Registration Dossier

Ecotoxicological information

Short-term toxicity to fish

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
other information
Study period:
November 17 to november 28, 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD, GLP study
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
Principles of Good Laboratory Practice, annex of paragraph 19a, section 1 of the chemical law.
Principles of method if other than guideline:
Principles of Good Laboratory Practice, annex of paragraph 19a, section 1 of the chemical law.
GLP compliance:
yes
Test material information:
Composition 1
Specific details on test material used for the study:
Test material form: solid - liquid: suspension

- Name of test material (as cited in study report): Azacyclonol-Base
- Physical state: white powder
- Purity: 98.3 % (w/w)
- Batch No.: 86000298
- Storage conditions: darkness at approximately 5 °C in a refrigerator
- Date of expiry: September 10, 1998
- Solubility in water: not soluble
Analytical monitoring:
yes
Details on sampling:
Aqueous solutions of 20 ml diluted in methanol.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebra fish
- Strain: Danio rerio
- Origin: Hoechst Marion Roussel Deutschland GmbH Global Preclinical Development - Drug Safety
- Length at study initiation: 2.6 cm ± 0.08 (variation range: 2.5-2.7)
- Food type: Tetra Min, Tetra Werke, Melle (Germany)

ACCLIMATION
- Acclimation period: 14 days in water for dilution
- Acclimation conditions: light period: 12 hours daily
- Population density: <= 1 g fish/L water
- Food type:Tetra Min, Tetra Werke, Melle (Germany)
- Feeding frequency: twice daily ad libitum
Test type:
static
Water media type:
not specified
Total exposure duration:
96 h
Hardness:
In a range of 2.3 - 2.5 mmol Ca2+ + Mg2+/ L during the study.
Test temperature:
22 .± 1 °C
pH:
Initial pH in study batch: in the range of 8.3-8.5
pH after adding the substance in the 500 mg/L group: 9.6. The pH was adusted with concentrated HCI.
pH after substance addition in the 100 and 220 mg/L groups was below the maximum tolerable value of 9.
Dissolved oxygen:
>= 80% of the saturation value
Oxygen content in concentration groups: 7.0 - 8.8 mg/L
Nominal and measured concentrations:
Test concentrations: 0, 100, 220 and 500 mg/L
Nominal concentrations: 0, 100 and 220 mg/L
Measured concentrations: 111 and 243 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: test chambers, which were calibrated to 4 liters
- Aeration: test chambers were not aerated during the course of the study.
- No. of organisms per vessel: 7 fishes
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 1

OTHER TEST CONDITIONS
- Adjustment of pH: with HCl
- Photoperiod: from above from 06.00 a.m to 06.00 p.m
- Light intensity: 700 lux

TEST CONCENTRATIONS
Experimental part 1: 7 fish allocated in 2 chambers received 0 and 500 mg/L.
Experimental part 1: 7 fish allocated in 3 chambers received 0, 100 and 220 mg/L.
Key result
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
ca. 100 mg/L
Nominal / measured:
meas. (not specified)
Basis for effect:
mortality
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
ca. 148 mg/L
Nominal / measured:
meas. (not specified)
Basis for effect:
mortality
Key result
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
ca. 220 mg/L
Nominal / measured:
nominal
Basis for effect:
mortality
Remarks on result:
other: All values determined were in a range of ± 20 % of the theoretical value.
Details on results:

In all tested concentration groups: changes in appearance, behavior, swimming behavior and respiration rate during the entire exposure time.
ln the 500 mg/L groups: recording of symptoms was not possible because of 100 % lethality at the first inspection date.
ln the 2200 mg/L group: symptoms and lethality were observed.
ln the 100 mg/L group: symptoms but no lethality.
Dead fish showed substance deposits on integument, metallic sheen or dark coloured integument.
Results with reference substance (positive control):
Probit analysis could not be carried out because of the lethality rate. As the factor for the concentration steps was 2.2 (third root of 10), no further concentrations were tested.The geometrie mean of the LC0 and LC100 is given.
Validity criteria fulfilled:
yes
Conclusions:
The LC50 of Azacyclonol-Base after 96 hours was 148 mg/L.
Executive summary:

The LC50 of Azacyclonol-Base after 96 hours was 148 mg/L.

Description of key information

Hazardous to the aquatic environment - acute

Available acute toxicity values on fish for the Azacyclonol are:

 - LC5096h: 148 mg/L

Details on results:

 -in all tested concentration groups (100 mg/L to 500 mg/L): changes in appearance, behavior, swimming behavior and respiration rate during the entire exposure time.

 -in the 500 mg/L groups: recording of symptoms was not possible because of 100 % lethality at the first inspection date.

 -in the 2200 mg/L group: symptoms and lethality were observed.

 -in the 100 mg/L group: symptoms but no lethality.

Dead fish showed substance deposits on integument, metallic sheen or dark coloured integument.

Overall, this data are judged conclusive but not sufficient for classification.

Key value for chemical safety assessment

LC50 for freshwater fish:
148 mg/L

Additional information

Overall, this data are judged conclusive but not sufficient for classification.