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EC number: 221-518-5 | CAS number: 3130-19-6
- 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:
- 02 June 1992 to 24 August 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- other: read-across target
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- other information
- Justification for type of information:
- Read across to substance with the same functional groups.
- Reason / purpose for cross-reference:
- read-across source
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Number of animals used was in excess of guideline minimum
- Principles of method if other than guideline:
- Not relevant
- GLP compliance:
- yes
Test material
- Reference substance name:
- 7-oxabicyclo[4.1.0]hept-3-ylmethyl 7-oxabicyclo[4.1.0]heptane-3-carboxylate
- EC Number:
- 219-207-4
- EC Name:
- 7-oxabicyclo[4.1.0]hept-3-ylmethyl 7-oxabicyclo[4.1.0]heptane-3-carboxylate
- Cas Number:
- 2386-87-0
- Molecular formula:
- C14H20O4
- IUPAC Name:
- 7-oxabicyclo[4.1.0]hept-3-ylmethyl 7-oxabicyclo[4.1.0]heptane-3-carboxylate
- Test material form:
- liquid
- Details on test material:
- - Appearance: Colourless, transparent, slightly viscous liquid
- Storage condition of test material: Stored at room temperature.
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: 12 to 18 weeks of age
- Weight at study initiation: 2.9 - 3.3 kg (males) and 2.6 to 3.5 kg (females)
- Housing: Housed individually in cages with wire floors (approximately 18 x 24 x 15 in.).
- Diet: ad libitum except during the actual dosing period.
- Water: Tap water from the Municipal Authority of Westmoreland County was available ad libitum except during dosing and was supplied by an automatic watering system with demand control valves mounted on each rack.
- Acclimation period: At least 5 days prior to dosing.
ENVIRONMENTAL CONDITIONS
- Temperature: 16.1 - 21.6 °C
- Humidity: 40 - 60 %
- Photoperiod (hrs dark / hrs light): 12 hour light / dark cycle.
IN-LIFE DATES: From: 02 June 1992 To: 16 June 1992
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hour exposure period.
- Observation period:
- 14 days
(Animals were observed at 1, 24, 48 and 72 hours and 7 and 14 days) - Number of animals:
- 6 (3 males and 3 females)
- Details on study design:
- TEST SITE
- Area of exposure: Dorsal area of the trunk.
- % coverage: Not documented - test site was circa 2.5 x 2.5 cm
- Type of wrap if used: Polyethylene sheeting was placed loosely over the gauze patch on which the test material was applied.
- Following application of the test material, the animals were placed in a restraining device for the 4 hour contact period.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): As much excess test material was removed as possible
- Time after start of exposure: Following the 4 hour exposure period.
SCORING SYSTEM: Draize scoring method
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.8
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritant / corrosive response data:
- Application of 0.5 mL of the test material to covered rabbit skin for a 4-hour contact period produced minor erythema on 6 of 6 rabbits. Minor transient oedema was produced on 3 animals. There was no oedema present on any animal by 2 days. Erythema subsided on all rabbits within 14 days.
- Other effects:
- There was no irreversible tissue destruction noted.
Any other information on results incl. tables
Using the EU criteria for assessing skin irritation the mean score for 24, 48 and 72 hours for erythema was 0.833 and for oedema was 0.17. Recovery was complete within 14 days for erythema and within 2 days for oedema.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this study, the test material was not considered to be a skin irritant. As a result of this, the test material does not require classification according to Regulation EC No. 1272/2008 as the criteria were not fulfilled for erythema and oedema.
- Executive summary:
In a study conducted by Myers et al, (1992), the test material was investigated for its potential to act as a skin irritant. The study was performed in accordance with the standardised guideline OECD 404, under GLP conditions.
The dorsal area of the trunk of 6 New Zealand White rabbits (3 per sex) was shaved and 0.5mL of the test material was applied via a gauze patch. Polyethylene sheeting was wrapped around the test site to create an impermeable barrier. The contact period with the test material was 4 hours after which, as much excess test material as possible was removed.
The modified primary irritation score was 1.35. Minor erythema was observed on all 6 rabbits directly after the 4 hour contact period. Minor transient oedema was evident on 3 animals but it had subsided fully by day 2. Erythema had subsided fully within 14 days. Based on these results, the test material was not considered to be a skin irritant and as such, does not require classification according to Regulation EC no. 1272/2008 or Directive 67/548/EEC.
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