Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 268-706-3 | CAS number: 68133-79-9
- 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:
- December 12, 1991 - January 1, 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Buehler, E.V., Delayed Contact Hypersensitivity in the Guinea Pig., Arch. Dermat. 92: 171-175, 1965.
- Deviations:
- yes
- Remarks:
- The humidity was 52-80% rather than 40-70%. This is not thought to have affected the results.
- GLP compliance:
- not specified
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- This test was performed before the LLNA method was adopted as the preferred method.
Test material
- Reference substance name:
- 2-(3,7-dimethylocta-2,6-dienyl)cyclopentan-1-one
- EC Number:
- 268-706-3
- EC Name:
- 2-(3,7-dimethylocta-2,6-dienyl)cyclopentan-1-one
- Cas Number:
- 68133-79-9
- Molecular formula:
- C15H24O
- IUPAC Name:
- 2-(3,7-dimethylocta-2,6-dienyl)cyclopentan-1-one
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Davidson Mill Farm, Jamesburgh, New Jersey 08831, USA
- Weight at study initiation: 354 - 529 g
- Housing: Stainless steel wire mesh cages, elevated, 1-3 animals per cage
- Diet (e.g. ad libitum): Wayne Guinea Pig Formula ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.3-21.9 degrees C
- Humidity (%): 52-80%
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark
- IN-LIFE DATES: From: December 4, 1991 To: January 9, 1992
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.4 mL
- Day(s)/duration:
- 9 inductions were performed
- Adequacy of induction:
- highest technically applicable concentration used
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.4 mL
- Day(s)/duration:
- 24 hrs
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10
- Details on study design:
- RANGE FINDING TESTS: A screening assessment was performed with animals exposed to 10, 25, 50, 75, and 100% test substance is white mineral oil. As there was only minimal reaction to the 100% substance (one animals showed exfoliation at 24 hrs after the third application), and no reactions at any of the lower concentrations, the full concentration of 100% was used.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 9
- Exposure period: 18 days
- Test groups: 10 animals
- Site: left flank
- Frequency of applications: every other day
- Duration: first induction 24 hrs, inductions 2-9 6 hrs
- Concentrations: 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 33
- Exposure period: 24 hrs
- Test groups: 10 animals
- Control group: 5 animals
- Site: right flank
- Concentrations: 100%
- Evaluation (hr after challenge): 24 and 48 hrs
- Challenge controls:
- 5 naive animals
- Positive control substance(s):
- yes
- Remarks:
- 1-chloro-2,4-dinitrobenzene (0.1% in 50% ethanol and 0.9% saline solution)
Results and discussion
- Positive control results:
- The positive control was determined to be a dermal sensitizer in albino guinea pigs.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- other: 1st and 2nd readings
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.4 mL
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No reactions were noted after the challenge.
- Reading:
- other: 1st and 2nd readings
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Reading:
- other: 1st and 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.1% 1-chloro-2,4-dinitrobenzene
- No. with + reactions:
- 6
- Total no. in group:
- 6
- Clinical observations:
- Erythema (score of up to 3), edema (score of up to 2)
Any other information on results incl. tables
Skin Sensitization – Induction Phase: Reading after Each Application
Animal |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
1 – Erythema |
1 |
0 |
0 |
1, Exfoliation |
1, Exfoliation |
2 |
Eschar |
Eschar, Application site moved* |
Eschar* |
1-Edema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
2-Erythema |
1 |
0 |
0 |
1 |
1 |
1 |
1 |
2 |
1 |
2- Edema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
3- Erythema |
2 |
0 |
Exfoliation |
1 |
1 |
2 |
2, Exfoliation |
2, Exfoliation |
2 |
3- Edema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
2 |
4 – Erythema |
2 |
1 |
1, Exfoliation |
1, Exfoliation |
1, Exfoliation |
2 |
2 |
2 |
2, Exfoliation |
4 – Edema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
5 – Erythema |
1 |
0 |
2, Exfoliation |
2, Exfoliation |
2, Exfoliation |
2 |
Eschar |
2, Application site moved |
1 |
5 – Edema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
6 – Erythema |
1 |
0 |
0 |
1 |
1 |
2 |
2 |
Eschar |
1, Application site moved |
6 – Edema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
7 – Erythema |
0 |
0 |
0 |
0 |
0 |
1 |
2 |
1 |
1, Exfoliation |
7 – Edema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
8 – Erythema |
0 |
0 |
0 |
2 |
2 |
2 |
2, Exfoliation |
2, Exfoliation |
2, Exfoliation |
8 – Edema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
9 – Erythema |
0 |
0 |
0 |
1 |
1 |
2 |
2, Exfoliation |
2, Exfoliation |
2 |
9 – Edema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
10 – Erythema |
2 |
1 |
2, Exfoliation |
1 |
1 |
1 |
2 |
2 |
2 |
10 - Edema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
* Due to technician error, the original induction site was scored instead of the new test site.
Skin Sensitization Challenge Phase
Animal |
24 hrs |
48 hrs |
Induced Animals |
|
|
1 – Erythema |
2 |
1 |
1-Edema |
0 |
0 |
2-Erythema |
2 |
1 |
2- Edema |
0 |
0 |
3- Erythema |
2 |
0 |
3- Edema |
0 |
0 |
4 – Erythema |
2 |
1 |
4 – Edema |
0 |
0 |
5 – Erythema |
3 |
2 |
5 – Edema |
2 |
0 |
6 – Erythema |
3 |
2 |
6 – Edema |
2 |
0 |
7 – Erythema |
2 |
1 |
7 – Edema |
0 |
0 |
8 – Erythema |
2 |
2 |
8 – Edema |
1 |
0 |
9 – Erythema |
3 |
2 |
9 – Edema |
2 |
0 |
10 – Erythema |
4 |
2 |
10 - Edema |
2 |
1 |
Naïve Controls |
|
|
1 – Erythema |
1 |
0 |
1-Edema |
0 |
0 |
2-Erythema |
0 |
0 |
2- Edema |
0 |
0 |
3- Erythema |
0 |
0 |
3- Edema |
0 |
0 |
4 – Erythema |
0 |
0 |
4 – Edema |
0 |
0 |
5 – Erythema |
0 |
0 |
5 – Edema |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance is not sensitizing to the skin.
- Executive summary:
The skin sensitization potential of the test substance was determined in a test using guinea pigs according to the method developed by Buehler. 10 guinea pigs were given 9 dermal induction exposures, and then after two weeks, given a challenge exposure to 0.4 mL of pure test substance. 5 naive control animals were used as a negative control, and a postive control experiment was performed as well. The postive and negative control results were valid. No skin reactions were seen in any animal in the test group during the challenge phase. The test substance is therefore not sensitizing to skin.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.