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EC number: 429-960-2 | CAS number: 27610-48-6
- 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:
- 08.04.1986 to 21.04.1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline Study performed under GLP.
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:
- EPA OTS 798.4470 (Acute Dermal Irritation)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 429-960-2
- EC Name:
- -
- Cas Number:
- 27610-48-6
- Molecular formula:
- C16H16O4
- IUPAC Name:
- 2-[({6-[(oxiran-2-yl)methoxy]naphthalen-1-yl}oxy)methyl]oxirane
- Test material form:
- liquid: viscous
- Details on test material:
- -Appearance: Brown viscous liquid.
The sample was received on 15 January 1986 and was stored at ambient temperature.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- -New Zealand White strain rabbits in the weight range 2.3 to 2.8 kg, prior to treatement on Day 1 and approximately 10 to 12 weeks of age were obtained fromFroxfield rabbits, Petersfield, Hamshire, England.
-The rabbits selected for the study were all acclimated to the laboratory environment.
-Each animal was identified by a numbered aluminium tag placed through the edge of one ear. This number was unique within the HRC Industrial Toxicology Departmentthroughout the duration of the study.
-The rabbits were individually housed in metal cages with perforated floors in Building R14 Room1. They had free access to tap water and SDS Standard Rabbit Diet.
-Animal room temperature was maintained at approximately 19°C and relative humidity at 30-70%.
-Air exchange was maintained at approximately 19 air changes per hour and lighting was controlled by means of a time switch to give 12 hours of artificial light (0700-1900) hours in each 24 hour period.
-All animals were observed daily for signs of ill health or toxic signs.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated flank
- Amount / concentration applied:
- no data
- Duration of treatment / exposure:
- Exposure duration: 4 hours
- Observation period:
- -Examination of the treated skin was made on Day 1 (i.e. approximately 30 minutes after removal of the patches) and on Day 2, 3 and 4. Additional observations were made on Days 5 through 14.
- Number of animals:
- -Six New Zealand White strain males rabbits.
- Details on study design:
- TEST SITE
- Area of exposure: The dorso-lumbar region of each rabbit.
- % coverage: 10 cm square
- Type of wrap if used: Gauze pad and each treatment site was occluded with "Elastoplast" elastic adhesive.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Done using distilled water in an attempt to remove any residual test substance.
- Time after start of exposure: after 4 hours period.
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 slight eschar formation (injuries in depth: 4
Oedema formation:
-No oedema: 0
-Very slight oedema (barely perceptible): 1
-Slight oedema (edges of aera well-defined by definite raising): 2
-Moderate oedema (raised approximately 1 millimetre): 3
-Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure): 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: day 1 to 14
- Score:
- >= 1 - <= 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: day 1 to 14
- Score:
- >= 1 - <= 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: day 1 to 14
- Score:
- >= 1 - <= 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 12 days
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: day 1 to 14
- Score:
- >= 1 - <= 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: day 1 to 14
- Score:
- >= 2 - <= 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- other: day 1 to 14
- Score:
- >= 1 - <= 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: day 1 to 14
- Score:
- >= 1 - <= 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: day 1 to 14
- Score:
- >= 1 - <= 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: day 1 to 14
- Score:
- >= 1 - <= 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- other: day 4 to 14
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- other: day 1 to 14
- Score:
- >= 1 - <= 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 12 days
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- other: day 1 to 14
- Score:
- >= 1 - <= 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritant / corrosive response data:
- There was no initial response to the four hours exposure to Epiclon EXA 4032, however, by Day 2 slight to well-defined reactions had developed. These increased in severity and by Day 4 necrotic lesions were observed in 2 rabbits and well-defined erythema with very slight to slight oedema in the four remaining animals. Ar this time whiote "blanched" arears also saterted to develop and by Day 7 were present in four rabbits.
Slight to well-defined or moderate reactions accompanied by desquamation of the stratum corneum were still present on Day 14.
Considerable difficulty had been experienced in trying to remove the test substance at the end.
Applicant's summary and conclusion
- Conclusions:
- In conclusion, a single semi-occlusive application of EPICLON EXA 4032 to intact rabbit skin for four hours elicited well-defined to severe dermal irritation.
- Executive summary:
This study was designed to assess skin irritation potential in the rabbit.The study was performed according Guidelines as described in the Federal Register, Vol. 50, N° 188, Part II of 27 September 1985, Section 798.4470_Primary Dermal Irritation.
For the experiment, six New Zealand White starin rabbits were used.
A 0.5 ml aliquot of EPICLON EXA 4032 was applied under a 2.5 cm square gauze pad to one intact skin site on each animal during four hours (semi-occlusive application).
Examination of the treated skin was made on Day 1 (i.e. approximately 30 minutes after removal of the patches) and on Day 2, 3 and 4. Additional observations were made on Days 5 through 14.
In conclusion, a single semi-occlusive application of EPICLON EXA 4032 to intact rabbit skin for four hours elicited well-defined to severe dermal irritation.
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