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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- 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 1995-10-31
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable without restriction because it closely followed OECD guideline 406 and was GLP compliant.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of study:
- other: Modified Buehler
Test material
- Reference substance name:
- Tridecene
- EC Number:
- 246-919-2
- EC Name:
- Tridecene
- Cas Number:
- 25377-82-6
- IUPAC Name:
- tridec-1-ene
- 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 Internal Olefin
- Substance type: C13 isomerised olefin
- Physical state: Clear, colourless liquid
- Analytical purity: 100%
- Lot/batch No.: LR# 22678-33-B
- Storage condition of test material: Original container at room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Sprague Dawley, Incorporated, Indianapolis, Indiana
- Age at study initiation: Young adult
- Weight at study initiation: 302 to 380 grams
- Housing: Individual suspended wire-mesh cages.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 7 days minimum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 71.6 to 72.2 degrees Fahrenheit
- Humidity (%): 39.2 to 47.7%
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light
IN-LIFE DATES: From:1995-08-03 To: 1995-10-02
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone
- Concentration / amount:
- Primary Irritation Phase: 2.5, 5, 10, 25, 50% tridecene prepared in acetone and 100% Neodene 13
Induction Phase: 100% tridecene
Challenge Phase: 5% tridecene prepared in acetone
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone
- Concentration / amount:
- Primary Irritation Phase: 2.5, 5, 10, 25, 50% tridecene prepared in acetone and 100% Neodene 13
Induction Phase: 100% tridecene
Challenge Phase: 5% tridecene prepared in acetone
- No. of animals per dose:
- Primary Irritation Phase: 4 male, 4 female
Induction Phase: 10 male, 10 female
Challenge Phase: 10 male , 10 female - Details on study design:
- RANGE FINDING TESTS: A primary irritation phase was conducted to determine the concentration used for the induction and challenge phase of the study.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: 20 guinea pigs (10 male, 10 female)
- Control group: Positive control group (6 male, 6 female); Naive control group (6 male, 6 female)
- Site: dorsal trunk and flank (3 sites/animal)
- Frequency of applications: Once per week
- Duration: 3 weeks
- Concentrations: 100% tridecene 13 (test group); 0.25% weight/volume DNCB in 80% ethanol (positive control)
- Other : administered at 0.4 mL/site
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2
- Exposure period: 6 hours
- Test groups: 20 guinea pigs (10 male, 10 female)
- Control group: 12 guinea pigs for positive control (6 male, 6 female) and 12 guinea pigs for naive control (6 male and 6 female)
- Site: right flank
- Concentrations: 5% tridecene in acetone
- Evaluation (hr after challenge): 24 and 48 hours - Challenge controls:
- Naive and positive control groups were used. The positive control material , dinitrochlorobenzene (DNCB) was prepared for challenge dosing as a 0.1% weight/volume solution in 80% ethanol and administered at 0.4 mL/site.
- Positive control substance(s):
- yes
- Remarks:
- Dinitrochlorobenzene (DNCB)
Study design: in vivo (LLNA)
- Statistics:
- No statistical methods were reported in the study report.
Results and discussion
- Positive control results:
- The positive control, dinitrochlorobenzene (DNCB), was demonstrated to be an extreme sensitising agent under the conditions of this study based on a Sensitising Incidence Index of 100%.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5% tridecene
- No. with + reactions:
- 3
- Total no. in group:
- 12
- Clinical observations:
- Very slight erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 5% tridecene. No with. + reactions: 3.0. Total no. in groups: 12.0. Clinical observations: Very slight erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5% tridecene
- No. with + reactions:
- 2
- Total no. in group:
- 12
- Clinical observations:
- Very slight erythema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 5% tridecene. No with. + reactions: 2.0. Total no. in groups: 12.0. Clinical observations: Very slight erythema.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5% tridecene
- No. with + reactions:
- 3
- Total no. in group:
- 19
- Clinical observations:
- Very slight erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5% tridecene. No with. + reactions: 3.0. Total no. in groups: 19.0. Clinical observations: Very slight erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5% tridecene
- No. with + reactions:
- 4
- Total no. in group:
- 19
- Clinical observations:
- Very slight erythema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5% tridecene. No with. + reactions: 4.0. Total no. in groups: 19.0. Clinical observations: Very slight erythema.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1% DNCB
- No. with + reactions:
- 12
- Total no. in group:
- 12
- Clinical observations:
- Moderate to severe erythema and varied levels of oedema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.1% DNCB. No with. + reactions: 12.0. Total no. in groups: 12.0. Clinical observations: Moderate to severe erythema and varied levels of oedema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.1% DNCB
- No. with + reactions:
- 12
- Total no. in group:
- 12
- Clinical observations:
- Moderate to severe erythema and varied levels of oedema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.1% DNCB. No with. + reactions: 12.0. Total no. in groups: 12.0. Clinical observations: Moderate to severe erythema and varied levels of oedema.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Tridecene produced a Sensitisation Incidence Index of 0/19 (0%) and is considered not to be a dermal sensitizer to albino guinea pigs.
- Executive summary:
Justification for Read Across
Several criteria justify the use of the read across approach to fill data gaps for single carbon number isomerised olefins using tetradecene as an analogue. Tetradecene is a single carbon number isomerised olefin; however, it is not a substance included under the Higher Olefins and Poly Alpha Olefins Consortium. However, tetradecene's chemical structure, physico-chemical properties, and mammalian health endpoints are comparable with other single carbon number isomerised olefins. Therefore, read across between tetradecene and single carbon number isomerised olefins can be justified
.
In a dermal sensitisation study using tridecene, young adult albino Hartley guinea pigs (10 male, 10 female) were tested using a modified Buehler method. The study utilized three tiers of testing: the primary irritation phase, induction phase, and the challenge phase. The primary irritation phase determined irritation thresholds for tridecene using test dose concentration of 2.5, 5, 10, 25, 50 and 100% tridecene in acetone. The induction phase exposed 20 test animals to tridecene 13 (100%) under occlusion for 6 hours once per week, for 6 hours, for three weeks, for a total of three exposures. To detect sensitisation, animals were administered a topically challenged dose of tridecene (5% prepared in acetone). The challenge dose was administered following a two week rest period after the induction phase. Reactions to the primary, induction and challenge phase were observed 24 to 48 hours after completion of exposure and graded according to the Draize scale. A positive control group (dinitrochlorobenzene) and naïve control group were included for induction and challenge dosing respectively.The Sensitisation Incidence Index was used to determine sensitisation. In the primary irritation phase, administration of 5% tridecene induced very slight erythema at 24 and 48 hours post exposure in 3 to 4 animals, respectively. Four animals treated with 100% tridecene 13 showed very slight to slight erythema and oedema reactions at 24 hrs, while slight erythema and 2 very slight oedema reactions were observed in 4 animals at 48 hours. Based on these results, the study authors determined 100% tridecene to be appropriate for the induction phase. A 5% test solution of tridecene in acetone was considered to be the maximal nonirritating concentration and was used for challenge dosing.
Slight erythema was noted in the test group following the challenge dose of 5% tridecene at 24 and 48 hours post-exposure. No incidences of oedema were reported. In the naïve control group, very slight erythema was observed at 24 and 48 hours. The authors reported one animal death from the test group on day 28 prior to challenge dosing which was considered to be isolated and unrelated to the test material. The positive control (DNCB) produced the expected results at challenge.
Based on these study results, the authors calculated a Sensitization Incidence Index to be 0/19 (0%) for the test chemical following the challenge dose administration. The authors concluded that based on the 0% Sensitisation Incidence Index, tridecene was nonsensitising to albino guinea pigs under the testing conditions outlined in the study.
This study received a Klimisch score of 1 and is classified as reliable without restriction because it closely followed OECD guideline 406 and was GLP compliant. This study will influence the DNEL(s).
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