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EC number: 203-894-2 | CAS number: 111-67-1
- 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
Direct observations: clinical cases, poisoning incidents and other
Administrative data
- Endpoint:
- direct observations: clinical cases, poisoning incidents and other
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1992-05-11 to 1992-05-13
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable with restrictions because while there is no statement regarding whether this study was conducted according to GLP or equivalent, the study is well documented and scientifically acceptable.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in Section 13.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
Materials and methods
- Study type:
- study with volunteers
- Endpoint addressed:
- skin irritation / corrosion
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other:
- Deviations:
- no
- Principles of method if other than guideline:
- Hilltop Research used their study protocol "Evaluation of Primary Irritation Potential in Humans, Single 24-Hour Application" for this study.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 1-octadecene
- IUPAC Name:
- 1-octadecene
- Reference substance name:
- Octadec-1-ene
- EC Number:
- 204-012-9
- EC Name:
- Octadec-1-ene
- Cas Number:
- 112-88-9
- Molecular formula:
- C18H36
- IUPAC Name:
- octadec-1-ene
- Details on test material:
- - Name of test material (as cited in study report): Neodene 18 (WRC Tox sample 1174)
- Substance type: C18 alpha olefin
Constituent 1
Constituent 2
Method
- Type of population:
- general
- Subjects:
- 18 total; 12 females and 6 males
- Ethical approval:
- confirmed and informed consent free of coercion received
- Route of exposure:
- dermal
- Reason of exposure:
- intentional
- Details on exposure:
- Subjects were administered the test material to both the right and left arms. Application sites were then covered witha semi-occluded patch. Exposure continued for 24 hours, afterwhich the patch was removed. Test sites were scored 30 minutes after patch removal.
- Examinations:
- Test sites were scored 30 minutes after patch removal. Patch sites were scored according to the scoring scale provided in the study report.
- Medical treatment:
- No data reported.
Results and discussion
- Clinical signs:
- Clinical signs were not reported.
- Results of examinations:
- SYMPTOMS
- Frequency, level, duration of symptoms observed: moderate to strong eythema, oedema and papules were observed in majority of the test subjects when exposed to the 100% dilution of Neodene 18 30 minutes post application. These symptoms of application were also observed at the 24 hour observation.
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 17/18 for the 100% dilution.
- Number of subjects with negative reactions: 1/18 for the 100% dilution
RESULT OF CASE REPORT: Strong clinical irrtiation was observed when Neodene 18 was applied at the 100% v/v dilution. Clinical irritation was not observed for the same when applied at the 1%, 10%, and 25% v/v dilution. - Effectivity of medical treatment:
- No data reported.
- Outcome of incidence:
- No data reported.
Any other information on results incl. tables
Table 1. 24-hour Irritation Scores for Neodene®18 |
|
Dose (Neodene 18 % v/v in mineral oil) |
Average Irritation Score |
100% |
4.28 (1.41) |
25% |
0 |
10% |
0 |
1% |
0 |
Positive Control – SLS (0.25% v/v) |
0.22 (0.73) |
N = 18
Values in parenthesis represent standard deviationApplicant's summary and conclusion
- Conclusions:
- Diluted solutions of Neodene 18 (1%, 10%, and 25%) produced no evidence of dermal irritation in humans when applied via a semi-occluded patch for 24 hours. Undiluted Neodene 18 produced moderate to severe erythema, edema, and papules under the same test conditions.
- Executive summary:
In a dermal irritation study using Neodene 18 diluted (1, 10, and 25% in mineral oil) and undiluted, humans (12 females and 6 males) wereexposed to a single patch application for each test concentration on the upper arm (right and left) for 24 hours. Sodium lauryl sulfate (0.25% in distilled water) served as the positive control. Reactions were scored 30 minutes and 24 hours after patch removal using a numerical and letter grade to indicate severity and type of reaction. The test conditions were appropriate for this study type.
Thirty minutes after patch removal, moderate to strong erythema, edema, and papules were observed on test sites of sixteen subjects exposed to undiluted Neodene 18 with the irritation spreading beyond the test area in six of the subjects. Twenty-four hours after patch removal, seventeen of the test sites exhibited moderate to strong erythema, edema, and papules with the irritation spreading beyond the test sites in nine of the subjects. Diluted solutions of Neodene 18 (1%, 10%, and 25%) produced no evidence of dermal irritation in humans when applied via a semi-occluded patch for 24 hours. Undiluted Neodene 18 produced moderate to severe erythema, edema, and papules under the same test conditions.
This study received a Klimisch score of 2 and is classified as reliable with restrictions because while there is no statement regarding whether this study was conducted according to GLP or equivalent, the study is well documented and scientifically acceptable.
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