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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 July 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 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 7 - 8 months
- Weight at study initiation: 3.67 - 3.91 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
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL undiluted test material applied to a 2.5 x 2.5 cm patch
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 3 animals (2 males and 1 female)
- Details on study design:
- TEST SITE
- Area of exposure: Flank, dorsolateral part of the trunk
- % coverage: a 2.5 x 2.5 cm patch moistened with the test material was applied to the untreated clipped skin.
- Type of wrap if used: semiocclusive dressing (patch and fleece)
REMOVAL OF TEST SUBSTANCE
- The test material was removed at the end of the exposure period (4 hours) with polyethylenglycol and polyethylenglycol/water (1:1).
OBSERVATION TIME POINTS
- Immediately after removal of the patch, approx. 1, 24, 48 and 72 h after removal of the patch and then in weekly intervals maximally up to day 14.
- Body weights were determined before application of the test material and after the last reading.
- Daylight tubes "Lumilux" were used for illumination for assessing the treatment sites.
- Twice each workday (beginning and end) and once on Saturdays, Sundays and on public holidays the cages were checked for dead/moribund animals.
SCORING SYSTEM:
- Erythema and eschar formation:
No erythema = 0
Very slight erythema (barely perceptible = 1
Well defined erythema = 2
Moderate to severe erythema = 3
Severe erythema (beet redness) to eschar formation preventing grading of erythema = 4
- Oedema formation:
No oedema = 0
Very slight oedema (barely perceptible) = 1
Slight oedema (edges of area well defined by definite raising) = 2
Moderate oedema (raised approx. 1 mm) = 3
Severe oedema (raised more than 1 mm and extending beyond area of exposure) = 4
Description of any dermal findings not covered by this scale were also recorded.
EVALUATION OF RESULTS
- For evaluation, the calculation of the mean values of erythema and oedema for readings at 24, 48 and 72 hours were quoted. Additionally, the reversibility of the observed findings was taken into account.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- - Moderate erythema (grade 2) was observed in all animals immediately after removal of the patch and after 1 hour. Slight erythema (grade 1) was noted in two animals after 24 hours and persisted in one animal up to 72 hours after removal of the patch.
- In one animal erythema was extended beyond the area of exposure up to 1 hour after removal of the patch.
- The cutaneous reactions were reversible within 24 hours, 48 hours or 7 days after removal of the patch in one animal each.
- Mean scores over 24, 48 and 72 hours for each animal were 0.3, 0.0 and 1.0 for erythema and 0.0 for oedema.
Any other information on results incl. tables
Table 1: Irritant response data
Readings |
Animal |
Erythema |
Oedema |
Additional findings |
0 h |
1 |
2 |
0 |
|
2 |
2 |
0 |
|
|
3 |
2 |
0 |
Erythema extending beyond the area of exposure |
|
1 h |
1 |
2 |
0 |
|
2 |
2 |
0 |
|
|
3 |
2 |
0 |
Erythema extending beyond the area of exposure |
|
24 h |
1 |
1 |
0 |
|
2 |
0 |
0 |
|
|
3 |
1 |
0 |
|
|
48 h |
1 |
0 |
0 |
|
2 |
0 |
0 |
|
|
3 |
1 |
0 |
|
|
72 h |
1 |
0 |
0 |
Study discontinued because the animal was free of findings |
2 |
0 |
0 |
Study discontinued because the animal was free of findings |
|
3 |
1 |
0 |
|
|
7 days |
3 |
0 |
0 |
|
Mean 24-72 h |
1 |
0.3 |
0.0 |
|
2 |
0.0 |
0.0 |
|
|
3 |
1.0 |
0.0 |
|
|
Mean |
- |
0.4 |
0.0 |
|
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 skin.
- Executive summary:
The potential of the test material to cause irritation to the skin was determined in accordance with the standardised guidelines OECD 404, EU Method B.4, OPPTS 870.2500 and JMAFF, under GLP conditions.
During the study 0.5 mL of test material was applied for 4 hours to the intact skin of three rabbits, using a patch of 2.5 cm x 2.5 cm, covered with semi-occlusive dressing. After removal of the patch the application area was washed. The cutaneous reactions were assessed immediately after removal of the patch, approximately 1, 24, 48, 72 hours and 7 days after removal of the patch.
Slight or moderate erythema was observed in the animals during the course of the study. In one animal erythema was partly extended beyond the area of exposure. The cutaneous reactions were reversible in all animals within 7 days after removal of the patch at latest. The average score (24 to 72 hours) for irritation was calculated to be 0 .4 for erythema and 0.0 for oedema.
Under the conditions of this study, the test material was not considered to be irritating to the skin.
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