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EC number: 425-340-0 | CAS number: 1337538-18-7
- 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:
- September 19 - November 04, 2005
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was conducted with adherence to the applicable ICH Guideline E6 for Good Clinical Practice and requirements provided for in 21 CFR parts 50 and 56 and in accordance to SOPs and applicable protocols and monitored by QAU. Limited information about substance identity: no purity.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: to the applicable ICH Guideline E6 for Good Clinical Practice and requirements provided for in 21 CFR parts 50 and 56 and in accordance to SOPs and applicable protocols
- Deviations:
- not specified
- GLP compliance:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 425-340-0
- EC Name:
- -
- Cas Number:
- 1337538-18-7
- IUPAC Name:
- 1-ethoxy-1,1,2,2,3,3,4,4,4-nonafluorobutane; 1-ethoxy-1,1,2,3,3,3-hexafluoro-2-(trifluoromethyl)propane
- Details on test material:
- - Name of test material (as cited in study report): MTDID 3520 = 3M (TM) Cosmetic Fluid CF-76
Constituent 1
Method
- Type of population:
- other: Male and female volunteers
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 210 subjects completed the study
- Sex: male and female
- Age: 16 to 79 years
- Race: No data
- Demographic information: no data available - Clinical history:
- Inclusion criteria:
- Male and female subjects, age 16 and over.
- Absence of any visible skin disease which might be confused with a skin reaction from the test material.
- Prohibition of use of topical or systemic steroids and/or antihistamines for at least seven days prior to study initiation.
- Completion of a Medical history form and the understanding and signing of an informed consent form.
- Considered reliable and capable of following directions.
Exclusion criteria:
- Ill health.
- Under a doctor's care or taking medication(s) which could influence the outcome of the study.
- Females who are pregnant or nursing.
- A history of adverse reactions to cosmetics or other personal care products. - Controls:
- No data available.
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test
ADMINISTRATION
- Type of application: occlusive
- Description of patch: 3/4 x 3/4 absorbent pad portion of an adhesive dressing
- Vehicle / solvent: not applicable.
- Concentrations: 100%
- Volume applied: 0.2 mL
- Testing/scoring schedule:
Induction phase:
Patches were applied for 24 hours, three times per week (e.g. monday, wednesday and friday) for a total of nine applications. The upper back between the scapulae served as the treatment area.
With the exception of the first induction patch reading, if any test site exhibited a moderate (2-level) reaction during the induction phase, application was moved to an adjacent site. Applications were discontinued for the remainder of this test phase, if a moderate (2-level), marked (3-level) or severe (4-level) reaction was observed on this new test site.
Challenge phase:
Approximately two weeks after the final induction path application, a challenge patch was applied for 24 hours to a virgin test site adjacent to the original induction patch site. The patch was removed and the site was scored 24 and 72 hours post-application.
EXAMINATIONS
- Grading/Scoring system:
0 = No visible skin reaction
+ = Barely perceptible or spotty erythema
1 = Mild erythema covering most of the test site
2 = Moderate erythema, possible presence of mild edema
3 = Marked erythema, possible edema
4 = Severe erythema, possible edema, vesiculation, bullae and/or ulceration
- Statistical analysis: not performed.
Results and discussion
- Results of examinations:
- SYMPTOMS
- Frequency, level, duration of symptoms observed: 0
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 210
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0
Applicant's summary and conclusion
- Conclusions:
- In a human repeated insult patch test, conducted with adherence to the applicable ICH Guideline E6 for Good Clinical Practice and requirements provided for in 21 CFR parts 50 and 56, no skin reactions were observed after repeated dermal exposure under occlusive conditions when MTDID 3520 = 3M (TM) Cosmetic Fluid CF-76 is coming in contact with human skin.
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