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EC number: 204-435-9 | CAS number: 120-92-3
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The test substance purity was known. The screening protocol was well described even if GLP were not validated.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- only 5 animals were used in the treatment group
- Principles of method if other than guideline:
- Method: other: screening protocol similar to OECD guide-line 406 "skin sensitisation"
- GLP compliance:
- no
- Remarks:
- screening test
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- In vivo test was made in 1999 before the in vitro test strategies.
Test material
- Reference substance name:
- Cyclopentanone
- EC Number:
- 204-435-9
- EC Name:
- Cyclopentanone
- Cas Number:
- 120-92-3
- Molecular formula:
- C5H8O
- IUPAC Name:
- cyclopentanone
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- not specified
- Details on test animals and environmental conditions:
- - Source: Harlan Nossan S.r.l., Italy
No more data
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- Induction: 5% in PEG 200 (injection) and 100% (topical)
Challenge: 100 % (first challenge), 20 % in PEG 200 (second challenge)
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- Induction: 5% in PEG 200 (injection) and 100% (topical)
Challenge: 100 % (first challenge), 20 % in PEG 200 (second challenge)
- No. of animals per dose:
- 5
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- type of epicutaneous induction: data not available
- SLS application: yes (concentration unknown)
- Exposure period: day 1 (intradermal) and day 8 (epicutaneous)
- Test groups: In an attempt to induce sensitisation, test animals were intradermally injected with an emulsion of Freund's complete adjuvant and the test substance in both the selected vehicle and an emulsion of Freund's complete adjuvant. One week later this was boosted by topical application of the test substance over the injection sites which had been pre-treated with sodium lauryl sulphate to promote an irritant reaction.
- Control group: animals were treated in the same manner but the selected vehicle was used in place of the test substance.
- Site: data not available
- Frequency of applications: on days 1 and 8
- Duration: 8 days
- Concentrations: 5% in PEG 200 (injection) and 100% (topical)
- Rest period: 2 weeks (after the second stage of induction)
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 2 and 3 weeks after the second stage of induction
- Exposure period: data not available
- Test groups: both the vehicle and the test substance
- Control group: both the vehicle and the test substance
- Site: data not available
- Concentrations: 100 % (first challenge), 20 % in PEG 200 (second challenge)
- Evaluation: 24 and 48 h after challenge - Challenge controls:
- no data
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Group:
- test chemical
- Remarks on result:
- other: The test substance did not elicite a sensitisation response in the Guinea pig, there was no evidence of reaction at challenge following a period of induction exposure to cyclopentanone.
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Group:
- negative control
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
Table 1: Results
1st CHALLENGE |
2nd CHALLENGE |
||||
Control Group |
Control Group |
||||
Animal |
Reaction at challenge |
Animal |
Reaction at challenge |
||
Number |
24 Hours |
48 Hours |
Number |
24 Hours |
48 Hours |
423 |
0 |
0 |
423 |
0 |
0 |
425 |
0 |
0 |
425 |
0 |
0 |
427 |
1 |
0c |
427 |
0 |
0 |
Test Group |
Test Group |
||||
Animal |
Reaction at challenge |
Animal |
Reaction at challenge |
||
Number |
24 Hours |
48 Hours |
Number |
24 Hours |
48 Hours |
429 |
0 |
0 |
429 |
0 |
0 |
431 |
1 |
1 |
431 |
0 |
0 |
433 |
0 |
0 |
433 |
0 |
0 |
435 |
1 |
0c |
435 |
0 |
0 |
437 |
1 |
1 |
437 |
0 |
0 |
c = Yellow colouration of skin |
The test substance did not elicite a sensitisation response in the Guinea pig, there was no evidence of reaction at challenge following a period of
induction exposure to cyclopentanone.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance did not elicite a sensitisation response in the Guinea pig, there was no evidence of reaction at challenge following a period of
induction exposure to cyclopentanone. - Executive summary:
In a dermal sensitization study (Nunziata A, 1999) with cyclopentanone (99.8% purity) in PEG 200, Dunkin-Hartley guinea pigs (5 in the test group, 3 in the control group) were tested using the method of maximization.
In an attempt to induce sensitisation, test animals were intradermally injected with an emulsion of Freund's complete adjuvant and the test substance in both the selected vehicle and an emulsion of Freund's complete adjuvant. One week later this was boosted by topical application of the test substance over the injection sites which had been pre-treated with sodium lauryl sulphate to promote an irritant reaction. Control group animals were treated in the same manner but the selected vehicle was used in place of the test substance. Two weeks after the second induction stage, all animals were challenged by topical application of both the vehicle and the test substance. Irritation to the test substance was noted and challenge was repeated 1 week later using the test substance at a lower concentration.
The results indicate that the test substance does not elicit a sensitisation response in the guinea pig, there being no evidence of reaction at challenge following a period of induction exposure to the substance.
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