Registration Dossier

Ecotoxicological information

Short-term toxicity to fish

Currently viewing:

Administrative data

short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Between 3 and 7 February 1997.
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: done under GLP and OECD method

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guidelineopen allclose all
according to guideline
other: Method C1, Directive 92/69/EEC
according to guideline
OECD Guideline 203 (Fish, Acute Toxicity Test)
Principles of method if other than guideline:
The study was conducted in accordance with EEC Methods for Determination of Ecotoxicity Annex to Directive 92/69/EEC (O.J. No. L383A, 29.12.92) Part C, Method 1 "Acute toxicity for Fish" and the OECD Guideline for Testing of Chemicals No. 203 "Fish, Acute Toxicity Test".

GLP compliance:

Test material

Constituent 1
Chemical structure
Reference substance name:
2-ethoxy-5-(4-methyl-1-piperazinylsulfonyl)benzoic acid
EC Number:
EC Name:
2-ethoxy-5-(4-methyl-1-piperazinylsulfonyl)benzoic acid
Cas Number:
Molecular formula:
C14 H20 N2 O5 S
2-ethoxy-5-[(4-methylpiperazin-1-yl)sulfonyl]benzoic acid
Test material form:
solid: particulate/powder
migrated information: powder
Details on test material:
Identity: UK-143,108

Chemical name: 2-Ethoxy-5-( 4-methyl-1-piperazinesulphonyl) benzoic acid

Intended use: Pharmaceutical intermediate

Appearance: White to off-white powder

Storage conditions: Room temperature in the dark

Sample reference: CPI/96 070

Expiry date: Not supplied

Purity: 101.3%

Date received: 2 October 1996

Sampling and analysis

Analytical monitoring:
Details on sampling:
At the beginning and then at 96hrs for the 22, 48 and 100 % concentrations. Also ran a stability sample concurrent to look for maintenace of test solution concentration.

Test solutions

Details on test solutions:
Identity and concentration of auxiliary solvent for dispersal: No auxiliary solvents were required. Neat

Test organisms

Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
Rainbow trout
Source: Westacre Trout Farm, Norfolk, UK.

The stock of fish was obtained from the supplier on 20 September 1996 and acclimatised to test conditions from 26 December 1996. Temperature remained at I 5°C and dissolved oxygen within the range 9.0 to 9.7 mg02/l in the 14-day period immediately prior to the study. The fish were fed daily to repletion with commercial fry pellet but food was not given during the 24 hour period immediately prior to exposure or during the exposure period itself. No medication was given during the acclimatisation period and no mortalities were recorded in the 7 days prior to the test.

Control fish were measured at the end of the exposure period. The mean standard length was 5.97 cm (SD = 0.407) and the mean weight was 3.06 g (SD = 0.581).

Study design

Test type:
Water media type:
Limit test:
Total exposure duration:
96 h
Post exposure observation period:
Observations were made on the numbers of dead fish and the incidence of sub-lethal effects after 3, 6, 24, 48, 72 and 96 hours exposure

Test conditions

Test temperature:
Treatment and control groups were maintained at 13 ± 1°C throughout the exposure period
Between 7.78 and 7.94
Dissolved oxygen:
Nominal and measured concentrations:
Nominal concentrations:4.6, 10, 22, 46 and 100 mg/I
Mean measured concentrations: 4.77, 10.2, 22.5, 47.1, and 101 mg/I
Details on test conditions:
Following preliminary range finding between 0.1 and 100 mg/I, 5 test concentrations were chosen plus one untreated control. Seven fish were added to each vessel.

Fish were placed at random in glass aquaria containing prepared test medium or diluent water. Each vessel contained 40 litres of medium to a depth of 27 cm (approximate dimensions of vessel: 32 x 53 x 38 cm). This provided a loading of 0.536 g bodyweight/litre.
Reference substance (positive control):
potassium dichromate

Results and discussion

Effect concentrations
96 h
Dose descriptor:
Effect conc.:
> 100 mg/L
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
A single dead fish was observed in the 46 mg/I test concentration after 48 hours of this study. This level of mortality, along with the absence of sublethal effects, is not considered to be biologically significant and therefore the no observed effect concentration (NOEC) is 100 mg/I.

Applicant's summary and conclusion

Validity criteria fulfilled:
The 96 h LC50 value for UK-143,108 with rainbow trout was >100 mg/I.

The 'no-observed effect concentration' for UK-143,108 with rainbow trout is considered to be 100 mg/I, the highest concentration tested.