Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
06 June 1992 - 14 August 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test was performed according to OECD test guidelines, and a statement of GLP compliance has been made.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
yes
Remarks:
The measured dissolved oxygen concentrations were below 60% ASV (air saturation value) during the study This minor deviation is not consiered to have effected the outcome of the study as no sub-lethal effects were observed during the study
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Di-trimethylolpropane, Di-TMP and 3,3,7,7-tetrahydroximethyl-5-oxanone (reported as ditrimethylolpropane in this summary)
- Lot/batch No.: 90128
- Stability under test conditions: 1% water solution stable for one week at 4ºC
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
Not applicable

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
Portions of stock and test solutions were sampled and delivered to the sponsor for analysis.

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Test solutions were prepared daily in aerated (>90%) dilution water
- Evidence of undissolved material (e.g. precipitate, surface film, etc): None recorded

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebra fish
- Source: received from the import quarantine.
- Weight at study initiation (mean and range, SD): 0.5g


ACCLIMATION
- Acclimation period: Fish were held in laboratory's internal quarantine for 14 days prior to commencement of the test.

Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
Not applicable

Test conditions

Hardness:
250±25 mg CaCO3/L.
Test temperature:
24±1ºC
pH:
Measured pH of fresh solutions were in the range 7.8 - 8.0
Measured pH of used (24 hour old) solutions were in the range 7.2 - 7.4
Dissolved oxygen:
Dilution water was aerated to saturation exceeding 90%.
Measured values in fresh solutions were in the range 97 - >100%
Used (24 hour old) solutions had values in the range 29 - 52%.
Measured dissolved oxygen levels below 60% of the air saturation value constitutes a guideline deviation. However, this minor deviation is not considered
Salinity:
Not applicable.
Nominal and measured concentrations:
0 mg/L (control) and 1000 mg/L (nominal concentration)
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: glass vessels, 5L.
- Aeration: before use the water was oxygenated
- Renewal rate of test solution (frequency/flow rate): test solutions were replaced every 24 hours.
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 1.0 grams of fish per litre.


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: dilution water preparation was consistent with the preparation described in OECD test guideline 203.



OTHER TEST CONDITIONS
- Photoperiod: light:dark 16:8 hours.
- Light intensity: not specified / normal laboratory illumination.


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Mortality

TEST CONCENTRATIONS
- Range finding study
- Results used to determine the conditions for the definitive study: the preliminary test demonstrated no treatment related mortality at 1000 mg/L.
Reference substance (positive control):
yes
Remarks:
potassium dichromate

Results and discussion

Effect concentrations
Duration:
96 h
Dose descriptor:
EC50
Effect conc.:
> 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
There was no mortality in either the control or the 1000 mg/L treatment.
Results with reference substance (positive control):
The sensitivity of the fish population used for potassium dichromate was 300 mg/L which is in accordance withe the Swedish Standard SS 02 81 62.
Reported statistics and error estimates:
Not applicable

Any other information on results incl. tables

The criteria for the validity of the test according to OECD 203 was fulfilled:

- constant conditions were maintained as far as possible throughout the test through semi-static procedures

- the mortality in the controls did not exceed 10% at the end of the test

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
A 96 hour acute semi-static limit toxicity study in zebra fish (Brachydanio rerio) was performed to assess the toxicity of
ditrimethylolpropane. The study was performed according to GLP and the OECD 203 Test Guideline. No mortalities were observed during the test, therefore the 96 hour LC50 was observed to be >1000 mg/L (the highest nominal concentration tested).
Executive summary:

A 96 hour acute semi-static limit toxicity study in zebra fish (Brachydanio rerio) was performed to assess the toxicity of

ditrimethylolpropane. The study was performed according to GLP and the OECD 203 Test Guideline. No mortalities were observed during the test, therefore the 96 hour LC50 was observed to be >1000 mg/L (the highest nominal concentration tested).