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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study; well documented study report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
yes
Remarks:
During the second study the pH values exceeded the proposed range of 6.0-8.5 i.e. occasionally pH ranged up to 8.6. During the study the temperature of the medium ranged up to 19C.
GLP compliance:
yes

Test material

Constituent 1
Details on test material:
- Lot/batch No.: Mix 51785
-Stable under storage conditions
- Storage condition of test material: At room temperature in the dark

Sampling and analysis

Analytical monitoring:
no

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Test concentrations were prepared by adding quantitatively 274.3 and 272.6 mg to two vessels with 27 litres of tap-water. These solutions were stirred for 24 hours.
- Controls: Test medium without test substance or other additives

Test organisms

Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Common name: Rainbow trout
- Strain: Salmo gairdneri, Teleostei, Salmonidae
- Source: Forellenhof, Beek, the Netherlands
- Length at study initiation (length definition, mean, range and SD): 7.5 cm
- Weight at study initiation (mean and range, SD): 5.2 g
-No feeding from 24 hours prior to the start of the test and throughout exposure
ACCLIMATION
- Acclimation period: at least 12 days
- Acclimation conditions (same as test or not): in 200 liter aquaria
- Type and amount of food: Trouvite 00
- Feeding frequency: Once a day

Study design

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

Test conditions

Hardness:
2.33 mmol/L
Test temperature:
15 - 19 C
pH:
7.2 - 8.5 with occasional values of 8.6
Dissolved oxygen:
> 5 mg/L
Nominal and measured concentrations:
Nominal-10 mg/l (oversaturated)
Details on test conditions:
TEST SYSTEM
- Material, size, headspace, fill volume: UV-sealed glass, 27 litres
- Aeration: Yes- continuously
- No. of organisms per vessel: 10
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: tap-water
OTHER TEST CONDITIONS
- Photoperiod: 14 hours photoperiod daily
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
-Rate of mortality was assessed at 4, 24, 48, and 96 hours
Reference substance (positive control):
no

Results and discussion

Effect concentrations
Duration:
96 h
Dose descriptor:
EC50
Effect conc.:
> 10 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks:
exceeding solubility
Details on results:
- Other adverse effects control: One fish had haemorrhage of the gills.

Any other information on results incl. tables

Sublethal observations / clinical signs:

Chemical analysis revealed that due to the very low solubility of the test material in water and interference of compounds present in tap-water with the analysis, no detectable levels of the test material could be recorded. Therefore it was decided not to perform analysis of test concentration during the final test.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
Under the conditions of this study the 96 hour LC50 in rainbow trout was greater than the saturated concentration of the test material when tested as an oversaturated solution of 10 mg/L.
Executive summary:

Ten fish per concentration were exposed for 96 hours in a static system to an oversaturated concentration of 10 mg/l of the test material in tap-water. After 96 hours of exposure no mortality was observed, The 96 hour LC50 in rainbow trout was greater than the saturated concentration of the test material when tested as an oversaturated solution of 10 mg/L.