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Diss Factsheets
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EC number: 204-683-8 | CAS number: 124-13-0
- 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
- Study period:
- 13 April 1964 to 9 October 1964
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Extensive human volunteer study giving negative results and supporting the conclusions of several animal models, but details of the study design and methods involved in the HRIPT are limited given the age of the study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 964
- Report date:
- 1964
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: The method was a modification of the Draize test published in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, 1959.
- Principles of method if other than guideline:
- Human volunteer repeat insult patch test to determine irritative or sensitising potential. The method was a modification of the Draize test published in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, 1959.
- GLP compliance:
- no
Test material
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 44 started the study and 41 completed
- Sex: 9 males and 32 females
- Age: males in range of 16 to 50 and females in range 16-60
- Race: no data
- Demographic information: no data - Clinical history:
- No information
- Controls:
- No details
- 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: An inch-square Webril (absorbent non-woven cotton fabric) patch covered by adhesive elastic bandage.
- Vehicle / solvent: no data
- Concentrations: no data
- Volume applied: 0.5 ml per patch
- Testing/scoring schedule: nine induction patches applied in three consecutive weeks (24 h applications on Mon, Wed and Fri), reactions scored after bandage removal. The challenge patch was applied in week 6 - 24 h semi-occluded application that was scored 48 and 96 hours after application
- Removal of test substance: No information
- Other: Initially ten subjects were placed on study and additional subjects comitted if no adverse reactions observed to bring up to about 40 subjects
EXAMINATIONS
- Grading/Scoring system: modified Draize system for erythema and oedema
- Statistical analysis: no information
Results and discussion
- Results of examinations:
- SYMPTOMS
- Frequency, level, duration of symptoms observed: No reactions observed
NO. OF PERSONS WITH REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: none
- Number of subjects with negative reactions 41/41
- Number of subjects with equivocal reactions none
- Number of subjects with irritating reactions none
RESULT OF CASE REPORT:
OTHER RESULTS:
Applicant's summary and conclusion
- Conclusions:
- Octanal did not elicit any irritation reactions during the induction phase and no signs of skin sensitisation following challenge
- Executive summary:
41 human volunteer subjects were exposed in nine induction applications to octanal over a 3 -week period and after approximately two weeks rest, the subjects were challenged under a 24 hour semi-occluded patch. No reactions were evident in any of the subjects during the induction and no reactions indicative of sensitisation were apparent following the challenge application.
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