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EC number: 441-420-8 | CAS number: 113889-23-9
- 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
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- from 24-09-2001 to 08-02-2002
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study performed in accordance with Standard Operating Procedures of Hill Top Research, INC. No official guideline available.
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The skin sensitising properties of Cyclobutanate were investigated in a Human Repeated Insult Patch Test (HRIPT), in which human volunteers were induced during 9 treatments, followed by a challenge treatment.
- GLP compliance:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 441-420-8
- EC Name:
- -
- Cas Number:
- 113889-23-9
- Molecular formula:
- C14H20O2
- IUPAC Name:
- tricyclo[5.2.1.0²,⁶]dec-3-en-8-yl butanoate; tricyclo[5.2.1.0²,⁶]dec-4-en-8-yl butanoate
- Test material form:
- liquid
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 129 (114 subjects completed the study)
- Sex: M (12) / F (102)
- No information on age and race
- Demographic information: no information available - Clinical history:
- No information available.
- Controls:
- Yes, standard control substance taken into account
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: Occlusive
- Description of patch: No information available
- Vehicle / solvent: No information
- Concentrations: 5%
- Volume applied: 0.2 mL/patch
- Testing/scoring schedule: 9 induction treatments followed by a challenge which was read at 24, 48 and 72h
- Removal of test substance: no information available
- Other: test site: paraspinal region of the back
EXAMINATIONS
- Grading/Scoring system:
0 No visible reaction
1 Mild reaction
2 Moderate reaction
3 Severe reaction
Results and discussion
- Results of examinations:
- SYMPTOMS
- Frequency, level, duration of symptoms observed:
Reactions to Cyclobutanate: isolated instance of mild erythema, at the challenge 2 instances of mild and one of moderate erythema were observed at the 24-hour evaluation, and were all resolved by the 48-hour evaluation.
Reactions to test substance B (control): mild erythema for subject No. 38 after application 2 which was resolved by application 6. At the challenge a single instance of mild erythema was observed at the 24-hour evaluation which was resolved by the 48-hour evaluation.
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 2
- Number of subjects with negative reactions: 112
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0
RESULT OF CASE REPORT: For the 2 subjects who exhibited a positive challenge, No. 28 and 49, a rechallenge was performed under the same testing conditions as specified in the original protocol. There was no sensitization indicated at rechallenge at the 24-, 48-, and 72-hour evaluations.
Applicant's summary and conclusion
- Conclusions:
- In a Human Repeated Insult Patch Test performed with human volunteers, a positive skin reaction at challenge was seen in 2 out of 114 test subjects. These subjects were rechallenged and no skin sensitization was indicated at 24, 48 and 72 hours after rechallenge application.
- Executive summary:
The sensitising potential of Cyclobutanate was determined in a Human Repeated Insult Patch Test (HRIPT), which was performed according to Standard Operating Procedures of the research lab (no guideline available). Topical application was performed with 5% Cyclobutanate and a control substance.
Reactions to Cyclobutanate: isolated instance of mild erythema, at the challenge 2 instances of mild and one of moderate erythema were observed at the 24-hour evaluation, and were all resolved by the 48-hour evaluation. Reactions to the control substance: mild erythema for subject No. 38 after application 2 which was resolved by application 6. At the challenge a single instance of mild erythema was observed at the 24-hour evaluation which was resolved by the 48-hour evaluation.
Under the conditions of this study, a positive skin reaction at challenge was seen in 2 out of 114 test subjects. These subjects were rechallenged and no sensitization was indicated at 24, 48 and 72 hours after rechallenge application.
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