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Diss Factsheets
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EC number: 945-746-6 | CAS number: -
- 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
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Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- Not reported
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- Human repeated insult patch test
- GLP compliance:
- no
Test material
- Reference substance name:
- 1,5,10-trimethylcyclododeca-1,5,9-triene, epoxidised
- EC Number:
- 945-746-6
- Molecular formula:
- Not Applicable
- IUPAC Name:
- 1,5,10-trimethylcyclododeca-1,5,9-triene, epoxidised
- Test material form:
- not specified
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 50 subjects;
- Sex: 29 males; 21 females
- Age: Males: 22-48 years (Caucasian); 28 year (negro); 23-34 years (oriental) /females: 19-52 years (Caucasian); 30 year (oriental) - Clinical history:
- None
- Controls:
- White Petrolatum
- 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: oval-shabed adhesive patches (1" x 1-1/4") with curcular gauze centers
- Vehicle / solvent: White petrolatum
- Concentrations: 2% in White Petrolatum
- Volume applied: Approximately 0.3 mL
- Testing schedule:
Phase I (Induction phase): Total of 9 induction applications
Phase III (challenge phase): 2 weeks after the last induction, on a new skin site, for 24-hr
EXAMINATIONS
Grading/Scoring system: Scoring Criteria for Skin Irritation Reactions
- Erythema and Eschar Formation:
No reaction: 0
Very slight erythema (barely perceptible): 1
Mild, well-defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4
- Oedema Formation:
No reaction: 0
Very slight oedema (barely perceptible): 1
Slight oedema (edge of area well-defined by definite raising): 2
Moderate oedema (area raised approximately 1 mm): 3
Severe oedema (area raised more than 1 mm and extending beyond area of exposure): 4
- Statistical analysis: None
Results and discussion
- Results of examinations:
- SYMPTOMS
None
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 50
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0
Applicant's summary and conclusion
- Conclusions:
- Under the condition of the study, the test material is not a skin sensitizer at 2% in White Petrolatum.
- Executive summary:
A panel of 50 male and female human volunteers participated in a repeat insult patch test in which a 2% in White Petrolatum of the test material was applied under occlusive patches. During the induction phase nine patches were applied. Two weeks after the last induction application, a challenge patch was applied and the sites scored 24 h (after removal of patch).
Under the conditions employed in this study, there was no evidence of sensitisation to the test material.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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