Butyl(ethyl)amine

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1998-01-28 - 1998-02-06

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Version / remarks:

Cited as Directive 92/69/EEC, C.1

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Butyl(ethyl)amine

EC Number:

236-415-0

EC Name:

Butyl(ethyl)amine

Cas Number:

13360-63-9

Molecular formula:

C6H15N

IUPAC Name:

butyl(ethyl)amine

Details on test material:

- Name of test material (as cited in study report): N-Ethylbutylamin
- Physical state: liquid
- Analytical purity: 99.76%
- Expiration date of the lot/batch: December 1998
- Storage condition of test material: darkness at 20°C

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 0, 220, 500, and 1000 mg/L
- Sample volume: 20 mL
- Sampling method: no data
- Sample storage conditions before analysis: no data

Test solutions

Vehicle:

no

Test organisms

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebra fish
- Source: Hoechst Marion Roussel, Germany
- Age at study initiation: 3 months
- Body length: mean 3.0 +/- 0.19 cm
- Feeding during test: no

ACCLIMATION
- Acclimation period: 14 days
- Acclimation conditions: same as test
- Type and amount of food: ad libitum
- Feeding frequency: twice daily ad libitum
- Food type: Tetra Min

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Test conditions

Test temperature:

21.2 - 21.7 °C

pH:

7.7 - 8.2 (adjusted)

Dissolved oxygen:

6.4-10.1 mg/L

Nominal and measured concentrations:

Nominal: 100, 220, 500, 1000 mg/L
Analytical: nd., 225, 496, 996 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: glass
- - Material, size, headspace, fill volume: glass, 4 L
- Aeration: no
- Renewal rate of test solution (frequency/flow rate):no, static
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water, composition according to ISO/DIS 7346/1

OTHER TEST CONDITIONS
- Adjustment of pH: yes
- Photoperiod: 12 hr light /dark
- Light intensity: 700 Lx

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Observation for changes and mortality at 3, 6, 24, 48, 72, and 96 hours

Reference substance (positive control):

not required

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

220 mg/L

Remarks on result:

other: IUCLID4 note: "m" (measured/nominal)

Effect concentrations 2

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

332 mg/L

Remarks on result:

other: IUCLID4 note: "m" (measured/nominal)

Effect concentrations 3

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

500 mg/L

Remarks on result:

other: IUCLID4 note: "m" (measured/nominal)

Any other information on results incl. tables

Sublethal observations / clinical signs:

Mortality:      

48 h        96 h
==========================================
 Control:        0/7          0/7     died
 100 mg/l:       0/7          0/7     died
 220 mg/l:       0/7          0/7     died
 500 mg/l:       6/7          7/7     died
1000  mg/l:      7/7         7/7     died  

============================================  

The mean LC50(96 h) was calculated to be 332 mg/l based on the geometric  mean of the LC0 of 220 and LC100 of 500 mg/l.  


Signs of discomfort and intoxication:
At 1000 mg/l, no observation was possible due to rapid death.
At 220 and 500 mg/l, in all animals, at 100 mg/l, in solitary cases,  changes in appearance, behaviour, swimming behaviour and 

respiration rate  were observed throughout the whole test period.

Dead fish showed dark-coloured or metallic sheen integument and lock-jaw. 

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The LC50(96 hr) was 332 mg/L,

Executive summary:

The acute toxicity of the test substance to fish (zebra fish) was examined in an OECD TG 203 study (static) under GLP conditions. The nominal concentrations were 0, 100, 220, 500, and 1000 mg/L. The analytical concentration of the three top concentrations was within +/- 10% of the nominal concentration. All fish died at the top concentration. The calculated LC_{50(96 hr)}was 332 mg/L, based on the results of groups at 100, 220, and 500 mg/L in this study (Hoechst Marion Roussel, 1998).

The study is considered to be valid and suitable for assessment.