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Ecotoxicological information

Short-term toxicity to fish

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Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19 July 2004 to 28 January 2005.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
The test material was known to rapidly hydrolyse releasing butane-1,3-diol and ethyl acetoacetate.
Analysis of test preparations at 0, 24, 48 and 72 h showed ethyl acetoacetate and butane-1,3-diol were stable in the test solutions over the 24 h test-media renewal period.
The results of the test are based on nominal concentration of the parent test material.

Test solutions

Vehicle:
no
Details on test solutions:
The test material was known to rapidly hydrolyse releasing butane-1,3-diol and ethyl acetoacetate. These are water soluble, but the co-formed aluminium hydroxide is poorly soluble (1.5 mg/L at 20 °C), so the test material was filtered to remove solids that may have exerted a physical effect on the test organisms. The organic hydrolysis products were monitored during the conduct of the test by gas chromatography using external standards.
Analysis of test preparations at 0, 24, 48 and 72 h showed ethyl acetoacetate and butane-1,3-diol were stable in the test solutions over the 24 h test-media renewal period.
The results of the test are based on nominal concentration of the parent test material.

Test organisms

Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
Mean standard length 4.3 cm, weight 1.15 g.

Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h

Test conditions

Hardness:
100 mg/L as CaCO3
Test temperature:
14 °C
pH:
7.5 to 7.8
Dissolved oxygen:
> 10.0 mg O2/L
Salinity:
27 mg Cl/L
Conductivity:
439 uS/cm
Nominal and measured concentrations:
For ethyl acetoacetate, analysis at 0, 24, 48, and 72 h showed the concentration to be 67 to 79% of theoretical amount for 100% hydrolysis of the parent test material.
For butane-1,3-diol, analysis at 0, 24, 48, and 72 h showed the concentration to be 67 to 96% of theoretical amount for 100% hydrolysis of the parent test material.
Details on test conditions:
Following a preliminary range-finding test, fish were exposed in two groups of ten to an aqueous solution of the test material at a single concentration of 100 mg/L (expressed in terms of parent test material). Exposure was for 96 h at 14 °C under semi-static conditions. The number of mortalities and any sub-lethal effects were determined 3 and 6 hours after the start, and then daily throughout the test.
Reference substance (positive control):
no

Results and discussion

Effect concentrations
Key result
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
behaviour

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
LC50 (fish, 96 h) >100 mg/L. NOEC 100 mg/L.