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EC number: 236-502-3 | CAS number: 13410-58-7
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02 August 2004 to 23 September 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF Testing Guideline of 12 Nousan No. 8147
- Version / remarks:
- 2000
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2,2'-[(1-methylethylidene)bis(cyclohexane-4,1-diyloxymethylene)]bisoxirane
- EC Number:
- 236-502-3
- EC Name:
- 2,2'-[(1-methylethylidene)bis(cyclohexane-4,1-diyloxymethylene)]bisoxirane
- Cas Number:
- 13410-58-7
- Molecular formula:
- C21H36O4
- IUPAC Name:
- 2-({[4-(2-{4-[(oxiran-2-yl)methoxy]cyclohexyl}propan-2-yl)cyclohexyl]oxy}methyl)oxirane
- Test material form:
- liquid: viscous
- Details on test material:
- - Appearance: Liquid, viscous / colourless
- Storage: Room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 4 - 5 months
- Weight at study initiation: 3.10 - 3.13 kg
- Housing: individually housed in stainless steel wire mesh cages with grating, floor area: 3000 cm²
- Diet: about 130 g/animal per day
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24°C
- Humidity: 30 - 70%
- Photoperiod: 12 h light (6.00 a.m. - 6.00 p.m.) 12 h darkness (6.00 p.m. - 6.00 a.m.)
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 animals (one female, two males)
- Details on study design:
- REMOVAL OF TEST MATERIAL
- About 24 hours after application of the liquid test material the treated eye of the animal(s) was rinsed with 3 to 6 mL of hand warm tap water for 1 to 2 minutes using a syringe with a blunt probe.
SCORING SYSTEM:
- Readings were made at approx. 1, 24, 48 and 72 h after application.
- Assessment of ocular reactions:
Cornea opacity (op):
Degree of density (the most dense area is taken for reading)
0 = No ulceration or opacity
1 = Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible
2 = Easily discernible translucent area, details of iris slightly obscured
3 = Nacreous area, no details of iris visible, size of pupil barely discernible
4 = Opaque cornea, iris not discernible through the opacity
Area of cornea involved (ar):
1 = > 0 ≤ ¼
2 = > ¼ < ½
3 = > ½ < ¾
4 = > ¾
Iris:
0 = Normal
1 = Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection, any of these observations or combination of any thereof, iris still reacting to light (sluggish reaction is positive)
2 = No reaction to light, haemorrhage, gross destruction (any or all of these)
Conjunctivae redness (red):
(Refers to palpebral and bulbar conjunctivae, not to cornea and iris)
0 = Blood vessels normal
1 = Some blood vessels definitely hyperaemic (injected)
2 = Diffuse, crimson colour, individual vessels not easily discernible
3 = Diffuse beefy red
Chemosis (sw):
Lids and/or nictitating membrane
0 = No swelling
1 = Any swelling above normal (includes nictitating membranes)
2 = Obvious swelling with partial eversion of lids
3 = Swelling with lids about half closed
4 = Swelling with lids more than half closed
Discharge (di):
0 = No discharge
1 = Any amount different from normal (does not include small amounts observed in inner canthus of normal animals)
2 = Discharge with moistening of the lids and hairs just adjacent to lids
3 = Discharge with moistening of the lids and hairs, and considerable area around the eye
EVALUATION OF RESULTS
- For evaluation, the calculation of the mean values of corneal opacity, iris, conjunctival redness and chemosis for readings 24, 48 and 72 hours were quoted. Additionally, the reversibility of the observed findings was taken into account.
TOOL USED TO ASSESS SCORE: Daylight tubes "Lumilux" were used for illumination when reading the eye.
OTHER OBSERVATIONS
- Animals were checked for dead/moribund animals twice each workday (beginning and end) and once animals: on Saturdays, Sundays and on public holidays.
- Body weights were recorded just before application of the test material and after the last reading.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- - Moderate conjunctival redness (grade 2) was observed in all animals after 1 hour and decreased to slight conjunctival redness (grade 1) in one animal after 24 hours. Slight conjunctival chemosis (grade 1) was noted in two animals and slight discharge (grade 1) was observed in all animals one hour after application only.
- In addition, injected scleral vessels in a circumscribed area or circular were observed in all animals at the 1-hour reading.
- The ocular reactions were reversible in two animals within 24 hours and in one animal within 48 hours after application.
- Mean scores calculated for each animal over 24, 48 and 72 hours were 0 .0 for corneal opacity and for iris lesions, 0.0, 0.3 and 0.0 for redness of the conjunctiva and 0.0 for chemosis.
Any other information on results incl. tables
Table 1: Individual ocular examinations and mean values
Readings |
Animal |
Cornea |
Iris |
Conjunctiva |
Additional findings |
|||
Opacity |
Area of cornea involved |
Redness |
Chemosis |
Discharge |
||||
1 h |
1 |
0 |
0 |
0 |
2 |
0 |
1 |
* |
2 |
0 |
0 |
0 |
2 |
1 |
1 |
# |
|
3 |
0 |
0 |
0 |
2 |
1 |
1 |
# |
|
24 h |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 |
0 |
0 |
0 |
1 |
0 |
0 |
|
|
3 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
48 h |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
3 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
72 h |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
3 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
Mean 24-72 h |
1 |
0.0 |
- |
0.0 |
0.0 |
0.0 |
- |
|
2 |
0.0 |
- |
0.0 |
0.3 |
0.0 |
- |
|
|
3 |
0.0 |
- |
0.0 |
0.0 |
0.0 |
- |
|
|
Mean |
- |
0.0 |
- |
0.0 |
0.1 |
0.0 |
- |
|
* scleral vessels injected, circumscribed area
# scleral vessels injected, circular
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified in accordance with EU Criteria
- Conclusions:
- Under the conditions of this study, the test material is not irritating to the eye.
- Executive summary:
The potential of the test material to cause irritation to the eye was investigated in accordance with the standardised guidelines OECD 405, EU Method B5, OPPTS 870.2400 and JMAFF, under GLP conditions.
During the study, 0.1 mL of test material was applied to one eye of three White New Zealand rabbits (stepwise procedure starting with one animal and supplementing two additional animals). About 24 hours after application the eye was rinsed with tap water. The ocular reactions were assessed approximately 1, 24, 48 and 72 hours after application.
Slight or moderate conjunctival redness, slight conjunctival chemosis and slight discharge were observed in the animals up to 24 hours after application at latest. In addition, injected scleral vessels in a circumscribed area or circular were noted in all animals 1 hour after application. The average score (24 to 72 hours) for irritation was calculated to be 0.0 for corneal opacity and iris, 0 .1 for conjunctival redness and 0.0 for chemosis.
Under the conditions of this study, the test material was concluded to be not irritating to eyes.
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