Registration Dossier

Diss Factsheets

Ecotoxicological information

Short-term toxicity to fish

Currently viewing:

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:
1989-10-18 to 1989-11-11
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
1984
Deviations:
yes
Remarks:
The study was performed without analytics.
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Version / remarks:
1984
Deviations:
yes
Remarks:
The study was performed without analytics.
GLP compliance:
yes
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: 1000 mg of the test item to 1 L of diluting water and subsequent stirring for 24 hours at room temperature to reach an equilibrium concentration of the test substance in the test substance in the test medium
- Eluate: diluting water
- Controls: yes
Test organisms (species):
Poecilia reticulata
Details on test organisms:
TEST ORGANISM
- Common name: Poecilia reticulata (guppy)
- Source: IOB (Instituut voor Onderzoek van Bestrijdingsmiddelen), Wageningen, The Netherlands
- Age at study initiation: > 4 weeks
- Length at study initiation: approximately 2 cm
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
13°dH
Test temperature:
22 - 26 °C
pH:
7.5 to 8.2
Dissolved oxygen:
5.9 to 7.8 mg/L
Nominal and measured concentrations:
- nominal concentration: 1000 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: 2 L covered glass aquaria which contained 1 L of the test medium
- Type (delete if not applicable): closed
- No. of organisms per vessel: 10 fishs in the control vessel and in the test vessel, whereas the duplicate test vessel contained 11 fishs
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.6 g biomas/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: a synthetic water, Dutch Standard Water according NPR 6507 (1980)
- Conductivity: less than 5 µS/cm
- Intervals of water quality measurement: Measurements of oxygen concentration were carried out on days 2 and 4, pH-measurements on days 0, 2 and 4. If a high mortality was observed on the other days, the oxygen concentrations and pH were measured then also.

OTHER TEST CONDITIONS
- Photoperiod: 12 hours per day

EFFECT PARAMETERS MEASURED: The surviving fish were counted daily and dead fish removed immediately upon observation.

TEST CONCENTRATIONS
- Range finding study: yes
- Test concentrations: 1, 10, 1000 mg/L
- Results used to determine the conditions for the definitive study: No mortality was observed.
Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
The fish survived in a saturated solution containing 1 g the test item /L for 96 hours. Binormal theory dictates that when 10 fish are used with 0 % mortality, there is a 99.9 % confidence that the LC50 (96 h) is greater than 1000 mg/L. However, given that during the test flakes of the test item remained visible at the bottom of the vessel, the LC50 should be handled with care.
No effects such as deviations in the behavior or appearance of the fish were not observed.
Validity criteria fulfilled:
yes
Conclusions:
The LC50 (96 h) of ditetradecyl peroxydicarbonate is greater than 1000 mg/L.
Executive summary:

Ditetradecyl peroxydicarbonate was tested in an acute toxicity test with Poecilia reticulata (guppy) under semi-static conditions in accordance with EU method C.1 and OECD guideline No. 203. The test was performed in duplicate. The fish survived for four days in a saturated solution which contained 1000 mg of the test substance/L. Binormal theory dicates that when 10 fish are used showing 0 % mortality, there is a 99.9 % confidence that the LC50 (96 h) is greater than 1000 mg/L. However, given that during the test flakes of the test substance remained visible at the bottom of the vessel, the LC50 value should be handled with care. No deviations in the behaviour or appearance of the fish were observed.

Description of key information

The LC50 (96 h) of ditetradecyl peroxydicarbonate is greater than 1000 mg/L.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Dose descriptor:
LC50
Effect concentration:
> 1 000 mg/L

Additional information

Key acute fish study


Ditetradecyl peroxydicarbonate was tested in an acute toxicity test with Poecilia reticulata (guppy) under semi-static conditions in accordance with EU method C.1 and OECD guideline No. 203. The test was performed in duplicate. The fish survived for four days in a saturated solution which contained 1000 mg of the test substance/L. Binormal theory dicates that when 10 fish are used showing 0 % mortality, there is a 99.9 % confidence that the LC50 (96 h) is greater than 1000 mg/L. However, given that during the test flakes of the test substance remained visible at the bottom of the vessel, the LC50 value should be handled with care. No deviations in the behaviour or appearance of the fish were observed.


 


Supporting FET study with the test item and structural analogue substance (CAS 26322-14-5)


The objective of this study was to screen the effects of the test item and its structural analogue substance (CAS 26322-14-5) for its effects on newly fertilized zebra fish eggs and hatchlings over an exposure period of 96 hours according to a simplified OECD 236 guideline. The intention was to demonstrate a similar range of effects in support of a read-across approach. Both, the target and the source substance are extremely poorly soluble, with solubility limits under or at the limits of the available analytical methods available. A 72 hour slow stir technique was therefore used to allow an extended period for the parent substances or resulting degradation products to equilibrate at their corresponding solubility limits. Such a water accommodated fraction approach is preferentially supported with chemical analysis in order to demonstrate exposure to the materials concerned. For the materials tested this was not possible. For this reason a daily refreshment regime was chosen to ensure a worst case exposure. Testing was otherwise conducted according to the OECD 236 guideline with daily observations with the modifications as indicated under test guideline modifications and deviations. Every 24 hours, observations were recorded. All atypical effects on the embryo in comparison to the controls were noted. At the end of the exposure period, acute toxicity was determined based on a positive outcome in any of the four apical observations as detailed in the OECD 236 guideline. The LC50 was then estimated where possible. For other observations there is as yet no finalized guidance on how to interpret any non-lethal findings from this assay. Other nonlethal findings were therefore recorded only at this stage. Previous work using the OECD 236 guideline for predicting the effects of organic peroxides on adult fish showed a good level of concordance with existing adult fish data. It was noted however during this work that, in order to provide a sufficiently conservative estimation of an adult fish LC50 non-lethal effects should ideally also be included in the prediction. For this reason fish considered to have severe malformations that would ultimately result in their death were considered dead in order to make the LC50 prediction for adult fish as worst case as possible. Acute toxicity is usually expressed as EC20,50,80 (Effect Concentration) values. The ECn values are the concentrations of the test substance showing n% reduction in survival relative to the controls. Depending on the test results obtained, the LOEC (Lowest Observed Effect Concentration) and NOEC (No Observed Effect Concentration) can also be determined. The LOEC is defined as the lowest tested concentration which survival is significantly reduced compared to the control. The NOEC is defined as the highest tested concentration at which survival shows no significant difference relative to the control. Endpoints are usually calculated using a validated statistical software program using the William’s and Trimmed Spearman-Karber / probit methods as appropriate. Dependent on the data generated statistical calculations cannot usually be carried out in screening studies due to the limited concentration range, in which case an estimation of the endpoint range has been made. In the event that the test substance is very poorly soluble, instable or a mixture, loading concentrations; Effect loading concentration (ELn) and No observed effect loading rate (NOELR) were used to express the toxicity.
The similar results observed when fish embryos and hatchlings were exposed to both substances is considered to support similar acute toxicity of both materials to adult Fish species. Read-across of the existing acute fish data is therefore considered justified. In addition the hydrolysis of both parent materials is also expected to occur in a similar way to Tetra and hexadecanol. Both are also of similar structure and limited solubility. The benefit of a WAF approach is such that test organisms are exposed to the soluble fractions of both parent and hydrolysis products. Work is ongoing to attempt quantification of Parent and /or degradation products to allow a better quantitative assessment of the effects.