Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 247-955-1 | CAS number: 26748-41-4
- 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

Biodegradation in soil
Administrative data
Link to relevant study record(s)
- Endpoint:
- biodegradation in soil: simulation testing
- Data waiving:
- exposure considerations
- Justification for data waiving:
- the study does not need to be conducted because direct and indirect exposure of soil is unlikely
- Justification for type of information:
- The performance of a study on biodegradation in soil was considered scientifically not justified.
REACH Regulation No. 1907/2006, Annex IX, Sect. 9.2.1.3, Col. 2, states as follows: “9.2.1.3: The study need not to be conducted: - if the substance is readily biodegradable, or - if direct and indirect exposure of soil is unlikely. ”
Direct and indirect exposure of the test item to soil is highly unlikely. Due to the unstable nature of organic peroxides, it can be assumed that upon contact with water and organic matter, the test item undergoes rapid degradation resulting in the formation of respective alcohols and acids. Hydrolysis half-life of TBPND was determined to be < 24 or even 12 h at 20 °C. Therefore, an abiotic degradation of the test item in the environment is expected.
In addition, TBPND is considered as inherently biodegradable based on a Closed Bottle Test according to OECD 301 D (26 % degradation after 28 days, 53 % after 140 days, please refer to IUCLID section 5.2.1). New data for other peroxyesters were recently generated. Those revealed that surface water does not change the degradation products or behavior compared to hydrolysis studies in water/buffer. It is therefore proposed to first invest more in clarifying the biodegradation potential of the compound before considering a simulation test.
For this reason a new prolonged closed bottle test was initiated. Preliminary results of a non-GLP enhanced closed bottle test revealed 65 % degradation after 28 days. In ready biodegradability tests, the time window concept has been introduced as a simple alternative to quantify the rate of biodegradation. However, this concept is only applicable and valid for single water-soluble chemical substances. TBPND is a chemical in which two moieties are linked together. Upon hydrolysis tert-butanol and 7,7-dimethyloctanoic acid require the concerted action of at least two microorganisms as a single organism usually lacks the full complement of enzymatic capabilities. It can be expected that those two moieties usually do not have identical lag periods. Instead, sequential degradation is the case. Biodegradation curves of peroxyesters, such as TBPND, should therefore not be used to assess a 10- or 14- day effect.
The new data on biodegradation will be included in the dossier as soon as the GLP compliant study is concluded and study report is available. A second test with the respective hydrolysis product (neo¬decanoate, UVCB) will be performed depending on the outcome of the first test, as the data for the registered mono-constituent neodecanoic acid are not applicable and sufficient data for tert-butanol are available. Depending on the outcome in a second step a Zahn-Wellens test is foreseen as positive results for other organic peroxides were noted. According to ECHA Guidance on Information Requirements and Chemical Safety Assessment Chapter R11: PBT/vPvB Assessment inherent biodegradability of a substance is proof enough for considering the substance as not P or vP. Based on preliminary results, TBPND could even be considered as readily biodegradable.
Further, Environmental Risk Assessment revealed safe use of the substance throughout its whole life cycle due to very low exposure of the soil compartment which is especially based on the following facts:
Chemicals can reach the soil via several routes:
1. Application of sewage sludge in agriculture. Organic peroxides, when released into the sewage of a plant production or a downstream user’s plant, are treated with other substances in dedicated sewage treatment plants. The activated sludge stemmed from these sewage treatment plants are then extracted and treated as chemical waste. From the production plant, the release of organic peroxide into the sewage is very limited, not to say completely negligible. The waste water from production plant can be treated on site (at least a physical/chemical treatment, which will neutralize potential residual organic peroxide), which is usually followed by a biological treatment. So it is expected that organic peroxides are not present in sludge. Regarding the rest of the lifecycle, organic peroxides are mainly used as cross-linking agent/polymerization initiator for the production of resins/rubbers/polymers. Based upon the fact that organic peroxides are totally consumed during the process (>99%, which is confirmed by the release factor to sewage for curing agents from ESD n°3), the soil is not exposed to organic peroxides via use of sludge. As a consequence, soil is not exposed to organic peroxides via the application of sewage sludge in agriculture.
2. Direct application of chemicals. Based on the uses inventoried for organic peroxides there is no direct application of these substances on the soil compartment. Indeed, all uses are within industrial settings.
3. Deposition from the atmosphere. Deposition from the atmospheric compartment involves volatilization, vaporization or direct release of a considered substance into the atmosphere. Due to their dangerous intrinsic physico-chemical properties, organic peroxides are carefully handled in (semi-)closed systems and their transport, production and use are ruled by several regulations. This is also in line with the release factor to atmosphere for curing agents from ESD n°3. Based on organic peroxides uses, deposition on soil from the atmosphere is also not expected.
Based on these arguments exposure to the soil compartment is considered highly unlikely.
In conclusion, biodegradation testing in soil is considered not scientifically justified since exposure to this compartment is considered unlikely as outlined above according to REACH Regulation No. 1907/2006, Annex IX, Sect. 9.2.1.3, Col. 2. Further, the chemical safety assessment does not indicate the need to further investigate the degradation properties of the substance since the substance is inherently biodegradable and thus not considered to be P or vP. Therefore, further testing on P or vP properties in regards to PBT or vPvB assessment is also not applicable.
Reference
Description of key information
The performance of tests for biodegradation in soil is scientifically unjustified.
REACH Regulation No. 1907/2006, Annex IX, Sect. 9.2.1.3, Col. 2, states as follows:
“9.2.1.3: The study need not to be conducted:
-if the substance is readily biodegradable, or
-if direct and indirect exposure of soil is unlikely. ”
Direct and indirect exposure of the test item to soil is highly unlikely. Due to the unstable nature of organic peroxides, it can be assumed that upon contact with soil and organic matter, the test item undergoes rapid degradation resulting in the formation of respective alcohols and acids. Furthermore, TBPND was considered to be inherently biodegradable, therefore simulation testing for biodegradation in sediment was considered not scientifically justified.
Key value for chemical safety assessment
Additional information
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.

Route: .live2