N,N-dimethylbutylamine

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:

6 October 1988 to 8 December 1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Version / remarks:

Cited as Directive 84/449/EEC, C.1 ("Acute toxicity for fish")

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

yes

Remarks:

test substance not measured

GLP compliance:

yes

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: the test substance was added to an aliquot of test water and dissolved using an ultra-turrax and ultrasonic bath. The stock solution was then dissolved in the test vessel. This resulted in pH-values in the range 9.8 to 10.6. The pH was adjusted with 0.64 to 2.6 mL of 1 n HCL, the exact volume depending on the respective dose level.
- Evidence of undissolved material: yes. Precipitate at 250 and 500 mg/L.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: zebra fish
- Strain: brachidanio rerio (Hamilton-Buchanan)
- Source: West Aquarium, Bad Lauterberg, Germany)
- Age at study initiation: approx. 15 weeks
- Length at study initiation (length definition, mean, range and SD): 2.8 cm (range 2.4 - 3.1 cm), SD 0.17 cm

ACCLIMATION
- Acclimation period: min 14 days
- Acclimation conditions: same as during testing. Temperature 22 ± 1 °C; light/dark 12/12 hours; oxygen saturation min 80 %
- Type and amount of food: Tetra Min, standard diet ad libitum
- Feeding frequency: twice daily

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Post exposure observation period:

n.a.

Hardness:

reconstituted water according to ISO/DIS 7346/1 was used

Test temperature:

22 ± 1 °C

pH:

7.5 to 8.1 (after neutralisation)

Dissolved oxygen:

7.1 to 9.0 mg/L

Nominal and measured concentrations:

0, 100, 125, 180, 250, and 500 mg/L

Details on test conditions:

TEST SYSTEM
- Type (open / closed): no data
- Material, size, headspace, fill volume: glass, fill volume 10 litres
- Aeration: static, no aeration during the test
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 4
- Biomass loading rate: 1 fish/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water according to ISO/DIS 7346/1
- Culture medium different from test medium: no
- Intervals of water quality measurement: at 0, 2-4, 24, 48, 72, and 96 hours after initiation.

OTHER TEST CONDITIONS
- Adjustment of pH: yes; the pH was adjusted with hydrochloric acid. The results refer therefore to the nominal concentrations of the neutralised test substance.
- Photoperiod: 12 hours/day
- Light intensity: 700 lux

EFFECT PARAMETERS MEASURED
- behavior and mortality was determined at 2-4, 24, 48, 72, and 96 hours after initiation.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.41

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

212 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

see below

Results with reference substance (positive control):

n. a.

Reported statistics and error estimates:

The LC50 was 212 mg/L (95 % CI: 189 - 239 mg/L).

Sublethal observations / clinical signs:

Mortality

Dose level (mg/L)	Number of dead animals
	48 h	96 h
0	0/40	0/40
100	0/10	0/10
125	0/10	0/10
180	0/10	1/10
250	5/10	9/10
500	10/10	10/10

 

The LC50 was 212 mg/L (95 % CI: 189 - 239 mg/L)

CLINICAL SYMPTOMS
No observation of high-dosed groups was possible due to rapid death of the animals.
The 125-mg/L group showed normal behaviour and appearance.
The animals of the 180- and 250-mg/L groups, but also at 100 mg/L, showed hypoactivity, increased respiration rate, extended gill covers, swimming near the surface, dark discolouration.

Validity criteria fulfilled:

yes

Conclusions:

The 96-hr LC50 was 212 mg/L in a GLP guideline study using zebra fish (neutralised test substance)

Executive summary:

The acute toxicity to fish was examined in a GLP and guideline-compliant study (OECD 203, EU C3) using Zebra fish (10/dose). The dose levels were 0, 100, 125, 180, 250, and 500 mg/L. Precipitation and high pH-values were observed after the addition of stock solutions to the vessels. Consequently, the pH was adjusted with hydrochloric acid, but no analytical monitoring of the test substance was performed. The results refer therefore to the nominal concentrations of the neutralised test substance.

Symptoms were seen at 100, 180 and 250 mg/L. 10 % mortality was seen at 180 mg/L, and 90 % at 250 mg/L, i.e. there was a steep dose-mortality curve. The LC50 was determined to be 212 mg/L (Markert and Jung, 1988).

 

The study is considered to be valid for the assessment of the neutralised test substance.

Description of key information

The LC50 was determined to be 212 mg/L.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

212 mg/L

Additional information

The acute toxicity to fish was examined in a GLP and guideline-compliant study (OECD 203, EU C3) using Zebra fish (10/dose). The dose levels were 0, 100, 125, 180, 250, and 500 mg/L. Precipitation and high pH-values were observed after the addition of stock solutions to the vessels. Consequently, the pH was adjusted with hydrochloric acid, but no analytical monitoring of the test substance was performed. The results refer therefore to the nominal concentrations of the neutralised test substance.

Symptoms were seen at 100, 180 and 250 mg/L. 10 % mortality was seen at 180 mg/L, and 90 % at 250 mg/L, i.e. there was a steep dose-mortality curve. The LC50 was determined to be 212 mg/L (Markert and Jung, 1988).

 

The study is considered to be valid for the assessment of the neutralised test substance.