Reaction mixture of hydrogenated tallow alkyl amines with sebacic acid and lithium hydroxide

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:

1999-09-22 to 1999-11-09

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Version / remarks:

dated December 29, 1992

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

adopted April 04, 1984

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 850.1010 (Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids)

Version / remarks:

April 1996

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Vehicle:

no

Details on test solutions:

A supersaturated stock suspension of the test substance with a nominal concentration of 100 mg/L was prepared by dosing 50 mg of the test substance into 500 mL test water. No auxiliary solvent or emulsifier was used. The test substance was mixed into the test water as homogeneously as possible by ultrasonic treatment for 15 minutes and intense stirring. The supersaturated stock suspension was stirred on a magnetic stirrer at room temperature in the dark over 48 hours to dissolve, respectively disperse a maximum concentration of the test substance in the stock suspension.
The stock suspension of the test substance was filtered through a cellulose-nitrate filter with a defined pore size of 0.2 µm just before the start of the test.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Strain: Clone 5
- Sex: female
- Source: supplied 1997 by the Umweltbundesamt, Institut für Wasser-, Boden- und Lufthygiene, Berlin, Germany
- Age at study initiation: 6.5-22 hours old
- Method of breeding: The Daphnia were bred in the laboratories of IBACON under similar temperature and light conditions as in the test, and In reconstituted water of a similar quality regarding to pH, components of the main ions and total hardness as the test water used in the test. The test organisms were not first brood progeny.


ACCLIMATION
- Acclimation period: for approximately 7 hours under test conditions

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

250 mg CaCO3/L

Test temperature:

21 °C

pH:

7.6 to 7.8

Dissolved oxygen:

at least 7.6 mg/L or higher

Nominal and measured concentrations:

Nominal: 100 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: glass beakers of 100 mL volume with 50 mL test medium
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2 daphnia
- No. of vessels per control (replicates): 2 daphnia


TEST MEDIUM / WATER PARAMETERS: according to the guideline

OTHER TEST CONDITIONS
- Photoperiod: 16 h light: 8 h dark
- Light intensity: 590 lux

EFFECT PARAMETERS MEASURED:
Mortality: The immobility or mortality of the Daphnia was determined by visual controls after 24 and 48 hours.
Measurement of pH, dissolved Oxygen and Water Temperature: At test start and end the pH-values and the dissolved oxygen concentrations were determined in the test medium of the only test concentration and the control. At the same times the water temperature was determined in one control beaker.
Behaviour of the Test Substance in Test Water: The behaviour of the test substance in test water was determined at the start of the test, after 24 and 48 hours test duration in the undiluted filtrate.

Duration:

48 h

Dose descriptor:

EC0

Effect conc.:

> 100 mg/L

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Duration:

48 h

Dose descriptor:

EC100

Effect conc.:

> 100 mg/L

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

> 100 mg/L

Details on results:

Due to the low water solubility limit no analytical dose verification could be done in the present test. Therefore, the biological results are related to the solubility limit of the test substance in the test medium.

Validity criteria fulfilled:

yes

Conclusions:

The test substance (EC: 433-100-1) was tested for toxicity to aquatic freshwater invertebrates in a 48 h-static test according to EU method C.2 and OECD guideline 202. The ecotoxicity data indicates the test substance is not toxic to daphnia up to the limit of its solubility.

Executive summary:

The test substance (EC: 433-100-1) was assessed in a short-term toxicity to aquatic invertebrates study according to EU-method C.2 and OECD guideline 202. The definitive studies were conducted on the filtrate of a super saturated stock suspension of the test substance at a nominal concentration of 100 mg/L. The immobilisation tests with daphnia were performed in duplicate using 10 daphnids per flask with observations performed at 24 and 48 hours. The 48-hour NOEC to Daphnia magna were determined to be >= 100 mg/L. The 48-hour EC 50 and EC 100 were > 100 mg/L.

Description of key information

The test substance (EC: 433-100-1) was assessed in a short-term toxicity to aquatic invertebrates study according to EU-method C.2 and OECD guideline 202. The definitive studies were conducted on the filtrate of a super saturated stock suspension of the test substance at a nominal concentration of 100 mg/L. The immobilisation tests with daphnia were performed in duplicate using 10 daphnids per flask with observations performed at 24 and 48 hours. The 48-hour NOEC to Daphnia magna were determined to be >= 100 mg/L. The 48-hour EC 50 and EC 100 were > 100 mg/L.

 

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

100 mg/L

Additional information

The test substance (EC: 433-100-1) was assessed in a short-term toxicity to aquatic invertebrates study according to EU-method C.2 and OECD guideline 202. The definitive studies were conducted on the filtrate of a super saturated stock suspension of the test substance at a nominal concentration of 100 mg/L. The immobilisation tests with daphnia were performed in duplicate using 10 daphnids per flask with observations performed at 24 and 48 hours. The 48-hour NOEC to Daphnia magna were determined to be >= 100 mg/L. The 48-hour EC 50 and EC 100 were > 100 mg/L.