Alkanol reaction products with bis(aminoalkyl(C=1~6))carbomonocycle, alkoxy(C=3~8)alkanol(C=2~7) and 2,4-TDI

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2017-07-20 to 2017-09-28

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

yes

Remarks:

No analytical determination of the test item was performed. According to the information of the sponsor, the test item is insoluble in water. Therefore, the water accommodated fraction (WAF) was the method of preparation of the test solutions.

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

The water-accommodated fraction was prepared for the test. This was done by weighing the nominal load 100 mg/L, (real load 100.0 mg/L) adding the corresponding amount of dilution water and shaking vigorously for 24 hours. The resulting solution was filtrated through 0.45 µm Cellulose ester filters.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

Species Danio rerio HAMILTON-BUCHANAN
Age sexually immature young fish, length 2 +- 1 cm
The animals were obtained from a commercial supplier. Before being used for the test, the fish were kept for at least 12 days under test conditions. During 7 days, mortality didn’t surpass 5 %.
Supplier: Dehner Garten Center, 67433 Neustadt
Date of arrival: 03. May 2017

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test temperature:

0h: 23.6 °C
24h: 23.4 °C
48h: 22.9 °C
96h: 23.1 °C

pH:

Control: 8.1 (0h), 8.1 (24h), 8.1 (48h), 8.1 (72h), 8.0 (96h)
Test item: 8.1 (0h), 8.1 (24h), 8.1 (48h), 8.1 (72h), 8.1 (96h)

Dissolved oxygen:

Control: 8.8 mg/L (0h), 8.2 (24h), 8.1 (48h), 8.3 (72h), 8.1 (96h)
Test item: 8.6 mg/L (0h), 8.2 (24h), 8.1 (48h), 8.3 (72h), 8.1 (96h)

Nominal and measured concentrations:

Nominal: 0 (Control), 100 mg/L

Details on test conditions:

24 hours before the start of the test, the test fish were no longer fed.
Date: 31. Jul. – 04. Aug. 2017
Treatments 100 mg/L
Test Design static
Medium renewal none
Duration 96 hours
Loading 1 fish/L
Vessels: glass aquaria, maximal volume 10 L
Aeration: accomplished with glass tubes
Feeding: none
Photo period: 12/12 hours using neon tubes
Temperature: 22.9 – 23.6 °C (deviation within on test +- 1 °C)
pH adjustment: none
Replicate (Treatments): 1 vessel, each containing 7 L test solution and 7 fish
Replicate (Blank Control): 1 vessel, containing 7 L tap water and 7 fish

Observations were made every 24 hours, measuring pH and O2-concentration of the test solution in each vessel and documenting mortalities or abnormal behaviour.

Vessels polyethylene aquaria
Medium chlorine-free tap water
Feeding three times a day with warmwater fish food, totalling about 1-2% of body weight per day
Photo period 12/12 hours, using neon tubes
Temperature 23 +- 2 °C

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)

Remarks on result:

other: No effects up to the limit of solubility

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: No effects up to the limit of solubility

Sublethal observations / clinical signs:

 Mortality

The mortalities were recorded daily and can be found in the following table.

Nominal Concentration in mg/L	Total number of fish used	Number of dead fish
		24 h	48 h	72 h	96 h
Blank control	7	0	0	0	0
100	7	0	0	0	0

 

No abnormal behaviour of the surviving fish was observed.

Results

The biological results of the test item are presented in the following table:

Parameter	Value
NOEC	=100 mg/L
LOEC	> 100 mg/L
96h LC50	> 100 mg/L

Validity criteria fulfilled:

yes

Conclusions:

The toxicity to Danio rerio was tested using a static test design.
The study was performed as a limit test at the nominal concentration 100 mg/L. Neither in the treatment nor in the control could any mortality be observed.
No observations were made which might cause doubts concerning the validity of the study outcome. All validity criteria were met.
The result of the test is considered valid.

Executive summary:

The toxicity to Danio rerio was tested using a static test design.

 

The study was performed using 1 concentration containing 100 mg/L nominal concentration. The concentration showed no significant mortality.

The following results for the test item could be determined:

96h-NOEC = 100 mg/L
96h-LOEC > 100 mg/L
96h-EC50 > 100 mg/L

 

The study met the validity criteria specified in the test guideline, as follows:

 

¨            The mortality in the blank control may not exceed 1 fish at the end of the test.
No mortality occurred in the blank control.

¨            The dissolved oxygen concentration must be at least 60% throughout the test.
The concentration of dissolved oxygen was at least 8.1 mg/L or 95 % throughout the test.

¨            The pH-value in the test solutions should not vary by more than 1 unit during the test.

The highest variation was 0.1 unit.

Description of key information

The acute toxicity of the test item to fish was tested in an experiment performed according to the OECD Test Guideline 203 and to GLP requirements.

The 96 LL50 was determined to be above the only concentration tested (100 mg/L) - no effects were observed up to the limit of solubility.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L