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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 700-762-0 | CAS number: -
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1995-07-05 to 1995-11-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study was conducted according to OECD guideline 404 and was GLP compliant.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Tridecene
- EC Number:
- 246-919-2
- EC Name:
- Tridecene
- Cas Number:
- 25377-82-6
- Molecular formula:
- C13H26
- IUPAC Name:
- tridecene
- Details on test material:
- This substance is very similar with regard to health endpoints to the substance being registered.
- Name of test material (as cited in study report): Neodene 13
- Substance type: C13 isomerised olefin
- Physical state: Liquid
- Composition of test material, percentage of components: 100% Neodene 13
- Storage condition of test material: Room temperature
-Purity: 100%
- Other: A sufficient amount of test material was transferred from its original container to a labelled storage vessel. A stir bar was added, and the test material was maintained on a magnetic stir plate prior to dispensation and throughout the dosing procedure.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Products, Inc. Denver, PA
- Weight at study initiation: 3349 to 3986 grams at initiation of dosing
- Housing: Individual suspended wire-mesh cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.7 to 20.2°C
- Photoperiod (hrs dark / hrs light): 12 hours light/ 12 hours dark
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 millilitre - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Mortality: The rabbits were observed twice daily (morning and afternoon) for mortality for the duration of the study.
Dermal: Approximately 30 to 60 minutes and 24, 48 and 72 hours after patch removal and daily thereafter through day 21 if irritation persisted.
The Primary Dermal Irritation Index was calculated from scores recorded at 30 to 60 minutes, 24, 48 and 72 hours after patch removal. The mean scores for erythema and oedema were calculated separately to the nearest tenth and added together. - Number of animals:
- 6 rabbits
- Details on study design:
- TEST SITE
- Area of exposure: 1 inch by 1 inch
- Type of wrap if used: 2-ply gauze patch that was over wrapped with a gauze binder, occluded with plastic wrap and secured with Dermiform® tape. Plastic restraint collars were applied and remained on the animals for the duration of the exposure period.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of four hours exposure sites were wiped with disposable paper towels moistened with deionised water
SCORING SYSTEM: Draize method
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 to 72 hours
- Score:
- 2.33
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 to 72 hours
- Score:
- 0.89
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Score:
- 3.5
- Max. score:
- 8
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- According to Draize, Neodene 13 received a descriptive rating classification of “moderately irritating” when applied to the skin of rabbits.
- Executive summary:
Justification for Read Across
Several criteria justify the use of the read across approach to fill data gaps for Category C isomerised olefins using tridecene as an analogue. Tridecene is an isomerised olefin; however, it is not a substance covered under the Higher Olefins and Poly Alpha Olefins Consortium. Therefore, tridecene’s chemical structure, as well as mammalian health endpoints, are comparable to other Category C isomerised olefins. Therefore, read across between tridecene and Category C isomerised olefins can be justified.
In a primary dermal irritation study, 6 male and female New Zealand White rabbits were dermally exposed to 0.5 millilitres of Neodene 13 for 4 hours. Animals then were observed for 1, 24, 48, 72 hours, and then daily thereafter for 21 days. Irritation was scored by the method of Draize.
Exposure sites were examined for erythema and oedema. The mean score (24 -72 hours) for erythema/eschar was 2.33, and 0.89 was the mean score for edema.In this study, Neodene 13 was found to be moderately irritating to the skin based on the calculated Primary Dermal Irritation Index.
This study received a Klimisch score o f one and is classified as reliable without restriction because This study was conducted according to OECD guideline 404 and was GLP compliant. This study will influence the DNEL(s).
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.