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EC number: 201-128-1 | CAS number: 78-63-7
- 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 vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to established principles and published methods which were current at the time but not OECD guideline. There is no CoA for the test material; it is described only by trade name, lot number and physical appearance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- see below
- Principles of method if other than guideline:
- - Exposure period was 24 hours under occlusion, not 4 hours under semi-occlusion.
- The protocol states that animals may be used for 1 - 4 test substances, although it cannot be determined whether or not that occurred in this study.
- The observation period was 72 hours not 14 days. - GLP compliance:
- no
Test material
- Reference substance name:
- Di-tert-butyl 1,1,4,4-tetramethyltetramethylene diperoxide
- EC Number:
- 201-128-1
- EC Name:
- Di-tert-butyl 1,1,4,4-tetramethyltetramethylene diperoxide
- Cas Number:
- 78-63-7
- Molecular formula:
- C16H34O4
- IUPAC Name:
- 2,5-bis(tert-butylperoxy)-2,5-dimethylhexane
- Details on test material:
- The test material was a clear colourless liquid, batch no. 220981.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Twelve health adult New Zealand White albino rabbits are used for 1-4 substances.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: one part shaved only, one part shaved and abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours following patch removal
- Number of animals:
- Twelve (six intact, six abraded)
- Details on study design:
- Twenty four hours prior to applying the materials, the hair is removed from the backs of the animals with an electric clipper in such a way as to avoid abrasions. 0.5 ml of the test substance is brought on the intact or abraded skin under a surgical patch measuring 1 inch x 1 inch. The patches are fixed to the application site by means of adhesive tape and the entire trunk of the rabbits is wrapped with an impervious material to maintain the test patches in position and to retard evaporation of volatile substances.
Six rabbits are treated on the intact skin, the other six on the abraded skin. The abrasions are minor incisions through the stratum corneum, but not sufficiently deep to disturb the derma or to produce bleeding.
After an exposure period of 24 hours the patches and the material applied are removed and the resulting skin reactions are evaluated by the method of Draize. A second reading is made 48 hours later (72 hours after application).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: an additional 48 hours
- Remarks on result:
- other: intact skin; all scores 4 out of 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- other: last observation for this study
- Remarks on result:
- other: intact skin; all scores 4 out of 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: an additional 48 hours
- Remarks on result:
- other: intact skin; all scores 2 out of 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- other: last observation for this study
- Remarks on result:
- other: intact skin; all scores 1 out of 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 3.6
- Max. score:
- 4
- Reversibility:
- not fully reversible within: an additional 48 hours
- Remarks on result:
- other: abraded skin; for erythema five animals had score 4 out of 4, one animals had score 2 out of 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 3.5
- Max. score:
- 4
- Reversibility:
- other: last observation for this study
- Remarks on result:
- other: abraded skin; five animals had score 4 out of 4, one animal had score 1 out of 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- not fully reversible within: an additional 48 hours
- Remarks on result:
- other: abraded skin; two animals had score 2 out of 4, four animals had score 1 out of 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- other: last observation for this study
- Remarks on result:
- other: abraded skin; four animals had score 1 out of 4, two animals had score 0 out of 4
- Irritant / corrosive response data:
- On the basis of the present results it can be concluded that the substance is a severe primary skin irritant.
- Other effects:
- None reported.
Any other information on results incl. tables
Its dermal effects observed after 24 hours generaly consisted of well-defined erythema, slight to distinct ischemia and very slight to slight edema. The dermal effects observed after 72 hours generally consisted of slight to distinct incrustation and very slight edema. There were no distinct differences between skin reactions of the intact skin and those of the abraded skin.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- On the basis of the present results it can be concluded that the substance is a severe primary skin irritant. Mean value of > 2.3 - < 4.0 for erythema in all animals from gradings at 24, 48 and 72 hours after patch removal. Reversibilty of these effects cannot be judged from this study since the observations stopped after 72 hours. However corrosion was not observed and the animals were exposed for 24 hours instead of 4 hours.
Based on these results, the test substance needs to be labelled for skin irritation Cat 2 according to
the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the
United Nations (2017) (including all amendments) and Regulation (EC) No 1272/2008 on
classification, labelling and packaging of items and mixtures (including all amendments). - Executive summary:
Primary irritation to the skin is measured by a patch-test technique on the abraded and intact skin of albino rabbits. It caused severe skin irritation. Its dermal effects observed after 24 hours generaly consisted of well-defined erythema, slight to distinct ischemia and very slight to slight edema. The dermal effects observed after 72 hours generally consisted of slight to distinct incrustation and very slight edema. There were no distinct differences between skin reactions of the intact skin and those of the abraded skin.
On the basis of the present resutls it can be concluded that the substance is a severe primary skin irritant.
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