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EC number: 235-970-6 | CAS number: 13074-65-2
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982-03-18 - 1982-04-29
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study similar to guideline. Limited substance information (e.g. purity).
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- According to the method of Magnusson and Kligman, but predating adoption by OECD as part of TG406
- Deviations:
- no
- GLP compliance:
- not specified
- Remarks:
- The study pre-dates the introduction of GLP in the United Kingdom.
- Type of study:
- guinea pig maximisation test
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Environmental Safety Division (Unilever in-house)
- Age at study initiation: no data.
- Weight at study initiation: about 320g.
- Housing: no data.
- Diet (e.g. ad libitum): no data.
- Water (e.g. ad libitum): no data.
- Acclimation period: no data.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data.
- Humidity (%): no data.
- Air changes (per hr): no data.
- Photoperiod (hrs dark / hrs light): no data.
IN-LIFE DATES: no data. - Route:
- intradermal and epicutaneous
- Vehicle:
- other: For injection, vehicle was physiological saline containing 0.01% sodium dodecylbenzenesulphonate. Topical induction application was neat (no vehicle), and the challenge application was conducted in acetone/PEG.
- Concentration / amount:
- Induction injection, 2%; topical induction, 100% (neat); topical challenge, 25 or 15%.
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: For injection, vehicle was physiological saline containing 0.01% sodium dodecylbenzenesulphonate. Topical induction application was neat (no vehicle), and the challenge application was conducted in acetone/PEG.
- Concentration / amount:
- Induction injection, 2%; topical induction, 100% (neat); topical challenge, 25 or 15%.
- No. of animals per dose:
- 10
- Details on study design:
- RANGE FINDING TESTS: intradermal injection irritation tests were carried out to determine a suitable concentration for the induction of sensitisation. The selected concentration was 2%, in saline containing 0.01% sodium dodecylbenzenesulphonate (DoBS). Covered patch irritation tests were carried out to determine a suitable concentration for sensitisation induction and challenge. As 75% was considered insufficiently irritant, it was decided to use neat test substance.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: two.
- Exposure period: intradermal injection, followed one week later by 48-hour covered patch application.
- Test groups: one, ten animals (6 males, 4 females).
- Control group: 4 males treated with vehicle and 4 females untreated.
- Site: intradermal injections were made to a clipped and shaved area of skin in the dorsal shoulder. Topical patches were applied to a clipped and shaved area of skin on the trunk, behind the forelimbs.
- Frequency of applications: three pairs of intradermal injections; one topical application.
- Duration: topical application for 48-hours, one week after injections.
- Concentrations: intradermal injections (2 of each): 1) 50% Freund's complete adjuvant (FCA) in saline (with 0.01% sodium dodecylbenzenesulphonate); 2) 2% test substance in vehicle; 3) 2% test substance in 50:50 mixture of vehicle and FCA. Topical application: neat (no vehicle).
B. CHALLENGE EXPOSURE
- No. of exposures: three.
- Day(s) of challenge: 13/14 (after application of the induction patch), 21/22 and 28/29.
- Exposure period: 24 hours.
- Test groups: one, ten animals (6 males, 4 females).
- Control group: 4 males treated with vehicle (challenges 1 and 2 only) and 4 females untreated (all challenge exposures).
- Site: a clipped and shaved area of the trunk.
- Concentrations: 25% (challenge 1), 15% (challenge 2 and 3) in acetone/PEG400.
- Evaluation (hr after challenge): 24 and 48 hours after removal of the patches. - Challenge controls:
- Treated controls: 4 males, treated the same way as animals administered the test substance, given a mock induction treatment in which the test substance was omitted.
Untreated controls: 4 females, previously untreated, are treated the same way as test animals at each challenge. - Positive control substance(s):
- no
- Positive control results:
- No data.
- Reading:
- other: Challenge 1 (day 13/14)
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- Reaction questionable
- Remarks on result:
- other: Reading: other: Challenge 1 (day 13/14). . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: Reaction questionable.
- Reading:
- other: Challenge 1 (day 13/14)
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: Challenge 1 (day 13/14). . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: Challenge 2 (day 21/22)
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 15%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: Challenge 2 (day 21/22). . Hours after challenge: 24.0. Group: test group. Dose level: 15%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: Challenge 2 (day 21/22)
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 15%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: Challenge 2 (day 21/22). . Hours after challenge: 48.0. Group: test group. Dose level: 15%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: Challenge 3 (day 28/29)
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 15%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: Challenge 3 (day 28/29). . Hours after challenge: 24.0. Group: test group. Dose level: 15%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: Challenge 3 (day 28/29)
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 15%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: Challenge 3 (day 28/29). . Hours after challenge: 48.0. Group: test group. Dose level: 15%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
- Conclusions:
- Jasmatone (2-n-hexyl cyclopentanone) was found to be not sensitising in a guinea pig maximisation test, according to the method of Magnusson and Kligman.
- Executive summary:
In an in vivo guinea pig maximisation test, according to the method of Magnusson and Kligman but conducted prior to the introduction of GLP or the applicable OECD test guideline, Jasmatone (2 -n-hexyl cyclopentanone) was found to be non sensitising. One, questionable, positive reaction was seen in 1/10 test animals 24 hours after the first challenge application, but no other positive reactions were reported in test animals or vehicle or untreated controls.
Reference
No reactions seen in any control animals (treated or untreated).
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In an in vivo guinea pig maximisation test, Jasmatone (2 -n-hexyl cyclopentanone) was not found to be a skin sensitiser. One, questionable, positive reaction was seen in 1/10 test animals, 24 hours after the first challenge application, but no other positive reactions were reported in test animals or vehicle or untreated controls.
There was also no evidence of a sensitising effect in a second guinea pig maximisation test, nor in a maximisation test in 27 subjects.
Migrated from Short description of key information:
Jasmatone (2-n-hexyl cyclopentanone) was found to be not sensitising in two guinea pig maximisation tests (Unilever, 1982d; 1983) and in a human maximisation test (Epstein, 1980).
Justification for selection of skin sensitisation endpoint:
Reliable in vivo study
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
- Migrated from Short description of key information:
No respiratory sensitisation study available. However, such effects are unlikely as Jasmatone is not a skin sensitiser to guinea pigs and its low volatility indicates that significant inhalation is unlikely under anticipated conditions of use.
Justification for classification or non-classification
Based on negative results in three, reliable in vivo skin sensitisation studies, classification under the EU DSD or CLP regulations is not required.
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