Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well performed OECD study with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzamide, 3-amino-N-[4-(aminocarbonyl)phenyl]-4-methoxy-, hydrochloride
EC Number:
618-990-3
Cas Number:
939961-06-5
Molecular formula:
C15H15N3O3xClH
IUPAC Name:
Benzamide, 3-amino-N-[4-(aminocarbonyl)phenyl]-4-methoxy-, hydrochloride

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
Substance was not completed dissloved. Therefore, for the analytics samples of the suspension were taken and the total content was determined.
Samples were taken at 0 hours as well after 48 and 96 hours.

Test solutions

Vehicle:
no
Details on test solutions:
Homogenization with ultrasonic and utra-turrax,
not completely dissolved

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebrabärbling
- Strain: Hamilton-Buchanan
- Source: West Aquarium, 3422 Bad Lauterberg
- Length at study initiation: 2.6 - 3.4 cm:
- Feeding during test: no

ACCLIMATION
- Acclimation period: at least 14 days
- Acclimation conditions: same as test
- Type and amount of food: Tetra Min, Tetra Werke, Melle; twice a day, ad libitum

Study design

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

Test conditions

Test temperature:
test groups: 21.3 - 21.8 °C
controls: 21.0 - 22.0 °C
pH:
test groups: 6.8 - 7.7
controls: 7.9 - 8.3
Dissolved oxygen:
test groups: 7.1 - 9.1 mg/L
controls: 7.6 - 9.7 mg/L
Nominal and measured concentrations:
nominal measured
(mg/L) (mg/L)
220 251.7
500 505
Details on test conditions:
TEST SYSTEM
- Test vessel: open glass vessel, 30 cm x 22 cm x 24 cm, calibrated for 10 liters
- Aeration: during test : no
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 2

TEST MEDIUM / WATER PARAMETERS
- Preparation of dilution water: according to ISO/DIS 7346/1

OTHER TEST CONDITIONS
- Photoperiod: 12 hours dark / 12 hours light
- Light intensity: 700 Lux

Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
LC10
Effect conc.:
500 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
220 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 500 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
Observations:
projecting opercula, panting, lateral and supine position, swim posture tail-heavy,

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The substance has not to be classified for toxicity to fish since the LC50 is greater than 500 mg/L.
Executive summary:

The substance was tested for acute toxicity to the fish Brahydanio rerio for 96 hours according to OECD guideline 203. The test was performed in two groups with 0 mg/L (control) and 220 mg/L and with 0 mg/L and 500 mg/L. After 24 hours 10% lethality occurred in the 500 mg/L group. For each test 10 fish were used. Observations during the study were projecting opercula, panting, lateral and supine position, tail heavy swim posture.

Based on the results the LC50 can be determined as greater than 500 mg/L