2-Propanol, 1-amino-, compds. with polyethylene glycol hydrogen sulfate C12-14-alkyl ethers

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:

10 NOV - 14 NOV 1994

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

- Sampling method: samples were taken from the intake line of the test tank

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A stock solution was prepared by adding 52.5 g test substance to 5 L deionised water. The stock solution was diluted with dionised water to give the respective test concentrations.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: zebra fish
- Source: West Aquarium, Bad Lauterberg, Germany
- Length at study initiation (mean, SD): 3 cm +/- 0.5 cm
- Weight at study initiation (mean): approximately 0.26 g
- Feeding during test: none



ACCLIMATION
- Acclimation period: 14 days
- Acclimation conditions (same as test or not): maintained in dechlorinated drinking water in 200 L tanks of in 300 L glass tanks at 20 +/- 2 °C with continuous flow.
- Type and amount of food: Trouvit at an amount of approximately 1% of body weight
- Feeding frequency: daily
- Health during acclimation (any mortality observed): the mortality was 7 days before the test start <= 5%

Test type:

flow-through

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

approximately 11 °dH

Test temperature:

20 °C - 23 °C

pH:

8.1 - 8.2

Dissolved oxygen:

90% - 103%

Nominal and measured concentrations:

Nominal concentration: 2.1, 3.5, 6.0, 10.0 and 17.0 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 45 L tanks
- Aeration: continuous in the test tanks
- Renewal rate of test solution (frequency/flow rate): flow rate: 10 L/h
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1



TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: drinking water (Gelsenwasser AG)


OTHER TEST CONDITIONS
- Photoperiod: 16 h light / 8 h darkness

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

7.7 mg/L

95% CI:

>= 6 - <= 10

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Sublethal observations / clinical signs:

Table 1: cumulative mortality

Concentration [mg/L]	Test period (h)
	24 h	48 h	72 h	96 h
	Mortality [%]	Mortality [%]	Mortality [%]	Mortality [%]
Control	0	0	0	0
2.1	0	0	0	0
3.5	0	0	0	0
6.0	0	0	0	0
10.0	100	100	100	100
17.0	100	100	100	100

Table 2 Analyticall determined test concentrations

Nominal concentration [mg/L]	0 h  [mg/L]	24 h  [mg/L]	48 h  [mg/L]	72 h  [mg/L]	96 h  [mg/L]	Concentration for biological valuation [mg/L]
2.1	3.26	2.31	1.68	1.47	1.58	2.1
3.5	5.88	3.36	2.94	2.63	2.31	3.5
6.0	9.14	5.46	4.83	3.26	5.15	6.0
10.0	11.6	16.8	--	--	--	10.0
17.0	15.8	16.8	--	--	--	17.0

-- not determined because all test animals were dead.

Table 3: Validity criteria for OECD 203 (2019)

Criterion from the guideline	Outcome	Validity criterion met
The mortality in the control(s) should not exceed 10% (or one fish if less than ten are used) at the end of the test	0%	yes
The dissolved oxygen concentration must have been at least 60 per cent of the air saturation value throughout the test	90% - 103%	yes
There must be evidence that the concentration of the substance being tested has been satisfactorily maintained, and preferably it should be at least 80% of the nominal concentration throughout the test. If the deviation from the nominal concentration is greater than 20 per cent, results should be based on the measured concentration.	>80% (MBAS assay)	yes

Validity criteria fulfilled:

yes

Remarks:

Please refer to table 3 in "Any other information on results incl. tables"

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

(e.g. non-GLP, no analytical monitoring)

Qualifier:

according to guideline

Guideline:

other: German industrial standard test guideline DIN 38412 part 15

GLP compliance:

no

Analytical monitoring:

no

Details on test solutions:

Dilution water source: Reconstituted freshwater according to DIN 38412, Part II, 1982
The product was added to the test water without any pretreamtent (subsequently the fish were placed into the aquaria).

Test organisms (species):

Leuciscus idus

Details on test organisms:

Test fish: Leuciscus idus (golden variety)
Supplier: Fischzucht Paul Eggers, 2354 Hohenwestedt, Germany
Body length: 5.7 cm (range 5.3 - 6.3 cm)
Body weight: 2.8 g (range 2.2 - 3.9 g)
Loading rate (g fish/L test water): 2.8
Medical treatment: twice with 0.05 mg/L malachite green chloride, once with 10 mg/L tetracycline hydrochloride

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

2.5 mmol/L

Test temperature:

19 - 20 °C

pH:

8.0 - 10.7

Dissolved oxygen:

7.8 - 8.9 mg/L

Nominal and measured concentrations:

Nominal test concentrations: 0 (control), 100, 215, 464 and 1000 mg/L. The highest test concentration (1000 mg/L) was also tested after pH-adjustment.

Details on test conditions:

Test vessels: All glass aquaria (30 x 22 x 24 cm)
Volume of water: 10 L
Continuous aeration with oil-free air, slight
Photoperiod: 16 : 8 hours day-night regime
One test vessel per treatment
No. of animals per test concentration and control: 10
Duration of adaption: about 6 weeks
Adaption to test water and test temperature: 3 days
Mortality during the adaption period: 0%
Withdrawal of food: 1 day before and during exposure.
Observations: mortality and symptoms after 1, 4, 24, 48, 72, and 96 h
Measurements: pH and oxygen content after 0, 24, 48, 72 and 96 h

Reference substance (positive control):

not specified

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

>= 215 - <= 464 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

not neutralized

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

neutralized

Sublethal observations / clinical signs:

No analytical dose-verification of the test item was carried out.

LC 50 (48h):    > 215 < 464 mg/l
LC 50 (72h):    > 215 < 464 mg/l
LC 50 (96h):    > 215 < 464 mg/l

Biological observations:
Symptoms of intoxication: A: apathy

NOEC = 100 mg/L

Cumulative mortality

Nominal conc.(mg/l)	Mortality (cumulated) after
	1 h	4 h	24 h	48 h	72 h	96 h
0	0	0	0	0	0	0
100	0	0	0	0	0	0
215	0	0	1	1	1	1
464	0	0	10	10	10	10
1000	10	10	10	10	10	10
1000*	0	0	0	0	0	0

*: pH-adjusted test concentration

Reference substances (if used):
48 h-LC50 of the positive control Chloroacetamide: about 24 mg/l (corresponds to normal sensitivity).

Behavior of the test item during the test:
No remarkable observations.

Observed symptoms (A: Apathy)

Nominal conc.(mg/l)	Symptoms after
	1 h	4 h	24 h	48 h	72 h	96 h
0
100
215				A	A	A
464		A
1000
1000*

*: pH-adjusted test concentration

pH values

Nominal conc.(mg/l)	pH values after
	1 h	24 h	48 h	72 h	96 h
0	8.2	8.0	8.0	8.0	8.0
100	9.8	8.8	8.1	8.2	8.2
215	10.1	9.4	8.8	8.3	8.1
464	10.4	9.9
1000	10.7
1000*	8.6	8.5	8.2	8.1	8.1

*: pH-adjusted test concentration

Oxygen content

Nominal conc.(mg/l)	Oxygen concentrations after
	1 h	24 h	48 h	72 h	96 h
0	8.9	8.3	8.0	8.5	8.7
100	8.2	8.5	8.4	8.6	8.8
215	8.4	8.5	8.0	7.8	7.9
464	8.5	8.5
1000	8.7
1000*	8.3	8.5	8.0	8.1	8.1

*: pH-adjusted test concentration

Description of key information

LC50 (96 h): 7.7 mg a.i./L (nominal, OECD 203).

Additional information

The acute toxicity of Alcohols, C12-14 (even numbered), ethoxylated (<=2.5 moles EO), sulfated, monoisopropanolamine salt to fish was tested according to OECD guideline 203 (GLP). Ten fish of the species Danio rerio were exposed to nominal test substance concentrations of 2.1, 3.5, 6.0, 10.0 and 17.0 mg/L in a flow-through system (flow rate: 10 L/h). The test concentrations were analytically verified using the MBAS assay (methylene blue active substances assay). The determined recovery rates were > 80%. The determined LC50 (96h) was 7.7 mg a.i./L (nominal).

Available data on short-term toxicity of monoisopropanolamine (MIPA) demonstrate no acute toxicity of the substance to fish. A study following German industrial standard test guideline DIN 38412 part 15 determined a LC50 (96 h) in the range of 215 - 464 mg/L (nominal). Neutralisation of the test concentrations resulted in a LC50 (96 h) > 1000 mg/L (nominal).