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Diss Factsheets
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EC number: 916-737-4 | 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
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- May 01, 1996 - June 17, 1996
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Not a validated method for determining skin irritation or skin sensitisation, but provides reliable supporting information for “in-use” concentrations using a “standard practice” applied to ingredients for consumer formulations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Repeated Insult patch test: A 9-day repeated occlusive application for 24 hours, after which a rest period of approximately 2 weeks, a challenge patch was applied to fresh sites and were scored 24 and 72-hours after application.
- GLP compliance:
- no
- Remarks:
- but conducted in accordance with Good Clinical Practice
Test material
- Reference substance name:
- Reaction mass of 2-[7-isopropyl-5-methylbicyclo[2.2.2]oct-5-en-2-yl]-1,3-dioxolane and 2-[8-isopropyl-6-methylbicyclo[2.2.2]oct-5-en-2-yl]-1,3-dioxolane
- EC Number:
- 916-737-4
- Molecular formula:
- Reaction mass of 2-[7-isopropyl-5-methylbicyclo[2.2.2]oct-5-en-2-yl]-1,3-dioxolane and 2-[8-isopropyl-6-methylbicyclo[2.2.2]oct-5-en-2-yl]-1,3-dioxolane
- IUPAC Name:
- Reaction mass of 2-[7-isopropyl-5-methylbicyclo[2.2.2]oct-5-en-2-yl]-1,3-dioxolane and 2-[8-isopropyl-6-methylbicyclo[2.2.2]oct-5-en-2-yl]-1,3-dioxolane
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): 5% Sample D in DMP
- Description: Transparent liquid
- Received on April 24, 1996
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- other: informed consent was obtained
- Subjects:
- - Number of subjects exposed: 55 (53 completed the study)
- Sex: 2 males and 53 females
- Age: 20 to 63 years
- Other: the subjects did not exhibit any physical or dermatological condition that would have precluded application of the test substance. - Clinical history:
- No data.
- Controls:
- No.
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: repeated insult patch test
ADMINISTRATION
- Type of application: occlusive
- Induction phase:
Approximately 0.2 mL test substance was placed onto a Parke-Davis Readi-Bandage occlusive patch, which was applied to the back of each subject between the scapulae and waist, adjacent to the spinal mid-line.
The subjects were instructed to remove the patch 24-hours after application. 24-hour rest periods followed the Tuesday and Thursday removals and 48-hour rest periods followed each Saturday removal. The site was scored by a trained examiner just prior to the next patch application. This procedure was repeated every Monday, Wednesday and Friday until 9 applications of the test substance had been made.
- Challenge phase:
After a rest period of approximately 2 weeks, the challenge patch was applied to a previously unpatched (virgin) test site. The site was scored 24 and 72-hours after application.
EXAMINATIONS
Skin responses for both the induction and challenge phases of the study were scored according to the following 6-point scale:
0 = No evidence of any effect
+ = Barely-Perceptible (minimal, faint, uniform or spotty erythema)
1 = Mild (pink, uniform erythema covering most of the contact site)
2 = Moderate (pink-red erythema uniform in the entire contact site)
3 = Marked (bright-red erythema with/wthout petechiae or papules)
4 = Severe (deep-red erythema with/without vesiculation or weeping)
All other observed dermal sequelae are appropriately recorded and described as mild, moderate or severe.
Results and discussion
- Results of examinations:
- No skin responses were observed during the induction phase.
A transient, barely-preceptible non-specific patch test response was observed on one test panelist during the challenge phase of the study. This non-specific response was not considered to be irritant or allergic in nature.
Two subjects discontinued for personal reasons.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of a repeated insult (occlusive) patch test procedure, the test substance 5% Sample D in DMP did not induce irritation nor show any evidence of induced allergic contact dermatitis in human subjects.
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