Ricinoleyl monomaleate triglyceride

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:

27-31 October 2000

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP study according to international guidelines but lacking analytical support for test concentrations.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

liquid: viscous

Details on test material:

Batch: T4649
Expiry date: 23 April 2001
Storage at 10 to 30 dC

Sampling and analysis

Analytical monitoring:

no

Test solutions

Vehicle:

yes

Details on test solutions:

Identity and concentration of auxiliary solvent for dispersal: Acetone 0.1 ml/l. A 60 g/L stock solution in acetone was prepared and dosed to a mixing vessel, which was continuously stiired and kept under ultra-sonic treatment to maintain a homogenous solution. This stock solution was then dosed to other mixing vessels to generate the lower test concentrations.

Test organisms

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Study design

Test type:

flow-through

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Test conditions

Hardness:

36 - 40 mg CaCO3/L

Test temperature:

13 - 14 dC

pH:

7.3 - 7.6

Dissolved oxygen:

8.5 - 9.6 mg O2/L

Nominal and measured concentrations:

nominal concentrations: 0.78, 1.3, 2.2, 3.6 and 6.0 mg/L

Details on test conditions:

10 fish per replicate, two replicates per test group including an untreated and a solvent control. Fish loading did not exceed 0.21 g/L. The flow of water through the vessels ranged between 69 - 74 L/d.

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 6 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: The functional water solubility limit was exceeded by the two highest test concentrations, 3.6 and 6.0 mg/L.

Effect concentrations 2

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

6 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: visual effects, appearance and swimming behaviour.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The test substance has proven to be non-toxic for fish at levels below, at and above its solubility in water.