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Diss Factsheets
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EC number: 807-157-1 | CAS number: 129677-93-6
- 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
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable well-documented study report which meets basic scientific principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- Induction: Patches were applied three times a week on the back of human volunteers for a total of nine applications.
Challenge: Approximately after two weeks of rest period after the final induction patch removal a challenge patch was applied for 24 hours. The site was scored 24 and 72 hours after application. - GLP compliance:
- yes
Test material
- Reference substance name:
- Octyl octanoate
- EC Number:
- 218-980-5
- EC Name:
- Octyl octanoate
- Cas Number:
- 2306-88-9
- Molecular formula:
- C16H32O2
- IUPAC Name:
- octyl octanoate
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- confirmed and informed consent free of coercion received
- Subjects:
- - Number of subjects exposed: 111
- Sex: male (28) and female (83)
- Age: 18 - 79 years - Clinical history:
- - Other:
INCLUSION CRITERIA:
a. male and female subjects, age 16 and above
b. Absence of any visible 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. - Controls:
- no controls
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: semiocclusive
- Description of patch: 3/4'' x 3/4'' absorbent pad portion of an adhesive dressing
- Vehicle / solvent: corn oil
- Concentrations: 12.5 %
- Volume applied: 0.2 mL or an amount sufficient to cover contact surface
- Testing/scoring schedule: Induction exposure 3 times per week (Monday, Wednesday, Friday) for a total of nine applications, scoring was done shortly before application of a new patch, 24 hours after removal (Monday and Wednesday application) and 48 hours (Friday application); challenge exposure was done 2 weeks after removal of the last induction patch, challenge exposure lasted 24 hours, scoring was done after removal of patch and 8 hours later
- Removal of test substance: no
EXAMINATIONS
- Grading/Scoring system:
0 = No visible skin reaction
0.5/+ = Barely perceptible
1 = Mild
2 = Moderate
3 = Marked
4 = Severe
E = Edema
D = Dryness
S = Staining
P = Papules
V = Vesicles
B = Bullae
U = Ulceration
Sp = Spreading
Results and discussion
- Results of examinations:
- SYMPTOMS
- Frequency, level, duration of symptoms observed: no symptoms observed
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with negative reactions: 105
OTHER RESULTS:
- 105 of the 111 volunteers concluded the study. The remaining subjects discontinued their participation for various reasons, none of which were related to the application of the test material.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study the test material did not indicate a potential for dermal irritation or allergic contact sensitization.
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