Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: 1d: Reliable with restriction; guideline study but no analyses were performed to confirm the nominal test concentrations according to guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Qualifier:
according to
Guideline:
other: Guideline 84/449/EWG
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Trade name material: Genamin CS 301
- Purity: not stated
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
not relevant

Sampling and analysis

Analytical monitoring:
not specified
Details on sampling:
no data

Test solutions

Vehicle:
yes
Details on test solutions:
Since the test substance is insoluble in water and since no better distribution was achieved using solvents and emulators, the test substance mixed with dilution water was homogenized using the Ultra-Turrax and ultrasonic bath. This solution was added to the test vessel while being stirred with at glass stirring rod. Finally, the contents of the test vessels were stirred for 2 hours with a KPG-stirrer and a glass stir rod.
At 2.2 and 10 mg/l, test substance deposits were observed.

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
- Common name: Zebrafish
- Source: Hamilton-Buchanan/West Aquarium, Bad Lauterberg
- The fish were held in dilution water for at least 14 days before the beginning of the study.
- Mean body length of 10 fish = 3.0 cm

Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h

Test conditions

Hardness:
no data
Test temperature:
22 ± 1°C
pH:
between 8.0 and 8.3
Dissolved oxygen:
> 80% oxygen saturation
Salinity:
no data
Nominal and measured concentrations:
Nominal concentrations: 2.2, 5, 10 and 50 mg/L
Measured concentrations: not stated
Details on test conditions:
TEST SYSTEM
- Test vessel: 10-liter glass aquariums (30 x 22 x 24 cm)
- Aeration: no
- Feeding during test: no
- No. of organisms per vessel and control: 10

TEST MEDIUM / WATER PARAMETERS
- Dilution water was reconstituted water mixed to provide a composition following ISP/DIS 7346/l.

OTHER TEST CONDITIONS
- Photoperiod: 12-hour day/night cycles
- Light intensity: approximately 700 lux
- Feeding: twice daily
Reference substance (positive control):
not required

Results and discussion

Effect concentrations
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
6.15 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 95% CL = 4.5 to 8.3 mg/L
Details on results:
- Statistical methods: Probit analysis (Linder and Weber, confidence interval Fieller)
- After 2, 4, 24, 48, 72 and 96 hours, mortality and visible changes in appearance and behavior were noted. Dead fish were removed from the vessels. Fish were counted as dead when breathing was no longer seen and the fish no longer responded to a light mechanical stimulation.
- In all the test substance groups, impaired swimming, breathing as well as changed appearance and behavior were observed. Fish that died were pale or darkly colored and showed red gills and lockjaw.
- At the concentration 5 mg/L, 3 fish died after 96h. At the concentration 10 mg/L, 3 fish died after 48h and 9 died after 96h. All fish died after 48h at the concentration of 50mg/L.
- Additional endpoints included:
- 48-hour LC0 = 5 mg/l
- 96-hour LC0 = 2.2 mg/l
- 48-hour LC50 = > 10 mg/l and < 50 mg/l
- 48-hour LC100 = 50 mg/l
- 96-hour LC100 = 50 mg/l
Results with reference substance (positive control):
not relevant

Applicant's summary and conclusion

Validity criteria fulfilled:
not specified
Executive summary:

Acute toxicity of dicocomethylamine to Brachydanio rerio has been examinated through OECD Guideline 203, EU Method C.1 and GLP requirements.

Brachydanio rerio were exposed for 96 hours to dicocomethylamine

at nominal concentrations of 2.2, 5, 10 and 50 mg/L.

LC 50 - 96h was determined to be of 6.15 mg/L.