Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 934-268-3 | CAS number: 1285695-48-8
- 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
![](https://www.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1992-06-01 to 1992-07-07
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- 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 protocol was provided and was cited as adapted from the Draize test. Further, the results were 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 source
Reference
- Endpoint:
- sensitisation data (humans)
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- supporting study
- Study period:
- 1992-06-01 to 1992-07-07
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- 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 protocol was provided and was cited as adapted from the Draize test. Further, the results were 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.
- Reason / purpose for cross-reference:
- read-across source
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- There are no guidelines available for human subject testing and this study adapted from the Draize method.
- GLP compliance:
- no
- Type of population:
- general
- Ethical approval:
- confirmed and informed consent free of coercion received
- Subjects:
- - Number of subjects exposed: 36
- Sex: Male and female
- Age: >18 years - Controls:
- Sodium Laurly Sulphate (0.1 % w/v) in distilled water
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: Semi-occlusive
- Vehicle / solvent: Mineral Oil
- Concentrations: 25% in mineral oil
- Volume applied: Not reported
-Testing schedule: Nine applications (24-hours each) were administered three/week over a 3-week period (induction phase), followed by a 10-15 day rest period, then a 24-hour application to both the original and a naïve site (challenge phase). - Results of examinations:
- SYMPTOMS
- Frequency, level, duration of symptoms observed: 24 hours
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 29
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 2 subjects exhibited mild erythema during induction - Conclusions:
- Neodene® 18 does not cause clinical irritation or sensitisation in human subjects.
- Executive summary:
Neodene® 18 (25% in mineral oil) was tested for the potential to induce contact sensitisation upon repeated application under semi-occlusive conditions. Sodium lauryl sulfate (0.1% in distilled water) was used for comparison. The test conditions were appropriate for this study type. Reactions were scored with a numerical and letter grade to indicate severity and type of reaction. Only two of the thirty-one subjects exhibited mild erythema (which was resolved within 24 hours) during the induction phase compared to nine subjects exhibiting mild to moderate erythema after exposure to 0.1% sodium lauryl sulfate. Results indicate that Neodene® 18 does not cause clinical irritation or sensitization in human subjects.
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 protocol was provided and was cited as adapted from the Draize test. Further, the results were well-documented and scientifically acceptable.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- There are no guidelines available for human subject testing and this study adapted from the Draize method.
- GLP compliance:
- no
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 RIR-1174-T)
- Substance type: C18 alpha olefin
Constituent 1
Constituent 2
Method
- Type of population:
- general
- Ethical approval:
- confirmed and informed consent free of coercion received
- Subjects:
- - Number of subjects exposed: 36
- Sex: Male and female
- Age: >18 years - Controls:
- Sodium Laurly Sulphate (0.1 % w/v) in distilled water
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: Semi-occlusive
- Vehicle / solvent: Mineral Oil
- Concentrations: 25% in mineral oil
- Volume applied: Not reported
-Testing schedule: Nine applications (24-hours each) were administered three/week over a 3-week period (induction phase), followed by a 10-15 day rest period, then a 24-hour application to both the original and a naïve site (challenge phase).
Results and discussion
- Results of examinations:
- SYMPTOMS
- Frequency, level, duration of symptoms observed: 24 hours
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 29
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 2 subjects exhibited mild erythema during induction
Applicant's summary and conclusion
- Conclusions:
- Neodene® 18 does not cause clinical irritation or sensitisation in human subjects.
- Executive summary:
Neodene® 18 (25% in mineral oil) was tested for the potential to induce contact sensitisation upon repeated application under semi-occlusive conditions. Sodium lauryl sulfate (0.1% in distilled water) was used for comparison. The test conditions were appropriate for this study type. Reactions were scored with a numerical and letter grade to indicate severity and type of reaction. Only two of the thirty-one subjects exhibited mild erythema (which was resolved within 24 hours) during the induction phase compared to nine subjects exhibiting mild to moderate erythema after exposure to 0.1% sodium lauryl sulfate. Results indicate that Neodene® 18 does not cause clinical irritation or sensitization in human subjects.
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 protocol was provided and was cited as adapted from the Draize test. Further, the results were well-documented and scientifically acceptable.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)