefore, the determination of the results was based on the geometric mean of the measured concentrations.

The following results were determined for the test itemNomcort HK-P(species:Daphnia magna).

	Nominal concentration	Geometric mean of measured concentration
48h-NOEC	≥100 mg/L	≥17.3 mg/L
48h-LOEC	> 100 mg/L	> 17.3 mg/L

 

 

Description of key information

One Guideline study available

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

100 mg/L

Additional information

A NOEC of 100 mg/L was found. To perform a chemical safety assessment, this value is used above