Hyoscine

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:

1995-03-10 to 1995-03-22

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Justification for type of information:

The read-across justification is included as an attachment to Iuclid section 13.

Qualifier:

according to guideline

Guideline:

other: DIN 38412 L31

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

GLP compliance:

not specified

Analytical monitoring:

no

Vehicle:

no

Test organisms (species):

Leuciscus idus

Details on test organisms:

TEST ORGANISM
- Common name: Gold orfe (Leuciscus idus)
- Source: Fischzucht Eggers, Postfach 12, 24594 Hohenstedt, Germany
- Length at study initiation (length definition, mean, range and SD): 5-8 cm
- Feeding during test: no
ACCLIMATION
- Acclimation period: one week quaratine
- Acclimation conditions (same as test or not): not
- Feeding frequency: daily

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

Sum of Ca and Mg ions: 2.5 mmol/L

Test temperature:

20+-1°C

pH:

6.8 to 7.2

Dissolved oxygen:

8.3 to 8.6 mg O2/L

Salinity:

not applicable

Nominal and measured concentrations:

0, 2, 3, 4, 5, 6 g/L

Details on test conditions:

TEST SYSTEM
- Test vessel: all glass aquarium (30 L)
- Water volume per vessel: 10 L
- Aeration: min. 80% from saturation value
- No. of organisms per vessel: 3 fish per concentration
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Day-Light-Cyclus: 16 h:8 h
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: test medium was prepared from reagent grade salts (Ca, Mg, Na, K) and demineralized water- Ca/Mg ratio: 4:1- Conductivity: 0.5 µS/cm

Reference substance (positive control):

no

Key result

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

2 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: no- Observations on body length and weight: 6.5 to 7.3 cm; 2.2 to 3.1 g- Mortality of control: no

Sublethal observations / clinical signs:

Cumulative mortality

Nominal concentration (g/L)	24 h	48 h
control	0	0
2	0	0
3	2	2
4	0	1
5	2	2
6	2	2

Validity criteria fulfilled:

yes

Conclusions:

The toxicological concentration limit for buscopan is 2 g/L at 20°C under the conditions of the test. In consequence, the NOEC is 2 g/L.

Description of key information

A 48-hour NOEC of 2 g/L was determined for the effects of the read-across substance Hyoscine butylbromide on mortality for fish according to an reliable study. No LC50 was determined in this study, the LC50 will be defined to be >2 g/L.