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Diss Factsheets
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EC number: 214-288-2 | CAS number: 1119-86-4
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Clinical test conducted according to standard method and to GCP. However, the panel size was lower than recommended and there was no information on the purity of the test material
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:
- no guideline followed
- Principles of method if other than guideline:
- In vivo patch test of standard clinical methodology
- GLP compliance:
- yes
- Remarks:
- According to GCP
Test material
- Reference substance name:
- Decane-1,2-diol
- EC Number:
- 214-288-2
- EC Name:
- Decane-1,2-diol
- Cas Number:
- 1119-86-4
- Molecular formula:
- C10H22O2
- IUPAC Name:
- decane-1,2-diol
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 55
- Sex: Male and female
- Age: 16 - 78 years
- Race: Not reported
- Demographic information: Not reported - Clinical history:
- Inclusion criteria:
1. Absence of any visible skin disease which might be confused with a skin reaction from the test material.
2. Prohibition of use of topical or systemic steroids and/or antihistamines for at least seven days prior to study initiation.
3. Completion of a Medical History form and the understanding and signing of an Informed Consent form
4. Considered reliable and capable of following directions.
Exclusion criteria:
1. Ill health.
2. Under doctor'scare or taking medication(s) which could influence the outcome of the study.
3. Females who were pregannt or nursing.
4. A history of adverse reactions to cosmetics or other personal care products. - Controls:
- There were no contemporary controls
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test) ; prick test; RAST; other immunological tests:
ADMINISTRATION
- Type of application: occlusive / semiocclusive /other: Semiocclusive patch
- Description of patch: 1" x 1" absorbent pad with a clear adhesive dressing manufactured by TruMed Technologies, Inc., Burnsville, MN, USA
- Vehicle / solvent: Not reported
- Concentrations: 0.2 g of test material
- Volume applied: Not reported
- Testing/scoring schedule: Induction patches were applied in the same location three times per week for a total of nine applications and the skin area was assessed at the removal ofeach patch. The challenge patch was applied two weeks after the final induction patch and was applied to a virgin test site.
- Removal of test substance: Not reported
- Other: Applications were discontinued if a moderate (level 2) reaction was observed on the new test site or if marked (level 3) or severe (level 4) reactivity was noted.
EXAMINATIONS
- Grading/Scoring system: 0 = No visible skin reaction; + = Barely perceptible or spotty eryhthema; 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 conducted
Results and discussion
- Results of examinations:
- SYMPTOMS
- Frequency, level, duration of symptoms observed: No symptoms were reported for any of the individuals
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: None
- Number of subjects with negative reactions: 55
- Number of subjects with equivocal reactions: None
- Number of subjects with irritating reactions: None
RESULT OF CASE REPORT: All observations remained within normal limits throughout the test interval
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, the test material Ref# AM1-0049 did not indicate a potential for dermal irritation or allergic contact sensitisation.
- Executive summary:
Observations of the skin beneath the applied patches at 24 and 72 hours post application of the challenge patch revealed observations which were considered to be within normal limits throughout the test interval. Under the conditions of this study, Decan-1,2-diol (AM1 -0049) did not indicate a potential for dermal irritation or allergic contact sensitisation.
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