2-ethoxy-5-(4-methyl-1-piperazinylsulfonyl)benzoic acid

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Between 3 and 7 February 1997.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: done under GLP and OECD method

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: Method C1, Directive 92/69/EEC

Test guideline 2

Qualifier:

according to guideline

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:

yes

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Remarks:

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:

yes

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

Vehicle:

no

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.
Acclimatisation

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:

static

Water media type:

freshwater

Limit test:

yes

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

pH:

Between 7.78 and 7.94

Dissolved oxygen:

9.80mgO/I

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):

yes

Remarks:

potassium dichromate

Results and discussion

Effect concentrations

Duration:

96 h

Dose descriptor:

EC50

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:

yes

Conclusions:

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.