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EC number: 607-858-0 | CAS number: 260781-16-6
- 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
Epidemiological data
Administrative data
- Endpoint:
- epidemiological data
- Type of information:
- other: human data
- Adequacy of study:
- supporting study
- Study period:
- 2010-09-28 to 2010-10-01
- Reliability:
- other: not rated acc. to Klimisch
- Rationale for reliability incl. deficiencies:
- other: relevant
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
- Endpoint addressed:
- skin irritation / corrosion
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The primary skin irritation potential of the test material was investigated by conducting a 48-hour patch test.
- GLP compliance:
- no
Test material
- Reference substance name:
- 1-[({[(1R,2S,5R)-5-methyl-2-(propan-2-yl)cyclohexyl]oxy}carbonyl)oxy]propan-2-ol
- EC Number:
- 607-858-0
- Cas Number:
- 260781-16-6
- Molecular formula:
- C14H26O4
- IUPAC Name:
- 1-[({[(1R,2S,5R)-5-methyl-2-(propan-2-yl)cyclohexyl]oxy}carbonyl)oxy]propan-2-ol
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- confirmed and informed consent free of coercion received
- Details on study design:
- HYPOTHESIS TESTED: To determine by epidermal contact the primary irritation potential of the test material
STUDY PERIOD: 2010-09-28 to 2010-10-01
STUDY POPULATION
- Selection criteria:
Inclusion criteria
a) Male and female subjects, age 16 (with parental or guardian consent) and over
b) Absence of any visible skin disease which might be confused with a skin reaction from the test material.
c) Prohibition of use of topical or systemic steroids and /or antihistamines for at least seven days prior to study initiation.
d) Completion of a Medical History form and the understanding and signing of an Informed Consent form.
e) Considered reliable and capable of following directions.
Exclusion criteria:
a) Ill health
b) Under a doctor's care or taking medication(s) which could influence the outcome of the study.
c) Females who are pregnant or nursing.
d) A history of adverse reactions to cosmetics or other personal care products.
- Total number of subjects participating in study: 53 subjects
- Sex/age: 37 females and 16 males; ranging in age from 16 to 74
- Total number of subjects at end of study: 51 subjects completed this study (subjects (1 male / 1 female) discontinued their participation for various reasons unrelated to the use of the test material) - Exposure assessment:
- estimated
- Details on exposure:
- METHODOLGY.
The upper back between the scapulae served as the treatment area. Approximately 0.2 mL of the test material (1 % in DEP/EtOH 3:1), or an amount sufficient to cover the contact surface was applied to the 3/4" x 3.4" absorbent pad portion of a clear adhesive dressing. When secured to the appropriate treatment site, this dressing formed an occlusive patch.
The test material remained in contact with the skin for a total of forty-eight hours. This site was then evaluated for gross changes. Absence of any visible skin change was assigned a zero value. The test site was reevaluated at seventy-two hours.
EXAMINATIONS
- Grading/Scoring system (Erythema and additional Dermal Sequelae):
0 = No visible skin reaction
0.5 = Barely perceptible
1 = Mild
2 = Moderate
3 = Marked
4 = Severe
E = Oedema
D = Dryness
S = Staining
P = Papules
V = Vesicles
B = Bullae
U = Ulceration
Sp = Spreading
Erythema was scored numerically according to this key. if present, additional Dermal Sequelae were indicated by the appropriate letter code and a numerical value for severity. - Statistical methods:
- No data
Results and discussion
- Results:
- Observations remained negative throughout the test interval.
- Confounding factors:
- No data
- Strengths and weaknesses:
- No data
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, the test material (1 % in DEP/EtOH 3:1) did not indicate a potential for dermal irritation.
- Executive summary:
In this study the potential of the test material to induce primary irritation by epidermal contact was determined. Fifty-three subjects (16 males / 37 females) ranging in age from 16 to74 years were selected for this evaluation. Fifty-one subjects completed the study. The remaining subjects (1 male / 1 female) discontinued their participation for various reasons unrelated to the use if the test material.
The test item (1 % in DEP/EtOH 3:1) was evaluated by administration to the skin of the upper back between the scapulae. Approximately 0.2 mL of the test material, or an amount sufficient to cover the contact surface was applied to an absorbent pad portion of an adhesive dressing. When secured to the appropriate treatment site, this dressing formed an occlusive patch.
The test material remained in contact with the skin for a total of forty-eight hours. This site was then evaluated for gross changes. An evaluation key was used to evaluate the treatment site. The test site was reevaluated at seventy-two hours.
The results showed that the observations remained negative throughout the test interval.
In conclusion, under the conditions of this study, the test material (1 % in DEP/EtOH 3:1) did not indicate a potential for dermal irritation.
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