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EC number: 246-922-9 | CAS number: 25378-22-7
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1995-11-13 to 1995-11-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable without restrictions because it was conducted according to GLP guidance and OECD 405 guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Alkenes, C6-8
- IUPAC Name:
- Alkenes, C6-8
- 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): Shop C68 Internal Olefin
- Substance type: Alkenes, C6-8
- Physical state: Clear colourless liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Froxfield SPF Rabbits, Broadway Farm, Froxfield, Hampshire, England
- Age at study initiation: 4 months old
- Weight at study initiation: 2.80 to 3.35 grams
- Housing: Housed individually in suspended stainless steel cages mounted in mobile batteries
- Diet (e.g. ad libitum): Pelleted rabbit food; ad libitum
- Water (e.g. ad libitum): Tap water; ad libitum
- Acclimation period: Approximately 3 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 to 23
- Humidity (%): 40 to 70
- Air changes (per hr): 10 complete air changes/hr without re-circulation
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 millilitre
- Concentration (if solution): Not provided
- Duration of treatment / exposure:
- 72
- Observation period (in vivo):
- 1, 24, 48, and 72 hours
- Number of animals or in vitro replicates:
- 3, including one sentinel animal
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data
SCORING SYSTEM: Appears to have used the Draize method of eye scoring (Draize, 1959).
TOOL USED TO ASSESS SCORE: Ophthalmoscope or pencil beam torch; fluorescein was used, if necessary, to
aid the examination of the cornea
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 hours after instillation
- Score:
- ca. 0.2
- Remarks on result:
- other: The maximum score is not specified in the study report; it is usually 110 if using Draize eye irritation scoring system.
- Irritant / corrosive response data:
- Animals were reported to exhibit slight pain and irritation following instillation of the test material. Corrosive data not reported.
- Other effects:
- Besides initial pain and irritation followed by mild conjunctivitis, no other effects were reported.
Any other information on results incl. tables
Initial instillation of the test compound caused very slight initial pain response. All animals had very slight to slight conjunctivitis within an hour of treatment, but one animal showed persistent response at 48 hours. At 72 hours, all animals’ eyes appeared normal. The study authors concluded that under the study conditions, SHOP C68 internal olefin was a non-irritant to the eye.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Shop 68 was not considered irritating to rabbit eyes.
- Executive summary:
Justification for Read Across
Several criteria justify the use of the read across approach to fill data gaps for Category C substances using Category D substance analogues. Category C is comprised of isomerised olefins. Category D is comprised of isomerised olefins with a range of carbon numbers. Studies indicate that changing the carbon number or the location of the double bond, or adding branching does not measurably alter the mammalian health endpoints. There appears to be no critical difference across Category D isomerised olefins with a range of carbon numbers with regard to health endpoints. Toxicity concerns are low for acute exposure to Category D substances. Genotoxicity studies indicate that these materials are not mutagenic. There was no adverse systemic toxicity observed in a 90-day repeated oral dose study, in which rats were exposed to C20-24 branched and linear alkenes. As a result, all of the above tested mammalian toxicity endpoints indicate a low hazard potential for human health. There do not appear to be any toxicological differences between Category D isomerised olefins with a range of carbon numbers and Category C is comprised of isomerised olefins. Therefore, read across between these two categories can be justified.In an acute eye irritation study, three New Zealand White rabbits (sex note specified) were instilled with 0.1millilitre of Shop 68 in the right eye. The left eye served as control. Following test chemical instillation, the animals were observed for overt signs of toxicity for several minutes and were checked twice during the first hour after treatment and at regular intervals throughout the day and daily to ensure that the treated eyes did not exhibit infection or cause distress. Ocular irritation was scored at 1, 24, 48, and 72 hours after treatment using a method similar to the Draize (1959) eye irritation scoring system.
Initial instillation of the test compound caused very slight initial pain response. All animals had very slight to slight conjunctivitis within an hour of treatment, but one animal showed persistent response at 48 hours. At 72 hours, all animals’ eyes appeared normal. The study authors concluded that under the study conditions, SHOP C68 internal olefin was a non-irritant to the eye.
This study received a Klimisch score of 1 and is classified as “reliable without restrictions” because it was conducted according to GLP guidance and OECD 405 guidelines.
This study will influence the DNEL(s).
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