[1,1'-Biphenyl]-2-carbonitrile, 4'-[(2-butyl-4-oxo-1,3-diazaspiro[4.4]non-1-en-3-yl)methyl]-

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:

16 July 1996 to 27 November 1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study; GLP compliance

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4'-((2-butyl-4-oxo-1,3-diazaspiro[4.4]non-1-ene-3-yl)methyl)(1,1'-biphenyl)-2-carbonitrile

EC Number:

604-075-6

Cas Number:

138401-24-8

Molecular formula:

C25H27N3O

IUPAC Name:

4'-((2-butyl-4-oxo-1,3-diazaspiro[4.4]non-1-ene-3-yl)methyl)(1,1'-biphenyl)-2-carbonitrile

Details on test material:

- Code of test material (as cited in study report): SR47563
- Chemical name:4’-[(2-butyl-4-oxo-1,3-diaza-spiro[4.4]non-1-en-3-yl)methyl]- biphenyl]-2-carbonitrile
- Physical state: white-beige powder
- Lot/batch No.: 6R00003
- Solubility: 1.3E-3 g/L at 23˚C
- Stability: stable under normal conditions of use
- Moll mass: 385.5
- Molecular formular: C25H27N3O
- Melting point: 97˚C

Sampling and analysis

Analytical monitoring:

yes

Test solutions

Vehicle:

no

Test organisms

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

Supplier: Pisciculture Exotique, Dourdan, France
Average length: 31 mm
Average wet weight: 0.26 g
No mortality during adaptation.
Batch-wise reference test with potassium dichromate: 24hLC50= 246 mg/L (historical interval: 200 - 400 mg/l)

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Post exposure observation period:

Not applied

Test conditions

Hardness:

250 ± 25 mg/l expressed as CaCO3

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 0.6 mg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 2

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

>= 0.6 mg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Any other information on results incl. tables

Sublethal observations / clinical signs:

The table below show the concentrations analysed during the limit testt with fish and the simulation test without fish. The results show that the initial concentration decreases significantly during the period of 96 h independent from the presence or absence of fish.

Further the simulation test show that the main decrease occurs during the first 24 h, probably due to stabilization of the test solution after filtration. After 24 h, the test solution is relatively stable during the following 72 h with concentrations measured decreasing by less than 20 %.

Table: Concentrations of the test substance measured in the limit test and the simulation test.

Analysed concentration (mg/L)
Time (h)	Limit test	Stability
0	1	0.9
24	-	0.62
48	-	0.55
72	-	0.53
96	0.53	0.53

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

No LC50 could be determined as no mortality or any other visible abnormalities were recorded in fish exposed to a saturated solution at an average actual concentration of 0.6 mg/L during 96 h. Although concentrations measured were not consistently stable during the test period, the substance appears to induce no acute effect on the survival of fish exposed to concentrations near its solubility in water (ca. 1 mg/L).