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

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1999-02-11 to 1999-11-09

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

adopted My 17, 1992

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Version / remarks:

dated December 29, 1992

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test)

Version / remarks:

April ! 996

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

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 400 mg of the test substance into 4 L 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 70 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):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebra fish
- Age at study initiation: Juveniles
- Length at study initiation (mean): 3.27 ± 0.21 cm
- Weight at study initiation (mean): 0.35 ± 0.07 g
- holding conditions: The fish were held in test water in the laboratories of IBACON for 6 weeks prior to the start of the test without any medication. During holding until one day before test start the fish were fed with a commercial fish diet (TETRA MM Hauptfutter, TETRA-Werke, 49324 Melle, Germany). During the last 6 weeks prior to the test no fish died in the test fish batch and all fish were healthy.
- Feeding during test: None

ACCLIMATION
- Acclimation period: During the 7 weeks before the start of the test the fish were acclimated to the test temperature.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

250 mg CaCO3/L

Test temperature:

21 - 22 °C

pH:

7.6 to 7.8

Dissolved oxygen:

At least 7.6 mg/L

Nominal and measured concentrations:

Nominal: 100 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 9 L glass aquaria with 3.5 L test medium
- Aeration: The test media were slightly aerated during the test
- No. of organisms per vessel: 7


TEST MEDIUM / WATER PARAMETERS: according to the guideline


OTHER TEST CONDITIONS
- Photoperiod: 16 h light: 8 h dark
- Light intensity: 208 - 236 lux

EFFECT PARAMETERS MEASURED:
Mortality and Symptoms of Intoxication: The test fish were observed after approximately 2, 24, 48, 72 and 96 hours test duration.
Measurement of pH, dissolved Oxygen and Water Temperature: determined daily in the test media of all test concentrations and the control.
Behaviour of the Test Substance in Test Water: The behaviour of the test substance in all test concentrations was determined once every day during the test.

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

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.

Reported statistics and error estimates:

The NOEC and the LC 0 were determined directly from the raw data. The LOEC, the LC 50 and the LC 100 could not be quantified due to the absence of toxicity of the test substance up to the tested concentration.

Validity criteria fulfilled:

yes

Conclusions:

The test item was tested for acute toxicity to freshwater fish in a 96 h-static test according to EU method C.1. The ecotoxicity data indicates the substance is not toxic to fish up to the limit of its solubility.

Executive summary:

The test substance was assessed in a short-term toxicity study to fish according to EU method C.1 and OECD guideline 203. The definitive studies were conducted on the filtrate of a super saturated stock suspension of the substance at a nominal concentration of 100 mg/L. The results of the definitive study showed that no mortalities were observed at this substance concentration. The 96-hour NOEC of the substance to Zebra fish was determined to be >= 100 mg/L. The 96-hour LC 50 and the 96-hour LC 100 were > 100 mg/L.

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reason / purpose for cross-reference:

read-across source

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Description of key information

The read-across substance was assessed in a short-term toxicity study to fish according to EU method C.1 and OECD guideline 203. The 96-hour NOEC of the read-across substance to Zebra fish was determined to be >= 100 mg/L. The 96-hour LC 50 and the 96-hour LC 100 were > 100 mg/L.

 

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L

Additional information

The read-across substance was assessed in a short-term toxicity study to fish according to EU method C.1 and OECD guideline 203. The definitive studies were conducted on the filtrate of a super saturated stock suspension of the read-across substance at a nominal concentration of 100 mg/L. The results of the definitive study showed that no mortalities were observed at this read-across substance concentration. The 96-hour NOEC of the read-across substance to Zebra fish was determined to be >= 100 mg/L. The 96-hour LC 50 and the 96-hour LC 100 were > 100 mg/L.