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EC number: 223-356-0 | CAS number: 3851-87-4
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2012-03-20 to 2012-03-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Valid without restriction; GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Bis(3,5,5-trimethylhexanoyl)peroxide
- IUPAC Name:
- Bis(3,5,5-trimethylhexanoyl)peroxide
- Reference substance name:
- Bis(3,5,5-trimethylhexanoyl) peroxide
- EC Number:
- 223-356-0
- EC Name:
- Bis(3,5,5-trimethylhexanoyl) peroxide
- Cas Number:
- 3851-87-4
- Molecular formula:
- C18H34O4
- IUPAC Name:
- 3,5,5-trimethylhexanoyl 3,5,5-trimethylhexaneperoxoate
- Details on test material:
- - Name of test material (as cited in study report): Peroxan NPO; Bis(3,5,5-trimethylhexanoyl)peroxide
- Substance type: organic peroxide
- Physical state: liquid
- Analytical purity: 75 % (iodometric titration)
- Composition of test material, percentage of components: 75 % Peroxan NPO, 25 % Isododecane
- Lot/batch No.: 10618310
- Expiration date of the lot/batch: 2012-04-20
- Storage condition of test material: -8 to 0°C, protected from light
Constituent 1
Constituent 2
Test animals
- Species:
- other: reconstituted three-dimensional human skin model EpiDerm (MatTek)
- Strain:
- other: not applicable
- Details on test animals or test system and environmental conditions:
- Test system:
The test was carried out with the reconstituted three-dimensional human skin model EpiDermTM (MatTek). It consists of non-cancerous, human-derived epidermal keratinocytes (NHEK) which have been cultutred to form a multi-layered, highly differentiated model of the human epidermis. The NHEK are cultured are cultured on chemically modified, collagen-coated cell culture inserts (Millicell). The test systewm exhibits in vivo like morphological and growth characteristics and consists of organised basal, spinous, granular and cornified layers analogous to those found in vivo.
Test system
- Type of coverage:
- other: not applicable
- Preparation of test site:
- other: not applicable
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: EpiDerm Tissue was treated with distilled water and 8 N KOH
- Amount / concentration applied:
- The test item was applied undiluted. 50 µl of the test item were dispensed directly onto the EpiDerm tissue. The test item was spread to match size of the tissue.
- Duration of treatment / exposure:
- 3 minutes and 60 minutes exposure
- Observation period:
- n.a.
- Number of animals:
- n.a.
- Details on study design:
- see "any other information on materials and methods incl. tables"
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min
- Value:
- 90
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 min
- Value:
- 83
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
In vivo
- Other effects:
- n.a.
Any other information on results incl. tables
Table1: 3 min Exposure
Name |
Negative Control |
Test item |
Positive control |
|||
Tissue |
1 |
2 |
1 |
2 |
1 |
2 |
Absolute OD550-Werte |
2.080 |
2.087 |
1.959 |
1.787 |
0.309 |
0.269 |
2.082 |
2.088 |
1.962 |
1.784 |
0.315 |
0.271 |
|
2.068 |
2.061 |
1.945 |
1.770 |
0.312 |
0.269 |
|
Mean OD550 |
2.077 |
2.079 |
1.955 |
1.780 |
0.312 |
0.270 |
SD |
0.008 |
0.015 |
0.009 |
0.009 |
0.003 |
0.001 |
Total mean OD550(mean of two replicate tissues) |
2.078* |
1.868 |
0.291 |
|||
Mean relative tissue viability [%] |
100 |
90 |
14** |
|||
Mean inter tissue viability difference [%]*** |
0.1 |
9.4 |
14.5 |
* mean OD550 ≥ 0.8
** mean relative tissue viability of the 3 min positive control ≤ 30 %
*** inter tissue viability difference ≤ 30 %
Table 2: 60 min Exposure
Name |
Negative Control |
Test item |
Positive control |
|||
Tissue |
1 |
2 |
1 |
2 |
1 |
2 |
Absolute OD550-Werte |
1.955 |
1.763 |
1.815 |
1.454 |
0.114 |
0.119 |
1.983 |
1.790 |
1.692 |
1.376 |
0.117 |
0.129 |
|
2.000 |
1.782 |
1.706 |
1.361 |
0.115 |
0.121 |
|
Mean OD550 |
1.979 |
1.778 |
1.706 |
1.361 |
0.115 |
0.121 |
SD |
0.023 |
0.014 |
0.067 |
0.050 |
0.002 |
0.005 |
Total mean OD550(mean of two replicate tissues) |
1.879* |
1.567 |
0.119 |
|||
Mean relative tissue viability [%] |
100 |
83 |
6 |
|||
Mean inter tissue viability difference [%]*** |
10.7 |
21.7 |
6.4 |
* mean OD550 ≥ 0.8
*** inter tissue viability difference ≤ 30 %
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In this study the test item Peroxan NPO is not considered to be corrosive.
- Executive summary:
The potential of the test item to induce skin corrosion was analysed by using the three dimensional human skin model EpiDerm, comprising a reconstructed epidermis with a functional stratum corneum. Peroxan NPO was applied topically to the EpiDerm tissue for 3 min and 60 min, respectively followed by immediate determination of cytotoxic effects via MTT reduction assay.
The test item showed no corrosive potential. The mean relative tissue viability (% negative control) was >= 50% (90%) after 3 min treatment and >= 15% (83%) after 60 min treatment.
The controls confirmed the validity of the study. The mean OD550 of the two negative control tissues was >= 0.8 for each exposure period. The mean relative tissue viability of the positive control was =< (14%) after 3 min treatment. The maximum inter tissue difference of replicate tissues of all dose groups was =< 30 % (0.1%-21.7%).
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