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EC number: 307-301-9 | CAS number: 97593-01-6
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008-01-30 to 2008-04-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable without restriction because the study was conducted similar to OECD 406 guidelines and is GLP compliant.
- 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:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was conducted in accordance with OECD and EU test guidelines applicable at the time of undertaking.
Test material
- Reference substance name:
- Alkenes, C20-24
- IUPAC Name:
- Alkenes, C20-24
- Details on test material:
- - Name of test material (as cited in study report): ENORDET O241
- Physical state: liquid, colourless
- Storage condition of test material: room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River (F-69592 L'Arbresle)
- Age at study initiation: four weeks
- Weight at study initiation: Between 347 to 271 grams
- Housing: groups of two or three in makrolon cages with woodflakes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 23 degrees Celsius
- Humidity (%): 42 to 60%
- Air changes (per hr): at least ten changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light
IN-LIFE DATES: From: To: Not provided
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: olive oil and liquid paraffin
- Concentration / amount:
- Intradermal Induction: 100% of test material
Topical Induction: 100% of test material
Topical Challenge: 12.5 and 6.25% in liquid paraffin
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: olive oil and liquid paraffin
- Concentration / amount:
- Intradermal Induction: 100% of test material
Topical Induction: 100% of test material
Topical Challenge: 12.5 and 6.25% in liquid paraffin
- No. of animals per dose:
- Ten test animals and five control
- Details on study design:
- RANGE FINDING TESTS:
Yes. 2 animals intradermal induction, 2 animals topical induction, and 3 animals topical challenge.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1 exposure
- Exposure period: 48 hours
- Test groups: 10 animals
- Control group: 5 animals
- Site: shoulder
- Frequency of applications: Single application
- Concentrations: 100% test material
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1
- Exposure period: 24 hours
- Test groups: 10 animals
- Control group: 5 animals
- Site: left and right shorn flanks
- Concentrations:
- Evaluation (hr after challenge): Approximately 24 to 48 hours
OTHER: Test material concentration for the challenge phase was 12.5% in liquid paraffin for one side of the flank and 6.25% (v/v) in liquid paraffin on the opposite skin site on the shorn flank. - Challenge controls:
- 5 control animals.
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: Challenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 12.5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: Challenge. . Hours after challenge: 24.0. Group: test group. Dose level: 12.5%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: Challenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 12.5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: Challenge. . Hours after challenge: 48.0. Group: test group. Dose level: 12.5%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: Challenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 6.25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: Challenge. . Hours after challenge: 24.0. Group: test group. Dose level: 6.25%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: Challenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 6.25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: Challenge. . Hours after challenge: 48.0. Group: test group. Dose level: 6.25%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: Challenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: other: Challenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- other: Challenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: other: Challenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitising
- Conclusions:
- The study authors concluded that test material produced a 0% (0/10) skin sensitization rate in the female albino guinea pigs.
- Executive summary:
In a guinea pig maximization skin test, concentrations for the main study were determined by “sighting tests” in which groups of guinea pigs were treated with various concentrations of test material.
Based on the outcome of the “sighting tests”, a group of 15 female guinea pigs were used in the main study with 10 serving as test animals and 5 as controls. In the induction phase, immediately before treatment, on day 0, the animals were clipped free of hair on the shoulder region and a row of three injections comprised of 0.1 mL Freund's Complete Adjuvant plus isotonic sodium chloride in the ratio 1:1, 100% of the test material, and a 50% formulation of the test material 1:1 preparation of Freund's Complete Adjuvant plus olive oil, on each side of the spine.A week later (day 7), the scapular region of all test and control animals was shaved and was brushed with a solution of sodium lauryl sulfate at 10% in thick vaseline, in order to create a local irritation. On Day 8 the same area on the shoulder region was previously for intradermal injetions was clipped again and treated with a topical application of the test material formulation. The topical application of the test material was 100% under occlusive dressing, which was kept in place for 48 hours. The degree of erythema and oedema was determined 24 hours later after the patches were removed using the Draize scale (1977).The induction of the control animals was performed identical to that used for the test animals except that the test material was omitted from the intradermal injections.
The challenge phase applied the test material formulation at 12.5% in liquid paraffin to the flanks of the each animal. The flanks were clipped free of hair. The test material was applied to one side of the shorn flank of each animal under occlusive dressing. To ensure that maximum non-irritant concentration was used in the challenge phase, the test material at a concentration of 6.25% (v/v) in liquid paraffin was also similarly applied to a separate skin site on the opposite shorn flank of the animals. These patches were also occluded to keep the test material in contact with the skin. After a 24 hour contact period, the dressing was carefully removed and the challenge sites were cleaned if required. Approximately 24, and 48 hours after removal of the challenge dressing, the degree of erythema and oedema was quantified using the Draize scale (1977). Any other toxicologically relevant reactions were also noted.
In the preliminary sighting tests no skin reactions were noted at the intradermal induction sites following treatment with the test material at concentrations of 100%, 50%, 25%, 12.5%, 6.25% and 3.125%. The concentration chosen for use in the Intradermal Induction phase of the main test was 100%. Well defined erythema was noted at the topical induction sites of the preliminary sighting test after treatment with 100% test material concentration. Slight erythema was noted at the test site for the 50% test material concentration as well as at 25% test material concentration. No skin reactions were noted at the topical induction sites for the 12.5% test concentration sites. No skin reactions were noted at the topical challenge sites of the preliminary sighting test animals following treatment with the test material at concentrations of 12.5%, 6.25%, 3.125% and 1.56%.
No skin reactions were noted at the topical challenge site of the 6.25% or 12.5% in liquid paraffin test or control group animals at the 24 and 48 -hour observations.
Following topical challenge, no skin reactions were noted at the challenge sites of the test or control animals at the 24 and 48 hour observation period. Animal body weight increases were comparable to those noted in the control group over the course of the study. Based on these results, the study authors concluded that test material produced a 0% (0/10) sensitization rate in the female albino guinea pigs.
This study received a Klimisch score of 1 and was classified as reliable without restriction because the study was conducted similar to OECD 406 testing guidelines and is GLP compliant.
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