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Ecotoxicological information

Short-term toxicity to fish

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Administrative data

Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16-10-1995 to 10-11-1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The study is performed according to GLP and OECD 203 guideline but no specific chemical analysis was performed and the substance is insoluble in water. No stable emulsions could be prepared and after preparation of the test solutions the remaining undissolved substance was removed using a folding filter. Due to the strong sorbing properties of the test substance the use of the filter might have reduced the exposure concentration below the water solubility. The results are summarily described, no raw data are included in the report and no information on the purity of the test substance is given but as this is a fish study and acute fish studies are probably not critical for the hazard assessment the result will be used.
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
yes
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
testsubstance is added to a bekerglass en tapwater is added. Then, with the use of Ultra Turrax the suspension is homogenisized and added to a 10L glass container where it is diluted with tapwater and stirred for 72h with magentic stirring. The solution was filtered over a folding filter and the filtrate was clear and used for the tests.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
source: Hamilton-Buchanan
size 3.1-3.4 cm (mean = 3.4) which is outside the recommended range of 2 plus minus 1 cm.
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Test temperature:
21.0-21.8 deg C
pH:
7.6-8.3
Dissolved oxygen:
5.8-9.7
Nominal and measured concentrations:
nominal: 100, 220, 500, 1000 mg/L
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
220 - 500 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
no data
Reported statistics and error estimates:
no data
Validity criteria fulfilled:
not specified
Conclusions:
The reliability of this study is low: The study is performed according to GLP and OECD 203 guideline but no specific chemical analysis was performed and the substance is insoluble in water. No stable emulsions could be prepared and after preparation of the test solutions the remaining undissolved substance was removed using a folding filter. Duo to the strong sorbing properties of the test substance the use of the filter might have reduced the exposure concentration below the water solubility.
The study report is not complete:

No raw data are included in the report and no information on the purity of the test substance is given. These points make the actual exposure uncertain en therefore the study is ranked 3.
Executive summary:

The toxicity of distearyl amine (Genamine SH 200) to zebrafish was determined according to OECD guideline 203 applying GLP conditions. The test substance is poorly soluble in water and no stable dispersions could be prepared. The remaining undissolved test substance was removed by filtration over a folding filter. Due to the sorptive properties a large fraction of the substance might be sorbed to the filter. It is therefore unclear to what concentration the test organisms were exposed.

Description of key information

Due to the limited solubility of test substance an effect range is reported of 220 - 500 mg/L.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
220 mg/L

Additional information

The short-term toxicity fish tests available was conducted in a period when no reliable specific method of analyses was available. The concentrations were therefore not analytically verified, the reliability of the results is limited because of the poor solubility of the test substances and partial sorption onto the walls of test vessels. Hence, most of the tests were considered to be valid with restrictions.