Fenspiride

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18 to 20 august 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

The objective of the study is to assess the acute toxicity of 428 base brute, on Daphnia magna STRAUS - clone 5, in a 48 hour static test .
Due to the small size of the animal, mortality is difficult to determine and therefore the test criterion of acute toxicity used is immobilization, expressed as EC50 (Median Effective Concentration,a statistically derived concentration of the test item in water at which 50% of animals are immobilized). An animal is defined as immobile when it is incapable of swimming within 15 seconds after gentle agitation of the rest container.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Fenspiride

EC Number:

225-751-3

EC Name:

Fenspiride

Cas Number:

5053-06-5

Molecular formula:

C15H20N2O2

IUPAC Name:

8-(2-phenylethyl)-1-oxa-3,8-diazaspiro[4.5]decan-2-one

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

batch OP 030/04/GP1

Test organisms

Test organisms (species):

Daphnia magna

Study design

Test type:

static

Water media type:

freshwater

Total exposure duration:

48 h

Test conditions

Test temperature:

18°C to 22°C

pH:

7 to 9

Dissolved oxygen:

at least 60% of the air saturation value at the temperature

Nominal and measured concentrations:

0, 1, 10 and 100mg/L

Results and discussion

Effect concentrations

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The highest concentration without immobilization at 48h was 1mg/L.
The lowest concentration with 100% immobilisation at 48h was >100mg/L.
The CE50 at 24h and 48h were > 100mg/L