2-isopropyl-N-hydroxyethyl 1,3-oxazolidine;methyl carbonato-N-ethyl-2-isopropyl-1,3-oxazolidine;reaction mass of: carbonato-bis-N-ethyl-2-isopropyl-1,3-oxazolidine

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:

from 1998-10-02 to 199-01-20

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

The study is regarded as reliable without restrictions because it was conducted in compliance with GLP regulation and guideline.

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Version / remarks:

citred as: Directive 92/69/EEC (July 1992)

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

adopted: 17 Jul 1992

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 100, 50, 25, 12.5 and 6.3 mg/L.
- Sampling method:
Analytical samples were taken from each test medium to determine the concentration of the major breakdown product of Incozol LV. Analytical samples were taken at the start and end of the first and fourth exposure periods. Measured concentrations of the major breakdown product of Incozol LV were determined. The toxicity of Incozol LV to O. mykiss was based on the nominal Incozol LV concentrations.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method:
The dilution water used was mains dechlorinated water. The test media were prepared by direct addition of Incozol LV to the test vessels, the test vessels were then fully filled, sealed and stirred using a magnetic stirrer for approximately 2 h. A control treatment was prepared containing dilution water only. An identical procedure was used after 24, 48 and 72 h to prepare fresh test media. The concentration range used in the definitive study was based on the results of a range-finding test and used the following nominal Incozol LV concentrations: 100, 50, 25, 12.5 and 6.3 mg/L.

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: Rainbow trout
- Source: Brow Well Fisheries Ltd. (Low Mill, Grassington, Skipton, North Yorkshire, UK)
- Length at study initiation: mean fork length of 4.4 cm (range 4.0 to 5.0 cm)
- Weight at study initiation: mean wet weight of 0.7851 g (range 0.6079 to 1.1234 g)
- Feeding during test: They were not fed during the test.

ACCLIMATION
- Acclimation period: 12 days before use
- Acclimation conditions: same as test conditions
- Type and amount of food: The fish were fed a proprietary food (Trouw 00) Food was supplied to the fish in quantities dependent on the size of the fish. The food was not considered to contain contaminants likely to affect the outcome of the study.
- Feeding frequency: daily
- Health during acclimation: Fish mortalities were recorded daily. No mortalities were observed.

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

52.0 to 52.5 CaCO3 (mg(L)

Test temperature:

12.9 to 13.8 °C

pH:

7.1 to 7.5

Dissolved oxygen:

97 (% air saturation value)

Salinity:

Alkalinity Total 16.1 mg/L HC03
Colour True 3.1 Hazen
Conductivity 20 °C 154 µS/cm
Turbidity 0.36 FTU
Nitrate 6.45 mg/L N03
Nitrite <0.010 mg/L N02
Nitrogen Ammoniacal <0.04 mg/LNR,
Chloride 14.5 mg/L CI
Phosphorous 1020 Hg/LP
Sulphate 31.4 mg/L SO4
Aluminium 30 µg/LAl
Calcium 15.2 mg/L Ca
Copper 30 µg/L Cu
Iron 47 mg/L Fe
Lead 5.25 µg/L Pb
Magnesium 2.82 mg/L Mg
Manganese 16 mg/L Mn
Potassium 1.28 mg/LK
Sodium 10.4 mg/L Na
Zinc 554 mg/LZn
Aldrin <0.005 µg/L
DDT (pp) <0.01 mg/L
Dieldrin 0.003 µg/L
Endrin <0.02
HCH gamma <0.005 µg/L
Colonies 1 Day 37°C 0 No/mL
Colonies 3 Day 22°C 22 No/mL
Faecal Coli forms 0 No/100 mL
Free Chlorine <0.05 mg/L CI
Total Chlorine <0.05 mg/L CI
Total Coliforms 0 No/100 mL

Conductivity:

at 20 °C - 154 µS/cm

Nominal and measured concentrations:

nominal : 100, 50, 25, 12.5 and 6.3 mg/L.
measured: 130, 56, 41, 23, 14 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 10 L glass vessels
- Type : closed
- Material, size, headspace, fill volume: The test vessels were 10 L (nominal volume) glass vessels containing 11.3 L of test medium when fully filled, test vessels were sealed with glass plates.
- Aeration: The test vessels were not aerated during the test.
- Renewal rate of test solution: ever 24 h
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 7
- No. of vessels per control (replicates): 7

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: The water used for the holding of stocks and for the toxicity test with O. mykiss was the laboratory mains supply. The water is pumped to the laboratory via a Purite AC9 activated carbon filter and a Purite ROPF 20 particulate filter, and then heated to approximately 14 °C.
- Chlorine: free chlorine <0.05 mg/L Cl
- Conductivity: 154 µS/cm
- Culture medium different from test medium: no

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Light intensity: artificial light, with a 16 h light cycle

TEST CONCENTRATIONS
Nominal
concentration Measured concentration of major Incozol LV breakdown product (mg/L)
(mg/L) 0 h (new) 24 h (old) 72 h (new) 96 h (old)
Control nd, nd nd, nd nd, nd nd, nd
6.3 14* 11* nd, nd 23* 21* nd, 5*
12.5 23* 21* nd, 32* 27*,26* 3*, 14*
25 41*, 37* 32*, 36* 37*, 33* 28*,30*
50 56, 50 53,57 60,64 60, 53
100 130, 102 105, 94 104, 109 113,113
nd - not detected
* - below the lowest calibration point, 50 mg/L

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

85.7 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

50 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Sublethal observations / clinical signs:

Nominal Concentration (mg(L)	No. of fish	Observation time and symptom classification *
		1h				24 h				48 h				72h				96 h
		a	b	c	d	a	b	c	d	a	b	c	d	a	b	c	d	a	b	c	d
Control	7	7	0	0	0	7	0	0	0	7	0	0	0	7	0	0	0	7	0	0	0
6.3	7	7	0	0	0	7	0	0	0	7	0	0	0	7	0	0	0	7	0	0	0
12.5	7	7	0	0	0	7	0	0	0	7	0	0	0	7	0	0	0	7	0	0	0
25	7	7	0	0	0	7	0	0	0	7	0	0	0	7	0	0	0	7	0	0	0
50	7	7	0	0	0	7	0	0	0	7	0	0	0	6	1	0	0	6	1	0	0
100	7	7	0	0	0	0	7	0	0	1	6	0	0	0	2	0	5	0	1	0	6

 

* symptom classification

(a) No toxic effects

(b) Mild toxic effects: swimming normally but exhibiting mild effects, e.g. increased cough frequency, swimming position in test vessel different to the controls

(c) Severe toxic effects: e.g. swimming abnormally or lying on the bottom of tank.

(d) Fish dead

Validity criteria fulfilled:

yes

Conclusions:

The 96-h LC50 of Incozol LV based on nominal exposure concentrations was calculated to be 85.7 mg/L, and the 96-h NOEC was determined to be 50 mg/L.

Executive summary:

A 96-hour semi-static study was conducted according to OECD TG 203 and Directive 92/69/EEC method C.4 to determine the acute toxicity of Incozol LV to Oncorhynchus mykiss. The concentration range included the following nominal Incozol LV concentrations: 100, 50, 25, 12.5 and 6.3 mg/L. The test media were prepared by direct addition of Incozol LV to the test vessels, the test vessels were then fully filled, sealed and stirred for approximately 2 h. A control treatment was prepared containing dilution water only. Analytical samples were taken from each test medium to determine the concentration of the major breakdown product of Incozol LV. Analytical samples were taken at the start and end of the first and fourth exposure periods. The 96-h LC50 of Incozol LV to O. mykiss based on nominal exposure concentrations was calculated to be 85.7 mg/L. The 96-h NOEC was determined to be 50 mg/L.

Description of key information

The 96-h LC50 of Incozol LV based on nominal exposure concentrations was calculated to be 85.7 mg/L, and the 96-h NOEC was determined to be 50 mg/L.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

85.7 mg/L

Additional information

A 96-hour semi-static study was conducted according to OECD TG 203 and Directive 92/69/EEC method C.4 to determine the acute toxicity of Incozol LV to Oncorhynchus mykiss. The concentration range included the following nominal Incozol LV concentrations: 100, 50, 25, 12.5 and 6.3 mg/L. The test media were prepared by direct addition of Incozol LV to the test vessels, the test vessels were then fully filled, sealed and stirred for approximately 2 h. A control treatment was prepared containing dilution water only. Analytical samples were taken from each test medium to determine the concentration of the major breakdown product of Incozol LV. Analytical samples were taken at the start and end of the first and fourth exposure periods. The 96-h LC50 of Incozol LV to O. mykiss based on nominal exposure concentrations was calculated to be 85.7 mg/L. The 96-h NOEC was determined to be 50 mg/L.