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EC number: 401-700-2 | CAS number: 3100-36-5 CYCLOHEXADECENON; CYCLOHEXADECENONE
- 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:
- 1986-06-19 to 1986-09-03
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- According to draft OECD 406 and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 086
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- According to draft OECD 406 and GLP, but topical induction used 25% non irritating concentration without SLS pretreatment and challenge concentration of 5% could have been chosen higher.
- Principles of method if other than guideline:
- - Principle of test: Guinea pig maximisation test according to draft OECD 406
- Short description of test conditions: Test conditions were chosen according to OECD 406, but topical induction used 25% non irritating concentration without SLS pretreatment and challenge concentration of 5% could have been chosen higher. - GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The test was carried out before entry into force of Regulation (EC) No 1907/2006, and meet the requirements set out in Article 13(3), first subparagraph and Article 13(4). Thus, this Guinea Pig Maximisation Test shall be considered appropriate to address this standard information requirement for skin sensitisation.
Test material
- Reference substance name:
- A mixture of cis- and trans-cyclohexadec-8-en-1-one
- EC Number:
- 401-700-2
- EC Name:
- A mixture of cis- and trans-cyclohexadec-8-en-1-one
- Cas Number:
- 3100-36-5
- Molecular formula:
- C16H28O
- IUPAC Name:
- (8E)-cyclohexadec-8-en-1-one; (8Z)-cyclohexadec-8-en-1-one
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: SPF-bred, albino guinea pigs (Bor:DHPW)
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Females nulliparous and non-pregnant: Yes
- Microbiological status of animals: SPF
- Age at study initiation: Young
- Weight at study initiation: 281-329 g (males), 280-330 g (females)
- Housing: Individually under conventional conditions in suspended, stainless steel cages, fitted with wire mesh floor and front
- Diet: Ad libitum (pelleted, natural ingredient diet)
- Water: Ad libitum (unfluoridated tap water)
- Acclimation period: 5 days
- Indication of any skin lesions: No visible skin abnormalities
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 + 2
- Humidity (%): 40-70
- Air changes (per hr): At least 10
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: From day 0 to day 23
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- Intradermal
- two injections (0.1 mL) with Freund's Complete Adjuvant (FCA)
- two injections (0.1 mL) with a 25% dilution (v/v) of the test item in PG
- two injections (0.1 mL) with a 25% dilution (v/v) of the test item in FCA and PG (1:1)
Epicutaneous
25% (w/w) mixture of the test substance with vaseline - Day(s)/duration:
- 7 days (from intradermal injection to topical application) + 48 hours (topical application) + 12 days from removal of topical application until challenge
- Adequacy of induction:
- other: Intradermal injections induced moderate to severe erythema and abscesses in all test animals. The topical applications did not induce any reactions.
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Vaseline
- Concentration / amount:
- 5%
- Day(s)/duration:
- 1 day
- Adequacy of challenge:
- other: The challenge treatment with the 5% dilution of the test substance in vaseline did not induce skin reactions in any of the test animals or the controls, either after 24 h or after 48 h.
- No. of animals per dose:
- 10 animals per sex were treated with a single dose of the test item or with a control treatment
- Details on study design:
- RANGE FINDING TESTS: The irritation response upon intradermal injection of various concentrations was examined in 3 guinea pigs. A sufficiently lange area of the scapular region was clipped free of hair with electric clippers. Subsequently 0.1 mL portions of 5, 10 and 25% (v/v) dilutions of the test substance in propylene glycol (PG), were applied to each animal by intradermal injection. Skin readings were made after 24 h. A dilution causing slight to moderate irritation is usually taken for intradermal injection of the test substance in the induction phase of the main test. The irritation response upon topical treatment was tested in 6 other guinea pigs. Both flanks of each animal were clipped free of hair with electric clippers. Subsequently several 2 x 2 cm patches of filter paper (Whatman No. 3 MM) were loaded with different concentrations of the test substance in vaseline, viz. 5, 10 or 25% (w/w). The patches were placed an the clipped skin and covered with a piece of PVC foil and hypo-allergenic paper bandage (Leukopor) which was then secured by elastic adhesive bandage (Tensoplast), 7.5 cm in width, wound around the torso of the animal. One concentration was tested in two animals. The dressing was left in place for 24 h. Then the animals were examined for signs of irritation. A concentration causing slight to moderate irritation is usually chosen for topical induction and a non-irritant concentration for topical challenge.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Two (intradermal injections and one week later, a topical application over the injection sites)
- Exposure period: 9 days (7 days after intradermal injection, a topical induction was left in place for 48 h)
- Test groups: One test group was treated with three pairs of simultaneous intradermal injections:
two injections (0.1 mL) with Freund's Complete Adjuvant (FCA)
two injections (0.1 mL) with a 25% dilution (v/v) of the test substance in PG
two injections (0.1 mL) with a 25% dilution (v/v) of the test substance in FCA and PG (1:1)
- Control group: One control group was treated with three pairs of simultaneous intradermal injections:
two injections (0.1 mL) with FCA
two injections (0.1 mL) with PG
two injections (0.1 mL) with FCA and PG (1:1)
One week after the intradermal injections, the induction by topical application was made in the same region. A patch of filter paper was loaded with a 25% (w/w) mixture of the test substance with vaseline. The patch was placed over the sites of the intradermal injections and was secured. The dressing was left in place for 48 hours. The control animals were similarly treated with patches loaded with vaseline only. Skin readings were made directly after removal of the patches.
- Site: Scapular region
- Duration: 21 days (7 days from intradermal injection until topical application, 48 hours topical application and 12 days between removal of topical application until challenge)
- Concentrations: 25% (w/w) (intradermal and topical)
B. CHALLENGE EXPOSURE
- No. of exposures: One topical challenge
- Day of challenge: On day 21
- Exposure period: 24 hours
- Test groups: The test group was treated with 5% (w/w) mixture of the test substance with vaseline
- Control group: The control group was treated with 5% (w/w) mixture of the test substance with vaseline
- Site: Right flank of each animal
- Concentrations: 5% (w/w) mixture of the test substance with vaseline
- Evaluation (hr after challenge): 24 and 48 - Challenge controls:
- Vaseline
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- Not tested
- Remarks on result:
- not measured/tested
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- Not tested
- Remarks on result:
- not measured/tested
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- vehicle control during induction, 5% substance during challenge
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- All animals remained in good health during the experimental period.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- vehicle control during induction, 5% substance during challenge
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- All animals remained-in good health during the experimental period.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% during induction, 5% substance during challenge
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- All animals remained-in good health during the experimental period.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% during induction, 5% substance during challenge
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- All animals remained-in good health during the experimental period.
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a Guinea Pig Maximisation Test similar to OECD guideline 406, the test item was not sensitising under the conditions of the test.
- Executive summary:
The test substance was examined for possible sensitizing properties by a maximization test in guinea pigs using 20 test animals and 20 controls. The test was conducted according to the draft OECD 406 guideline and GLP.
The test comprised:
1) induction treatment by intradermal injection of 25% test substance in propylene glycol, followed one week later by topical treatment with 25% in vaseline
2) challenge treatment, 14 days after the last induction, by topical application of 5% in vaseline
The challenge treatment with the 5% dilution did not induce signs of sensitization in any of the guinea pigs under the conditions of the test. Therefore, it was concluded that the test substance is a non-sensitizer.
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