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Diss Factsheets
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EC number: 943-328-8 | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- From April 1 to May 5, 1981
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- Modification of the usual Draize Repeated Insult Patch Test as described in "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics"
- GLP compliance:
- no
Test material
- Reference substance name:
- Reaction Mass of 4-(2,6,6-trimethylcyclohex-1-en-1-yl)butan-2-one and 4-(2,6,6-trimethylcyclohex-2-en-1-yl)butan-2-one and 4-[(1RS,6RS)-2,2,6-trimethylcyclohexyl]butan-2-one and (2RS,4aRS)-2,5,5-trimethyl-1,2,3,4,4a,5,6,7-octahydronaphthalen-2-ol and 2,5,5-trimethyl-1,2,3,4,5,6,7,8-octahydronaphthalen-2-ol
- EC Number:
- 943-328-8
- Molecular formula:
- Not applicable
- IUPAC Name:
- Reaction Mass of 4-(2,6,6-trimethylcyclohex-1-en-1-yl)butan-2-one and 4-(2,6,6-trimethylcyclohex-2-en-1-yl)butan-2-one and 4-[(1RS,6RS)-2,2,6-trimethylcyclohexyl]butan-2-one and (2RS,4aRS)-2,5,5-trimethyl-1,2,3,4,4a,5,6,7-octahydronaphthalen-2-ol and 2,5,5-trimethyl-1,2,3,4,5,6,7,8-octahydronaphthalen-2-ol
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): MT-112 (4 %)
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 50 for RIPT, including 20 also tested for photosensitization
- Sex: 9 males and 41 females (including 4 males and 16 females also tested for photosensitization)
- Age: 16 to 71 years - Clinical history:
- Not specified
- Controls:
- None
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: Patch test (epicutaneous test)
ADMINISTRATION - RIPT
- Type of application: Semiocclusive
- Application site: Upper arms for induction; same site + untreated skin sites for challenge
- Description of patch: gauze and loosely applied Dermicel tape, remained in place for 24 hours.
- Vehicle / solvent: None
- Concentrations: Undiluted
- Volume applied: 0.2 g
- Testing schedule: 3 times a week for 3 weeks for a total of 9 applications. Challenge application was done after a two-week rest period.
- Scoring schedule: 24 h after induction patch removal; 24, 48 and 72 h after challenge patch removal
- Removal of test substance: Excess material was wiped off after 24 hours
ADMINISTRATION - Photosensitization study
- Application site: Opposite arm
- Vehicle / solvent: None
- Concentration: Undiluted
- Volume applied: 0.2 g
- Irradiation: Spectroline Model B-100, Black Light flood lamp (365 nm, 1680 microwatts/cm²). 15 minute exposure. Exposure distance: 15 inches from the lamp. Irradiation at applications 1, 4, 7 and 9 and at the challenge application.
- Type of application: After the irradiation, test site were covered with a semi-occlusive covering of gauze and loosely applied Dermicel tape.
- Testing schedule: 3 times a week for 3 weeks for a total of 9 applications. Challenge application was done after a two-week rest period.
- Scoring schedule: 24 h after induction patch removal; 24, 48 and 72 h after challenge patch removal
- Removal of test substance: Excess material was wiped off after 24 hours
EXAMINATIONS
- Grading/Scoring system: No data
- Statistical analysis: None
Results and discussion
- Results of examinations:
- 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
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Conclusions:
- The test material (4 %) does not appear to be a primary skin irritant or fatiguing agent. No sensitization reactions were noted. Exposure to UV-A light does not appear to initiate or increase the incidence and severity of irritation, fatigue or sensitization.
- Executive summary:
A panel of 50 male and female human volunteers participated in a repeat insult patch test in which the test material (4 %) was applied to the upper arms of the subjects under semi-occlusive patches. During the induction phase nine patches were applied, separated by a 48-hour interval. The patches were removed 24 hours after application. Following a 14-day rest period, a challenge patch was applied and the sites scored 24, 48 and 72 hours after application. A subset of 20 subjects selected from the group of 50 subjects was simultaneously studied for photosensitization. 15 minute irradiation period were applied at application 1, 4, 7, 9 and at challenge application on the opposite arms.
The test material does not appear to be a primary skin irritant or fatiguing agent. No sensitization reactions were noted. Exposure to UV-A light does not appear to initiate or increase the incidence and severity of irritation, fatigue or sensitization.
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