Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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: 202-327-6 | CAS number: 94-36-0
- 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
Endpoint summary
Administrative data
Description of key information
Additional information
Relative to photolysis, three data are available concerning the potential phototransformation of Dibenzoyl peroxide. Nevertheless, no information is available in order to evaluate the relevance of these data. Based on these data, Dibenzoyl peroxyde may decompose due to photolysis. Consequently, in order to reach a conclusion concerning the degradation potential of Dibenzoyl peroxyde via photolysis, an experimental test has to be performed. Nevertheless, this information was not considered as crucial in order to assess the environmental risk of the substance. Therefore, no test is proposed at the moment in order to cover this issue.
The preliminary hydrolysis study showed that at pH 4, 7 and 9 and 50±0.5ºC, more than 50% hydrolysis had occurred after 2.4 hours, equivalent to a half-life of less than 1 day under environmental conditions (25°C). Benzoic acid, the expected main degradation product, was present in the hydrolysed solutions at each test pH. Dibenzoyl peroxide was thus determined to be hydrolytically unstable under acidic, neutral and basic conditions.
Consequently, when released into water, Dibenzoyl peroxide will rapidly be transformed into benzoic acid due to its instability. Nevertheless, the hazard assessment of this peroxide in water is not based on its degradation products in water (and particularly on the data relative to benzoic acid) because the half-life of parent substance is not sufficiently low to avoid toxic effects on the aquatic compartment organisms caused by the parent substance.
According to a new result of ready biodegradation obtained (Van Ginkel, 2015), Dibenzoyl peroxide should be classified as readily biodegradable. In addition, the PEC/PNEC ratio for water, sediment and soil compartments obtained in the exposure assessment of the substance are all below 1. Therefore, simulation testing on ultimate degradation in surface water (OECD 309), sediment simulation testing (OECD 308) and soil simulation testing (OECD 307) are waived in accordance with column 2 of Annex IX chapter 9.2 of Regulation EC 1907/2006. As mentioned in the REACH guidance on information requirements and chemical safety assessment Chapter R.11 on PBT/vPvB assessment (Version 2.0, November 2014, Figure R.11 -3), there is no reason to perform further biodegradation tests for the PBT/vPvB assessment when a substance is readily biodegradable. The conclusion is that Dibenzoyl peroxide does not fulfil the criteria for Persistence (P).
Conducting a study on bioaccumulation is scientifically not justified, because of the following:
1) Toxicokinetic results indicate that there is no risk of bioaccumulation of neither Dibenzoyl peroxide nor benzoic acid (see section 7.1.1 “Basic Toxicokinetics”).
Benzoyl peroxide is rapidly converted to benzoic acid in the skin of both animals and humans.Absorption of the benzoic acid occurs as benzoate through the blood vessels in the dermis. This metabolite enters the blood circulation and is rapidly cleared through the kidney (Nacht, S. et al, 1981; Yeung, D., et al, 1983; Morsches, B. and Holzmann, H., 1982; Wepierre, J., et al, 1986). Topically applied benzoyl peroxide penetrates unchanged through the stratum corneum or follicular openings of excised human skin and is converted metabolically to benzoic acid within the skin (Nacht S. et al, 1981). A study in rhesus monkeys in vivo showed that this benzoic acid is systemically absorbed as benzoate and rapidly excreted in the urine in an unchanged form, without being conjugated to hippuric acid, as would be predicted to occur following oral administration.
2) A computer simulation via EPI Suite TM (using an experimental log Kow of 3.2, coming from the Klimisch-1 -rated study (2009), see section 4.7 “Partition coefficient”) resulted in a BCF for dibenzoyl peroxide equal to 60 L/kg wet-wt, which is far below the trigger value of BCF = 500 for classification with respect to chronic aquatic toxicity (see attached EPI Suite TM printout file).
Bioaccumulation Estimates (BCFBAF v3.00):
Log BCF from regression-based method = 1.778 (BCF = 60.03 L/kg wet-wt)
Log Biotransformation Half-life (HL) = -0.5728 days (HL = 0.2674 days)
Log BCF Arnot-Gobas method (upper trophic) = 1.823 (BCF = 66.58)
Log BAF Arnot-Gobas method (upper trophic) = 1.823 (BAF = 66.59)
log Kow used: 3.20 (user entered)
Based on the available information it is therefore proposed that the study on bioaccumulation of Dibenzoyl peroxide and its degradation substance can be waived, which is in accordance to the intention of the REACH regulation to minimize animal consumption by conducting unnecessary vertebrate studies.
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.