1,3-Propanediamine, N-[3-((C11-14, C13-rich)oxy)propyl]- branched acetate

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

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

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The results refer to technical product as received from the sponsor. The test is performed according to standard guidelines, under GLP, no chemical analyses. IPA is used as solvent, because the test substance is poorly soluble in water. One fish died in the control with IPA, this is not considered to have an impact on the test results, because in the two lowest test concentrations no fish died during the test. In one test vessel the oxygen concentration was just below 60% instead of >60%, this did not have an impact on the test results either, because no fish died in that aquarium and it happened only at 96h. The effects of the test compound seem normal.

Justification for type of information:

See section 13.2 for the read-across justification.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

and EU Method C.1 (Acute Toxicity for Fish)

GLP compliance:

yes

Analytical monitoring:

no

Vehicle:

yes

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Stock solutions were prepared in IPA due to the poor water solubility of the test substance. The test concentrations were prepared by addition of the respective amounts of stock solution in DSW.
- Controls: One control and one control with 100 uL IPA/L
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Isopropylalcohol
- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s)): the highest test concentration (0.22 mg/L) contained 100 ul IPA/L, therefore one control + 100 uL IPA/L was added.
- Evidence of undissolved material (e.g. precipitate, surface film, etc): -

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebra fish
- Strain: -
- Source: a well-known local aquarium retailer
- Age at study initiation (mean and range, SD): -
- Length at study initiation (length definition, mean, range and SD): 2.8 cm approx.
- Weight at study initiation (mean and range, SD): 0.3 g approx.
- Method of breeding: -
- Feeding during test: No feeding

ACCLIMATION
- Acclimation period: Before being used in the test, the fish were kept for at least 12 days in the laboratory
- Acclimation conditions (same as test or not): Holding water: Dutch Standard Water
- Type and amount of food: -
- Feeding frequency: 1 to 3 times a day during 6 days a week. Last feeding took place about 24 hours before the start of the test.
- Health during acclimation (any mortality observed): -

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Post exposure observation period:

The fish were kept for at least 12 days in the laboratory to determine the acceptability of the batch.

Hardness:

13 degree dH

Test temperature:

22.4 - 23.0 degree C

pH:

7.4 - 8.2

Dissolved oxygen:

8.2 - 8.3 mg O2/l at the start of the test
4.9 - 5.9 mg O2/l at the end of the test
At 0.069 mg/L the oxygen concentration went just below 60% of the saturation value at the end of the test. This is not considered to have an impact on the outcome of the test because no fish died at this test concentration.

Nominal and measured concentrations:

0.047, 0.069, 0.10, 0.15 and 0.22 mg/l (nominal)

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): open; covered with a glass plate
- Material, size, headspace, fill volume: 5 L glass aquaria
- Aeration: No
- Renewal rate of test solution (frequency/flow rate): solutions were renewed after 48 hours
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): 1
- Biomass loading rate: 0.7 g/L approx.


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Synthetic water (Dutch Standard Water)
- Total organic carbon: -
- Particulate matter: -
- Metals: -
- Pesticides: -
- Chlorine: -
- Alkalinity: -
- Ca/mg ratio: 100 mg/L NaHCO3, 20 mg/L KHCO3. 200 mg/L CaCl2*2H2O, 180 mg/L MgSO4*7H2O
- Conductivity: -
- Culture medium different from test medium: No
- Intervals of water quality measurement: -


OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 12 hours
- Light intensity: -


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mortality, behaviour, appearance


TEST CONCENTRATIONS
- Range finding study: Four range finding studies were performed
- Test concentrations:
First: 0.01, 0.1, 1.0 and 10 mg/L
Second: 0.022 and 0.046 mg/L
Third: 0.04, 0.05, 0.063, 0.079 and 0.1 mg/L
Fourth: 0.03, 0.07, 0.12 and 0.18 mg/L
- Results used to determine the conditions for the definitive study:
First: No mortality at 0.01 mg/L and all fish died within 4 hours at 0.1, 1.0 and 10 mg/L. This result was doubtful because very low amounts of a highly concentrated stock were used and the possibility of pipetting errors could not be ruled out.
Second: No mortality was observed at both concentrations within 92 hours.
Third: Only at 0.1 mg/L 70% of the fish died within 96 hours, in the other concentrations no mortality was observed.
Fourth: 100% mortality at 0.12 mg/L after 98 hours and at 0.18 mg/L after 17 hours. No mortality at 0,03 and 0.07 mg/L.

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

0.1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 95% Confidence limits 0.09 - 0.12 mg/L

Details on results:

- Behavioural abnormalities: At 0.10 mg/L one fish was floating upside down from 76 to 96 hours.
- Mortality of control: No mortaility in the control. In the control + IPA one fish was found dead after 44 hours.
- Other adverse effects control: No
- Abnormal responses: No

Results with reference substance (positive control):

- Results with reference substance valid?: yes
- Mortality: No mortality at 100 mg/L and the control, one fish died in 29 hours at 210 mg/L and at 460 mg/L all fish were found dead at 21 hours.
- LC50: -
- Other: One fish was floating upside down at 210 mg/L from 53 hours till the end of the test

Reported statistics and error estimates:

The LC50 was determined with an LC50 programme of Grifioen (RIZA) based on a model of Kooyman (1981).

Sublethal observations / clinical signs:

Number of surviving animals

concentration (mg/L)		0h	4h	20h	24h	28h	44h	48h	52h	68h	72h	76h	92h	96h
control		7	7	7	7	7	7	7	7	7	7	7	7	7
control + IPA		7	7	7	7	7	6	6	6	6	6	6	6	6
0.047		7	7	7	7	7	7	7	7	7	7	7	7	7
0.069		7	7	7	7	7	7	7	7	7	7	7	7	7
0.10		7	7	7	7	7	7	7	7	6	5*	5*	5*	5*
0.15		7	7	2	1	1	1	1	1	0
0.22		7	4	0

* one fish was almost dead, flaoting upside down

Validity criteria fulfilled:

yes

Remarks:

The oxygen level in one aquarium went just below 60% of the saturation value, but this is not considered to have an impact on the outcome of the test because no fish died at this concentration.

Conclusions:

LC50 = 0.1 mg/L (nominal)

Executive summary:

Duomeen T was tested in an acute toxicity test with Brachydanio rerio (zebra fish) under semi-static conditions in accordance with EEG
method C.1 (updated version 11/1989) and OECD Test Guideline 203 (draft updating 12/1989).
No chemical analyses of the test concentrations were performed during the test and all concentrations mentioned are nominal concentrations.
The LC50 (96 h) was calculated to be 0.1 mg/L with 95% confidence limits of 0.09 and 0.12 mg/L.
The highest concentration causing no mortality (no observed effect concentration, NOEC) after 96 hours amounted to 0.069 mg/l, whereas 100% mortality was produced within 68 hours at 0.15 mg/L.
Sublethal effects were observed at 0.10 mg/L.

Description of key information

Read across of the results of a 96 h fish test performed with long chained diamine was performed. This read across is based on the fact that no, or only minor, differences in the results of the acute fish toxicity tests, performed with cat ionic surfactants, has been observed.  

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 µg/L

Additional information

The results of the 96 h fish toxicity tests performed with substances within the primary fatty amines category shows a variation in LC50 between 100 and 1000 µg/L and it seems as the long chained substances in this category are slightly more toxic. The same narrow variation can be observed for substances in the diamine category with a variation of LC 50 between 100 and 500 µg/L. Moreover also for the diamines it seems as the short term toxicity to fish for the long chained diamines are slightly higher then for the short chained diamines. Also for the substances in the poly amine category the variation of the LC50 is in the same range between 100 and 500 µg/L, the substance with the lowest toxicity is the short chained branched triamine. All in all there are, in these three categories primary fatty amines, diamines and polyamines, approximately 15 toxicity tests performed with fish available and the LC50s are all in the same range 100 µg/L to 1000 µg/L. To be able to determine if there is a significant difference in toxicity between long chained diamine and etherdiamine the results from the long term toxicity to aquatic organisms, daphnia and algae, was compared. The NOEC determined in the 21 d daphnia test was 90 µg/L for etherdiamines and 100 µg/L for diamines, and for algae the EC10 was 184 µg/L for etherdiamines and 188 µg/L for diamines. It can be concluded that no difference in toxicity to aquatic organisms between etherdiamine and diamine can be observed in long term test, which supports the read across from diamine to etherdiamine. Moreover, there are data in the open litterature that states that the LC50 of etherdiamine in a 96 hour fish tests has been determined to between 100 and 300 µg/L. These sources are considered not to be reliable enough for using as a reference, but together with the data for other cationic categories there is a weight of evidence that the LC50 is above 100 µg/L.