1H,5H-Pyrazolo(1,2-a)pyrazol-1-one, 2,3-diamino-6,7-dihydro-, dimethanesulfonate

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:

From 04 December 2006 to 29 June 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: compliant to GLP and testing guideline; adequate coherence between data, comments and conclusions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

GLP compliance:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of test material (as cited in study report): R0054002C, synonym IMEXINE OBH
- Physical state: beige to yellow powder
- Purity: 99.7%
- Impurities (identity and concentrations): not indicated
- Purity test date: 20 July 2006
- Lot/batch No.: R0054002C 013 L 001, synonym 0604070001
- Expiration date of the lot/batch: 01 August 2007
- Stability under test conditions: not indicated
- Storage condition of test material: at room temperature and under nitrogen gas

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

Samples were taken from the limit test solution (1000 mg/L) at the beginning of the test, before and after each solution change and at the end of the test.

Test solutions

Vehicle:

no

Test organisms

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

zebra fish (Danio rerio) a species commonly used in Europe for aquatic toxicity testing and recommended in OECD and EEC guidelines.
Origin: HB Développement, Saint Forgeux, France

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test conditions

Hardness:

147 and 149 mg/L as CaCO3

Test temperature:

Between 21.4°C and 22.2°C

pH:

pH: 6.17 to 8.46

Dissolved oxygen:

8.1 to 9.2 mg/L (≥ 60% of the air saturation value)

Salinity:

Not measured

Nominal and measured concentrations:

limit test: 1000 mg/L nominal corresponding to 659 mg/L expressed as geometric mean of measured concentrations
range finding test: 100 and 316 mg/L nominal (no measurement)

Details on test conditions:

Test solutions were changed every 24 over the 96-hour test period.

Test water: filtered and dechlorinated potable water which is then softened by a Permo® water softening system. Half of the water passes directly into a holding tank attached to the flow-through system while the remaining half passes through a deionizer producing ultra-pure water which is then fed into the holding tank. This results in a 1:1 dilution of potable dechlorinated:deionized water giving a supply of the desirable hardness. The pH of this medium is between 6.0 and 8.5 (generally in the range 7.5 - 8.0) and the total hardness is between 10 and 250 mg/L as CaCO3 (generally in the range 130 - 170 mg/L as CaCO3).

Temperature: between 21°C and 25°C and not ranging by more than ± 1°C throughout the test.

Light/dark cycle: 16/8 hours.

Duration of test: 96 hours.

Loading: fish mean weight was 2.32 g for the test, based on a sample of ten animals removed at random from the acclimation tank just before the test.This corresponded to a loading of 0.81 g/L during the study.

Length: the animals ranged from 25 to 30 mm long (based on a measurement of a sample of 31 fishes used in the test).

pH in test item solutions: between 6 ± 0.2 and 9 ± 0.2 after pH adjustment when relevant (i.e. < 5.8 or >9.2).

Forced aeration: continuously used during the test in all solutions. Dilution water was aerated prior to addition of the test item.

Oxygen concentrations: ≥ 60% of the air saturation value at that temperature.

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 659 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

dissolved

Basis for effect:

mortality (fish)

Effect concentrations 2

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

>= 659 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

dissolved

Basis for effect:

other: mortalilty and sub-lethal effects

Details on results:

Neither mortality nor sub-lethal effects were noted at any of the concentrations tested (100, 316 and 1000 mg/L nominal).

Results with reference substance (positive control):

LC50 24 h (potassium dichromate) = 233 mg/L

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

In a 96-hour semi-static acute toxicity test with Danio rerio, the LC50 of IMEXINE OBH was > 659 mg/L (geometric mean of measured concentrations).
The No Observed Effect Concentration (NOEC) was ≥ 659 mg/L (geometric mean of measured concentrations).