Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1994-1995
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:
1995
Report date:
1995

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:
Sodium p-(3-amino-4-methylbenzamido)benzenesulphonate
EC Number:
275-177-2
EC Name:
Sodium p-(3-amino-4-methylbenzamido)benzenesulphonate
Cas Number:
71077-34-4
Molecular formula:
C14H14N2O4S.Na
IUPAC Name:
sodium 4-[(3-amino-4-methylbenzoyl)amino]benzenesulfonate

Test solutions

Vehicle:
no
Details on test solutions:
The test substance was weighed into a beaker. Water for dilution was added, the mixture was homogenized using an Ultra-Turrax and it was then poured into the chamber under stirring with a glass rod.
All tested concentrations were present as clear solutions. All test batches were homogeneous. No particulate matter was observed.

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: zebra fish
- Strain: HAMILTON-BUCHANAN
- Source: Corporate Toxicology (Hoechst AG)
- Date of hatching: 07/02/94; 08/18/94
- Delivery date: 09/13/94; 10/06/94
- Feeding during test: twice daily ad libitum
- Food type: Tetra Min, Tetra Werke, Melle (FRG)
- Length: 3.0 +-0.15cm;

ACCLIMATION
- Acclimation period: 14 days
- Acclimation conditions: same as test
- Type and amount of food: Tetra Min, Tetra Werke, Melle (FRG)
- Feeding frequency: twice daily ad libitum

Study design

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

Test conditions

Hardness:
2.5 mmol Ca2+/Mg2+ / L
Test temperature:
22+-1 °C
pH:
8.1 - 8.3
Dissolved oxygen:
7.3 - 9.5 mg/L
Nominal and measured concentrations:
nominal: 100 mg/L measured: 101 mg/L
Details on test conditions:
The study consisted of 2 parts. There were 7 fish in each group. The test concentrations, which were selected on the basis of range-finding tests, were as follows:
Part of study Start Test chamber No. Concentration (mg/L)
1 12/19/1994 1 /3 0/50
2 12/27/1994 10/5 0/ 100

The study was conducted in a static system. The test chambers, which were calibrated to 10 liters, were made of glass (length 30 cm, width 22 cm, height 24
cm) and stood in a water bath made of Hostalit Z® with a Plexiglas viewing panel. The temperature of the water bath was regulated by a thermostat to 22 :!:. 1 °C. The chambers were illuminated from above from 06.00 a.m to 06.00 p.m. The light intensity directly over the chambers was approximately 700 lux.
The test chambers were not aerated during the course of the study.
Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
50 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The LC50 is greater than 100 mg/L
Executive summary:

When testing the lethal effect of the substance in zebra fish (Brachydanio rerio) over a total of 96 hours according to OECD 203, no lethality occurred at 50 and 100 mg/L. The LC50 after 96 hours therefore exceeds 100 mg/L. The fish showed only slight symptoms which were reversible within 24 hours after study start. The concentrations tested were 50 and 100 mg/L and a negative control (0 mg/L).