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EC number: 213-147-2 | CAS number: 927-07-1
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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Biodegradation in water: screening tests
Administrative data
Link to relevant study record(s)
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018-05-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 D (Ready Biodegradability: Closed Bottle Test)
- Version / remarks:
- 1992
- Deviations:
- yes
- Remarks:
- Please refer to "Principles of method"
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.4-E (Determination of the "Ready" Biodegradability - Closed Bottle Test)
- Version / remarks:
- 1992
- Deviations:
- yes
- Remarks:
- Please refer to "Principles of method"
- Qualifier:
- according to guideline
- Guideline:
- ISO 10707 Water quality - Evaluation in an aqueous medium of the "ultimate" aerobic biodegradability of organic compounds - Method by analysis of biochemical oxygen demand (closed bottle test)
- Version / remarks:
- 1994
- Deviations:
- yes
- Remarks:
- Please refer to "Principles of method"
- Qualifier:
- according to guideline
- Guideline:
- other: Revised introduction to the OECD guidelines for testing of chemicals, section 3, Part 1: Principles and strategies related to the testing of degradation of organic chemicals, Paris Cedex, France.
- Version / remarks:
- 2006
- Deviations:
- no
- Principles of method if other than guideline:
- Slight modifications to the guidelines:
a) ammonium chloride was omitted from the medium to prevent oxygen consumption due to nitrification (omission does not result in nitrogen limitation as shown by the biodegradation of the reference compound)
b) river water instead of an effluent/extract/mixture was used as inoculum. - GLP compliance:
- yes (incl. QA statement)
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- natural water: freshwater
- Details on inoculum:
- - Source of inoculum:
River water was sampled from the Rhine near Heveadorp, The Netherlands (08-02-2018). The nearest plant (Arnhem-Zuid) treating domestic wastewater biologically was 3 km upstream. - Duration of test (contact time):
- 28 d
- Initial conc.:
- 2 mg/L
- Parameter followed for biodegradation estimation:
- O2 consumption
- Details on study design:
- TEST CONDITIONS
- Composition of medium:
10 bottles containing river water only
10 bottles containing river water and silica gel
10 bottles containing silica gel with test item
6 bottles containing silica gel and the reference substances (sodium actetate)
10 bottles containing silica gel only
- Additional substrate: The river water used in the Closed Bottle test was spiked per liter of water with 8.5 mg KH2PO4, 21.75 mg K2HPO4, 33.4 mg Na2HPO4·2H2O, 22.5 mg MgSO4·7H2O, 27.5 mg CaCl2, 0.25 mg FeCl3·6H2O. Ammonium chloride was not added to the river water to prevent nitrification.
- Solubilising agent: not applicable
Accurate administering of the test substance was accomplished by preparing a solid stock of 3.0 mg of the test substance per g of silica gel in a 50-mL serum flask. Only part of the top layer of the silica gel was brought into contact with the test substance. The serum flask was closed with a screw top and the content was mixed vigorously. Subsequently, 0.20 g of silica gel with the test substance was added to the test bottles. The resulting concentration of test substance in the bottles was 2.0 mg/L. Next the bottles were filled with nutrient medium with inoculum and closed. The reference substance (sodium acetate) was added to the bottles using a stock solution of 1.0 g/L.
- Test temperature: 22.7 - 23.0 °C
- pH: 8.0
- pH adjusted: no
- Aeration of water: Each of the prepared solutions was dispensed into the respective group of BOD bottles so that all bottles were completely filled without air bubbles.
- Suspended solids concentration: River water without particles was used as inoculum. The particles were removed by sedimentation after 1 day while moderately aerating.
- Continuous darkness: yes
TEST SYSTEM
- Culturing apparatus: 0.30 L BOD bottles with glass stoppers
- Number of culture flasks/concentration: 10 per group; test item concentration was 2.0 mg/L
- Method used to create aerobic conditions: The river water was aerated for 7 days before use to reduce the endogenous respiration (van Ginkel and Stroo, 1992).
SAMPLING
- Sampling: Two duplicate bottles of all series were withdrawn for analyses of the dissolved oxygen concentration at day 7, 14, 21, and 28
CONTROL AND BLANK SYSTEM
- Inoculum blank: yes
- Abiotic sterile control: no
- Toxicity control: yes
- Other: Reference substance (sodium acetate) - Reference substance:
- acetic acid, sodium salt
- Key result
- Parameter:
- % degradation (O2 consumption)
- Value:
- 61
- Sampling time:
- 28 d
- Results with reference substance:
- 87 % at day 14
- Validity criteria fulfilled:
- yes
- Interpretation of results:
- readily biodegradable
- Conclusions:
- Under the conditions of this study, the test item was biotically degraded by 61 % after 28 d. Therefore, the test item is considered readily biodegradable.
- Executive summary:
In order to assess the biotic degradation of tert-butyl peroxypivalate, a ready biodegradability test was performed which allows the biodegradability to be measured in an aerobic aqueous medium. The ready biodegradability was determined in the Closed Bottle test performed according to slightly modified OECD, EU and ISO Test Guidelines, and in compliance with the OECD principles of Good Laboratory Practice.
tert-Butyl peroxypivalate did not cause a reduction in the endogenous respiration at day 7. The test substance is therefore considered to be non-inhibitory to the inoculum. tert-Butyl peroxypivalate was biodegraded by 61 % at day 28 in the OECD 301D Closed Bottle test. The substance should therefore be classified as readily biodegradable. Moreover, in the prolonged Closed Bottle test, the test item was biodegraded by 76 % at day 42.
The test is valid as shown by an endogenous respiration of 1.1 mg/L and by the complete degradation of the reference compound, sodium acetate. Sodium acetate was degraded by 80 % of its theoretical oxygen demand after 14 days. Finally, the most important criterion was met by oxygen concentrations >0.5 mg/L in all bottles during the test period.
Reference
Theoretical oxygen demand (ThOD)
The theoretical oxygen demand (ThOD) of the active ingredient of test substance is 2.2 g O2/g active ingredient. The ThOD of sodium acetate is 0.8 g/g.
Toxicity
Inhibition of the degradation of a well-degradable compound, e.g. sodium acetate by the test substance in the Closed Bottle test was not determined because possible toxicity of tert-butyl peroxypivalate to microorganisms degrading acetate is not relevant. Inhibition of the endogenous respiration of the inoculum by the test substance at day 7 was not detected (Table I). Therefore, no inhibition of the biodegradation due to the "high" initial test substance concentration is expected.
Test conditions
The pH of the media was 8.0 at the start of the test. The pH of the medium at day 28 was 8.0 (test and controls). The temperature ranged from 22.6 to 23.0 °C which is within the prescribed temperature range of 22 to 24 °C.
Validity of the test
The validity of the test is demonstrated by an endogenous respiration of 1.1 mg/L at day 28 (Table I). Furthermore, the differences of the replicate values at day 28 were less than 20 %. The biodegradation percentage of the reference compound, sodium acetate, at day 14 was 87 (Table II and Figure). Finally, the validity of the test is shown by oxygen concentrations >0.5 mg/L in all bottles during the test period.
Biodegradability
tert-Butyl peroxypivalate was biodegraded by 61 % at day 28 in the Closed Bottle test (Table II). Moreover, in the prolonged Closed Bottle test, the test item was biodegraded by 76 % at day 42The time-day window concept assumes that biodegradation of a single organic compound in a ready biodegradability test is a growth-linked process which follows an S-shaped growth curve. tert-Butyl peroxypivalate is a substance which may be regarded as consisting of two chemicals linked together by a peroxide bond. Upon hydrolysis two compounds are formed i.e. pivalate and tert-butanol. The biodegradation kinetics (lag period, growth rate, and yield) of the individual hydrolysis products are not necessarily the same. The biodegradation of the peroxide is an addition of different biodegradation curves. It is thus possible that individual compounds meet the time window criterion whereas the biodegradability curve of the peroxide suggests that the test substance is not readily biodegradable. The time window that can be applied to Closed Bottle tests is therefore not considered applicable, even though it is met. Over 60 % biodegradation was achieved in a period of approximately 12 days immediately following the attainment of 10% biodegradation after 9 to 10 days, therefore fulfilled the 14-day time window (10-day time window for other OECD 301 tests) criterion for ready biodegradable substances. The time window is therefore not considered applicable to tert-butyl peroxypivalate (OECD, 2006). tert-Butyl peroxypivalate should be classified as readily biodegradable.
Table 1 Oxygen consumption (mg/L) and the percentages biodegradation of the test substance, tert-Butyl peroxyneodecanoate (BOD/ThOD) and sodium acetate (BOD/ThOD) in the Closed Bottle test.
Time (days) | Oxygen consumption (mg(L) | Biodegradation | ||
Test substance | Acetate | Test substance | Acetate | |
0 | 0.0 | 0.0 | 0 | 0 |
7 | 0.0 | 3.8 | 0 | 70 |
14 | 0.8 | 4.3 | 24 | 80 |
21 | 2.0 |
| 61 |
|
28 | 2.0 |
| 61 |
|
42 | 2.5 |
| 76 |
|
Description of key information
Under the conditions of a closed bottle test according to OECD 301D (2018), the test item was biotically degraded by 61 % after 28 days. Therefore, the test item is considered readily biodegradable.
Key value for chemical safety assessment
- Biodegradation in water:
- readily biodegradable
- Type of water:
- freshwater
Additional information
In order to assess the biotic degradation of tert-butyl peroxypivalate, a ready biodegradability test was performed which allows the biodegradability to be measured in an aerobic aqueous medium. The ready biodegradability was determined in the Closed Bottle test performed according to slightly modified OECD, EU and ISO Test Guidelines, and in compliance with the OECD principles of Good Laboratory Practice.
tert-Butyl peroxypivalate did not cause a reduction in the endogenous respiration at day 7. The test substance is therefore considered to be non-inhibitory to the inoculum. tert-Butyl peroxypivalate was biodegraded by 61 % at day 28 in the OECD 301D Closed Bottle test. The substance should therefore be classified as readily biodegradable. Moreover, in the prolonged Closed Bottle test, the test item was biodegraded by 76 % at day 42.
The test is valid as shown by an endogenous respiration of 1.1 mg/L and by the complete degradation of the reference compound, sodium acetate. Sodium acetate was degraded by 80 % of its theoretical oxygen demand after 14 days. Finally, the most important criterion was met by oxygen concentrations >0.5 mg/L in all bottles during the test period.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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