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EC number: 219-845-3 | CAS number: 2550-11-0
- 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:
- 29 April 1996 to 27 June 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- In-vivo data sufficient therefore no additional testing required.
Test material
- Reference substance name:
- 4,7-dimethyloct-6-en-3-one
- EC Number:
- 219-845-3
- EC Name:
- 4,7-dimethyloct-6-en-3-one
- Cas Number:
- 2550-11-0
- Molecular formula:
- C10H18O
- IUPAC Name:
- 4,7-dimethyloct-6-en-3-one
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Identification: Dimethyl octenone
Description: Colorless liquid
Batch Number: 255476
Purity: 96.3%
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Himalyan spotted
- Sex:
- female
- Details on test animals and environmental conditions:
- Animals were housed individually in cages with standard softwood bedding. Standard pelleted food and water were available ad libitum.
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: ethanol; 1:1 mixture of Freund's Complete Adjuvant and physiological saline; unchanged (no vehicle)
- Concentration / amount:
- 5% for intradermal injections and 100% for epidermal applications
- Day(s)/duration:
- Day one for intradermal injections; Day 8 for epidermal applications for 48 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol
- Concentration / amount:
- 15%
- Day(s)/duration:
- 1 day
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20 treated animals; 10 control animals
- Details on study design:
- A Magnusson-Kligman guinea pig maximization test was conducted on 20 female guinea pigs. The animals were induced intradermally at 5%, then epidermally at 100% one week later. After two weeks, the animals were challenged with 15% Dimethyl Octenone. The vehicle was ethanol.
Dimethyl Octenone did not induce skin sensitization in any of the guinea pigs. - Challenge controls:
- For validation of sensitivity of the Maximization - Test of B. Magnusson and A.M. Kligman (1969) as well as the sensitivity of the test system used, a known moderate sensitizer was selected as a positive control. This was performed in accordance with the recommendation of the OECD for testing of chemicals number 406 "Skin Sensitization Test", adopted by the council on July 17, 1992.
- Positive control substance(s):
- yes
- Remarks:
- 2-Mercaptobenzothiazole and alpha-hexylcinnamaldehyde
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 15%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No toxic symptoms, no deaths
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 15%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No toxic symptoms, no deaths
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 15%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 15%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study 0% of the animals of the test group were observed with positive skin reactions after treatment with a non-irritant test substance concentration of 15% in ethanol. No skin reactions were observed in the control group.
- Executive summary:
The purpose of this skin sensitizing study was to assess the possible allergenic potential of DIMETHYL OCTENONE to albino guinea pigs. The maximization-test of B. Magnusson and A.M. Kligman (1969) was used. Twenty female animals of the test group were induced intradermally once in the first week and epidermally once in the second week with DIMETHYL OCTENONE at 5% in ethanol and 100% (undiluted), respectively.
Two weeks after the epidermal induction application the animals were challenged with the vehicle ethanol and the same test substance used for induction at the highest non-irritating concentration of 15% in ethanol.
The animals of the control group were induced with ethanol only and treated once at challenge with ethanol and DIMETHYL OCTENONE at 15% in ethanol.
No toxic symptoms were evident in the guinea pigs of the control group or test group.
No deaths occurred.
Therefore, the test article DIMETHYL OCTENONE applied at a concentration of 15% in ethanol is considered to be a non-sensitizer when used under the described test conditions.
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