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EC number: 243-424-3 | CAS number: 19910-65-7
- 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 irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was conducted from 1 May 2018 to 4 May 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- other: Preliminary unaudited data
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- 29 July 2016
- Deviations:
- yes
- Remarks:
- see Principles of method if other than guideline
- Principles of method if other than guideline:
- Deviations:
1. On 2 May 2018, there was a power failure at the Testing Facility. The power was restored around 7:30 am. The temperatures of the Kenmore and Thermo Scientific Freezer were between +2ºC to -4ºC at 7:42 am. This is a deviation from SOP0513.R7 that specifies acceptable freezer temperatures as -20±5ºC. This deviation affected storage conditions of any reagents stored at -20±5ºC. The temperature was in range (-16oC) at 10:14 am. The temperatures of the Fridgidaire, VWR, and Thermo Scientific refrigerators were between 9 to 10ºC at 7:41 to 7:43 am. This power failure affected storage conditions of any tissues and reagents stored at 2-8ºC. The responses of the assay positive and negative control were in line with the historical ranges at IIVS. Therefore, the deviations are not considered to have adversely affected the accuracy of the study.
2. On 2 May 2018, there was a power failure. The power was restored around 7:30 am. The temperatures of the Thermo Scientific Freezer were between +2ºC to -4ºC at 7:42 am. This is a deviation from SOP0513.R7 that specifies acceptable freezer temperatures as -20±5ºC. This deviation affected storage conditions of the test article included in this study and stored at -20±5ºC. The temperature was in range (-16oC) at 10:14 am. The Sponsor was informed of the power outage and was asked whether the test article can be used for testing. The Sponsor shared that storage at 2oC for 8 hours would have lost only 0.03% of the substance based on kinetic equation for thermal decomposition. Therefore, the Sponsor advised that the test material can be used for testing. The data analysis showed comparable responses of the tissues to the test article treatment at both exposure times. The deviation is not considered to have an adverse effect on the study quality and integrity.
3. The protocol states that to test for residual test article-mediated MTT reduction, two killed tissues will be treated with the positive control or test article concurrently with the viable tissues. During the study conduct, a significant difference in the MTT reduction on the second killed control tissue treated with the assay positive control for 3 minutes (raw OD550 value of 0.115 vs. 0.341 for the duplicate tissue). Therefore, another killed control experiment was conducted in the same day using duplicate tissues from the same lot. The raw OD550 values for the additional killed control tissues included in the study were 0.339 and 0.411, respectively, and comparable with the historical results. Under the circumstances, only the 3 OD550 corrected values for the 3 minutes killed control positive control that were comparable with historical values were averaged. The deviation is not considered to have an adverse impact on the study accuracy. - GLP compliance:
- yes
Test material
- Reference substance name:
- Bis-sec-butyl peroxydicarbonate
- EC Number:
- 243-424-3
- EC Name:
- Bis-sec-butyl peroxydicarbonate
- Cas Number:
- 19910-65-7
- Molecular formula:
- C10H18O6
- IUPAC Name:
- 2-[({[(butan-2-yloxy)carbonyl]peroxy}carbonyl)oxy]butane
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
-Source and lot/batch No of test material: Sponsor Lot No. 17121B3105
-Expiration date of the lot/batch:27 November 2018
Purity test date:10 February 2018
Purity:99.3%
Appearance:Clear colorless non-viscous liquid
Storage condition of test material:-15 to -25 degrees celcius
In vitro test system
- Test system:
- human skin model
- Remarks:
- human reconstructed skin
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from a single donor
- Source strain:
- other: Contact manufacturer-MatTek
- Details on animal used as source of test system:
- N/A
- Justification for test system used:
- See guideline
- Details on test system:
- The EpiDerm™ Model (EPI-200) (MatTek Corporation, Ashland, USA) that is used in this study
consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multi
layered, highly differentiated model of the human epidermis. It consists of organized basal, spinou
s and granular layers, and a multilayered stratum corneum containing intercellular lamellar lipid l
ayers arranged in patterns analogous to those found in vivo. The EpiDerm™ Model incorporates
several features which make it advantageous in the study of potential dermal corrosivity. First, the
test system uses a serum-free medium which eliminates the possibility of serum protein and test
article interaction (Shopsis and Eng, 1988). Secondly, the target cells are epithelial, derived from
human skin (Cannon et al., 1994). Third, since the tissue has a functional stratum corneum, the test
materials are applied directly to the tissue surface, at air interface, so that undiluted and/or end use
dilutions can be tested directly (Harbell et al., 1994). - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- Neat
- Duration of treatment / exposure:
- 3 mins and 60 mins
- Duration of post-treatment incubation (if applicable):
- N/A
- Number of replicates:
- 2 per exposure time
Test system
- Type of coverage:
- other: Topical
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 experiment
- Value:
- 36.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: 3 min tissue vialbilty=83.0% and 60 minutes tissue viability = 36.9%
- Other effects / acceptance of results:
- CRITERIA FOR DETERMINATION OF A VALID TEST
The assay will be accepted if the following criteria are met: 1) the positive control results in a corrosive
classification (i.e., <50% cell viability compared to negative controls, after a 3-minute exposure, and/
or <15% after a 60-minute exposure). 2) the mean OD550 value of the negative control tissues is ≥
0.8 and < 2.8.
Any other information on results incl. tables
The test article Di-sec-butyl peroxydicarbonate was tested in the EpiDerm™ Corrosivity Assay. Two
tissues were used to assess viability after a 3-minute exposure, and two tissues were used to assess
viability after a 60-minute exposure. Negative and positive controls were tested in parallel. Table 1
summarizes the mean % viability results for the test article and the positive control. The raw and analyzed
data are presented in attached report. The classification of the positive control, 8N KOH, was determined
to be corrosive thereby meeting the acceptance criterion.
The positive control, 8N potassium hydroxide (8N KOH), is known to directly reduce MTT in the absence
of viable cells. Therefore, a killed-control experiment was performed. The results of the killed control
experiment showed that there was significant direct MTT reduction in the positive control-treated killed
controls. Additional calculations were performed to correct for the amount of MTT reduced directly by
the positive control residues as described in the Presentation of Data section.
The test article as not determined to be a colorant (was not considered to have potential interference
with the MTT measurement) and was not observed to directly reduce MTT in the absence of viable cells.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based upon the results of this assay, the test substance, Di-sec-butyl peroxydicarbonate, was predi
cted to be non corrosive according to the prediction model of the OECD TG 431. Accordingly, the te
st substance, Di-sec-butyl peroxydicarbonate, would be labeled as a non corrosive material within the
Globally Harmonized System. - Executive summary:
The MatTek Corporation’s EpiDerm reconstituted human epidermis model was used to assess the
potential skin corrosivity of the test substance, Di-sec-butyl peroxydicarbonate.The skin corrosivity
potential of the testsubstancewas evaluated by measuring the relative cell viability in treated tissues after
a 3-minute and 60-minute exposure to the test substance according to theOECD Test Guideline 431
“In VitroSkin Corrosion: Human Skin Model Test” (TG 431)[1].The MTT (3-[4,5-dimethylthiazol-2-yl]-2,5-
diphenyltetrazolium bromide) conversion assay, which measures the NAD(P)H-dependent microsomal
enzyme reduction of MTT (and to a lesser extent, the succinate dehydrogenase reduction of MTT) to
a blue formazan precipitate, was used to assess cellular metabolism after test substance exposure[2].
Under the conditions specified inthis study, the testsubstance,Di-sec-butyl peroxydicarbonate, resulted
in a cell viability of 83% and 16.9% after the 3 minute and the 60 minute exposures, respectively;
thus, the test substance was predicted to be corrosive. Accordingly, the test substance,Di-sec-butyl
peroxydicarbonate, would not require classification and labelling for skin corrosivity[KJ(1] .Results of
the positive control and negative control met the criteria of a valid assay.
[1] OECD Test Guideline 431 “In Vitro Skin Corrosion: reconstructed human epidermis (RHE)
test method”, Adopted 29 July 2016.
[2] Berridge, M.V., Tan, A.S., McCoy, K.D., Wang, R. (1996) The Biochemical and Cellular Basis
of Cell Proliferation Assays That Use Tetrazolium Salts.Biochemica4:14-19.
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