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EC number: 274-919-2 | CAS number: 70833-40-8
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 72 hours
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: A GLP study done according to OECD 405 test guideline, and having supporting documentation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Instead of the protocolled 120 g food per day, 100 g was fed to the animals. This is not considered to have adversely affected the outcome of the study
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- O-(2-ethylhexyl) O,O-tert-pentyl peroxycarbonate
- EC Number:
- 274-919-2
- EC Name:
- O-(2-ethylhexyl) O,O-tert-pentyl peroxycarbonate
- Cas Number:
- 70833-40-8
- Molecular formula:
- C14H28O4
- IUPAC Name:
- 2-ethylhexyl (1,1-dimethylpropylperoxy)formate
- Test material form:
- gas under pressure: refrigerated liquefied gas
- Details on test material:
- Chemical name (IUPAC) : Carbonoperoxoic acid, OO-(1,1-dimethylpropyl), O-(2-ethylhexyl)ester
Trade name/code: Tert. amylperoxy-2-ethylhexylcarbonate
- Batch no. 850213/14/18
- Purity: 93.8%; major impurities: 2-ethylhexanol, tert. amylalcohol and di tert. amyl peroxide
- Specific gravity: 925 kg/m3 (20°C)
- Solubility: 10% (W/W) in DMSO at 20'C
- Stabllity: Stable for more than a year at 4°C; recovery from saturated sol utions in DMSO at 20° 95% after 7 days
- Appearance: Colourless, clear liquid
- Storage: At 4°C in the dark
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Animal s and husbandry
Three young adult female rabbits (approximately 7 months old) of the New
Zealand White strain were obtained from The Broekman Institute, Someren,
The Netherlands. Date of arrival at the animal house: September 18, 1985.
From that date on the animals, ear-marked 243, 244 and 245, have been
individually housed in Lurane cages with perforated floors. The
quarantine period was 12 days, the acclimation period another 5 weeks.
Their body weights were measured three days before
dose administration. They were fed standard laboratory animal diet (100
9 per day), obtained from Hope Farms, Woerden (LK-01, pellet diameter 4
mm), and had free access to tap-water. The animal room temperature was
maintained at 19 - 21'C and the relative humidity at 40-75 per cent. The
artificial light sequence was 12 hours light, 12 hours dark.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- The animals were manually restrained for dose administration. Of the
test substance 0.1 ml was instilled in the conjunctival sac of the right
eye of each animal using a syringe. The lids were then held gently
together for two seconds and released. Immediately after treatment, the
animals were transferred to their cages. The left eye, remaining
untreated, served as a control. - Observation period (in vivo):
- up to 72 hours
- Number of animals or in vitro replicates:
- three
- Details on study design:
- Administration of the test substance
The animals were manually restrained for dose administration. Of the
test substance 0.1 ml was instilled in the conjunctival sac of the right
eye of each animal using a syringe. The lids were then held gently
together for two seconds and released. Immediately after treatment, the
animals were transferred to their cages. The left eye, remaining
untreated, served as a control.
Observations
Prior to dose administration, both eyes of the animals were inspected in
order to detect any eye defect. Immediately after instillation of the
test substance, the animals were observed and abnormalities were
recorded. In addition, the eyes were examined apprOXimately 1, 24, 48
and 72 hours after instillation of the test substance.
Grading of the ocular lesions
The following scoring system was used for grading of the ocular lesions:
CORNEA:
Opacity: degree of density (area most dense taken for reading)
No ulceration or opacity ....................................... 0
Scattered or diffuse areas of opacity
(other than slight dulling of normal lustre),
details of iris clearly visible ................................ 1
Easily discernible translucent areas, details
of iris sl ightly obscured ...................................... 2
Nacreous areas, no details of iris visible, size of
pupil barely discernible ....................................... 3
Opaque cornea, iris not discernible through the opacity ........ 4
IRIS:
Normal ......................................................... 0
Markedly deepened rugae, congestion, swelling,
moderate circumcorneal hyperaemia or injection, any of these
or any combination thereof, iris still reacting to light
(sluggish reaction is positive) ................................. 1
No reaction to light, haemorrhage, gross destruction
(any or all of these) ........................................... 2
CONJ UNCT I V AE:
Redness: (refers to palpebral and bulbar conjunctivae,
excluding cornea and iris).
Blood vessels normal ........................................... 0
Some blood vessels definitely hyperaemic or injected ........... 1
Diffuse, crimson colour, individual vessels not
easily discernible ............................................. 2
Di ffuse beefy red .............................................. 3
Chemosis: lids and/or nictating membranes
No swell i ng .................................................... a
Any swelling above normal (includes nictating membranes) ....... 1
Obvious swelling with partial eversion of lids ...••............ 2
Swelling with lids about half closed ........................... 3
Swelling with lids more than half closed ....................... 4
The test results were evaluated according to the EEC criteria for
classification and labelling of dangerous substances (Annex VI of the EEC
Council Directive 67/548/EEC as amended by Directive 83/467/EEC: Labelling
Guide) .
3.4.2 Fluorescein treatment
Approximately twenty-four hours after instill ation of the test substance
(immediately after scoring the corneal opacity and alterations of iris and
conjunctivae), a solution of 2% fluorescein in water (pH adjusted to 7.0)
was applied to both eyes of each animal to examine quantitatively the
potential for corneal injury. The brightly green staining area indicating
epithelial damage was estimated as a percentage of the total corneal area.
Any observed local effects other than those indicated above were recorded.
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- other: all 3 animals
- Time point:
- other: 72 hrs
- Score:
- ca. 1
- Reversibility:
- fully reversible within: 72 hrs
- Remarks on result:
- other: non-irritating to eye
- Irritant / corrosive response data:
- No effects on the cornea and the iris were observed in any
of the rabbits. Slight conjunctival redness (score 1) was seen for all
animals one hour after instillation, however, this had totally disappeared
24 nours after instillation for animal 245, 48 hours after instillation for
animal 244 and 72 hour after instillation for animal 243. Sl ight
conjunctival swelling (score 1), seen in all three animals one hour after
instillation, had totally disappeared 24 hours after instillation.
Treatment of the eyes with fl uorescein 24 hours after instillation of the
test substance did not reveal any epithelial damage. Slight lacrimation was
observed one hour after instillation for animals 243 and 244. In addition,
animal 243 repeatedly closed its eyes fully or partly during observations
one and 24 hours after instillation. According to the criteria laid down in
Annex VI of the EEC Council Directive 67/548/EEC as amended by Directive
83/467/EEC (Labelling Guide), the test substance need not be labelled as an
irritant to the eyes.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- According to the criteria laid down in Annex VI of the EEC Council Directive 67/548/EEC as amended by Directive 83/467/EEC (Labelling Guide), the test substance need not be labelled as an irritant to the eyes.
- Executive summary:
A sample of tert. amylperoxy-2-ethylhexylcarbonate was tested in the rabbit acute eye irritation/corrosion test to determine its possible irritating effects. Of the test substance 0.1 ml was instilled into one of the eyes of three adult female New Zealand White rabbits. Slight conjunctival redness was observed in all three animals one hour after instillation, which however had totally disappeared 72 hours thereafter. Slight conjunctival swelling in all three animals was only seen one hour after instillation. No effects on the cornea and the iris were observed in any of the rabbits. Concluding from the criteria laid down in Annex VI of the EEC Council Directive 67/548/EEC as amended by Directive 83/467/EEC (Labelling Guide), the test substance need not be labelled as an eye irritant.
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