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EC number: 252-029-5 | CAS number: 34443-12-4
- 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 irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP OECD study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- OO-tert-butyl O-(2-ethylhexyl) peroxycarbonate
- EC Number:
- 252-029-5
- EC Name:
- OO-tert-butyl O-(2-ethylhexyl) peroxycarbonate
- Cas Number:
- 34443-12-4
- Molecular formula:
- C13H26O4
- IUPAC Name:
- 3-({[(tert-butylperoxy)carbonyl]oxy}methyl)heptane
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Animals were received from Ace Animals, Boyertown, PA on 5/18/99
The pretest body weight range was 2.3-2.7 kg.
The animals were born the weeks of 2/28 through 3/21/99
The animals were identified by cage notation and a uniquely numbered metal eartag and housed 1/cage in suspended wire cages.
Bedding was placed beneath the cages and changed at !east three times/week
Fresh Purina Rabbit Chow (Diet #5321) was provided daily. Water was freely available. The animal room, reserved exclusively for rabbits on acute tests, was temperature controlled (68 - 72°F) with a humidity range of 57- 72%, had a 12 hour light/dark cycle, and was kept clean and vermin free.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL (undiluted) - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Until 7 days after removal of the patch
- Number of animals:
- 3
- Details on study design:
- The test article was placed under a 2.5 x 2.5 cm, 4 ply, surgical gauze patch
The patch was secured with non-irritating tape. The torso was wrapped with plastic in a semi-occlusive manner and secured with non-irritating tape which completely covered the plastic. Residual test article was removed from the test site by gentle washing with distilled water at the end of the exposure period, prior to scoring fur dermal reactions.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
Any other information on results incl. tables
Body Weight observations:
R.abbitEartag: |
F2084 |
F2103 |
F2106 |
Sex: Pre test Body Weight-kg |
F 2.7 |
F 2.3 |
F -2.6 |
72 Hour Body Weight-kg |
2.7 |
2.4 |
2.5 |
Tenninal Body Weight-kg |
2.8 |
2.8 |
2.7 |
Erythema and escar scores:
R.abbitEartag: |
F2084 |
F2103 |
F2106 |
60 minutes |
2 |
2 |
1 |
24 hours |
2 |
2 |
1 |
48 hours |
1 |
2 |
0 |
72 hours |
0 |
2 |
0f |
7 days |
0 |
2 |
0f |
f: flaking skin
Edema scores:
R.abbitEartag: |
F2084 |
F2103 |
F2106 |
60 minutes |
1 |
1 |
0 |
24 hours |
1 |
2 |
0 |
48 hours |
0 |
1 |
0 |
72 hours |
0 |
1 |
0 |
7 days |
0 |
1 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance TBEC elicited slight skin irritation in an OECD 404 test, but doesn't need to be classified as irritating to skin, according to EU regulation, since mean scores for erythema, eschar formation, and oedema, are less than 2 (only one animal with a mean score of 2 for erythema and eschar formation).
- Executive summary:
The acute dermal irritation potential of TBEC was evaluated in rabbits according to OECD 404 guideline . The substance was applied undiluted to the skin of 3 New-Zealand White albino rabbits and held in contact for 4 hours by means of a semi-occlusive dressing.
Oedemal reactions were scored at 60 minutes after removal of wrappings. Reactions were scored again at 24, 48 and 72 hours and on day 7 following patch removal.The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction at these timeperiods. Bodyweights were recorded pre-test, 72 hours and at termination.
Mean scores for erythema, eschar formation, and oedema, were less than 2 (excepting for one animal: a mean score of 2 for erythema and eschar formation was recorded).Erythema was barely perceptible to slight at 60 minutes and 24 hours following patch removal and absent to slight at 48 and 72 hours and on day 7. Edema was absent to barely perceptible at 60 minutes following patch removal, absent to slight at 24 hours and absent to barely perceptible at 48 and 72 hours and on day 7.
There were no abnormal physical signs noted during the observation period.
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