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EC number: 222-225-5 | CAS number: 3391-83-1
- 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:
- 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Version / remarks:
- Method of Magnusson and Kligman
- Principles of method if other than guideline:
- Mehtod of Magnusson and Kligman "Allergic Contact Dermatitis in Guinea Pigs", Ed. Ch.C. Thomas, Springfield, Illinois, USA (1970).
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- This in vivo GPMT fulfills the skin sensitisation endpoint, follows a well reviewed and accepted guidance at the time, is well documented and the results are very clearly negative.
Test material
- Reference substance name:
- 11-oxahexadecan-16-olide
- EC Number:
- 222-225-5
- EC Name:
- 11-oxahexadecan-16-olide
- Cas Number:
- 3391-83-1
- Molecular formula:
- C15H28O3
- IUPAC Name:
- 1,7-dioxacycloheptadecan-8-one
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Musk R1, T 02437, No. 148983.
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Albino SPF
- Remarks:
- Acceptable strain of guinea pig used routinely at the time of the study.
- Sex:
- male
- Details on test animals and environmental conditions:
- Acclimatisation: 2 days.
Room temperature: 23-25'C.
Relative humidity: 40-70%.
Day/Light cycle: 12 hours each.
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- 2% Musk R1 as this was the lowest irritating dose level.
- Day(s)/duration:
- 1 day, 6 injections
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- 10%
- Day(s)/duration:
- 48 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- Control: 5 animals.
Musk R1: 10 animals. - Details on study design:
- Intradermal injections of the test substance were given both after mixing with Freunds adjuvant and also after diluting with propylene glycol (PG),. An area of 4x6 cm of the shoulder region was shaved with electric clippers. Then within a few minutes the 6 intradermal injections were given in an area of 2x4 cm in 2 rows of 3.
Induction: Control animals:
1). 2 injections with Adjuvant.
2). 2 injections with PG.
3). 2 injections with PG + Adjuvant (1:1).
Induction: Test Substance animals:
1). 2 injections of 0.05 ml Freund's Adjuvant.
2). 2 injections of 0.05 ml of a 2% Musk R1 dilution in PG.
3). 2 injections of 0.05 ml of a 2% Musk R1 dilution in PG and Adjuvant (1:1).
One week later:
The same area was shaved again. A patch of 2x4 cm Whatman 3mm filter paper was spread with a 10% dilution of Musk R1 in vaseline and then placed on the shaved skin covered by paraplast which was kept in place by adhesive bandage. This in turn was firmly secured bu self sticking tape and left in place for 48 hours.
Challenge:
The animals were challenged at day 14 after the topical induction on the right flank of which an area of 5x5 cm was shaved. For this treatment Musk R1 was mixed with vaseline. A concentration of 10% (w/w), which proved to be non-irritationg in a preliminary test, was used for the challenge.
A small amount of the 10% mixture was applied to the shaved area of each animal and gently massaged in with a glass rode for 30 seconds. The material was applied to an area of 2x2 cm and was covered by a patch of 2x2 cm Whatman 3mm filter paper and paraplast, kept in place by adhesive bandage and firmly secured by self sticking tape. At the same time the the challenge treatment was applied to the 5 control animals.
Skin readings were made 24 hours after the challenge treatment in both control and test animals.
Skin reactions were judged by the method of Draize, as decribed in J. Pharmacol. 82 (1944) 377-390. - Challenge controls:
- At the same time the the challenge treatment was applied to the 5 control animals.
- Positive control substance(s):
- no
- Remarks:
- No required for this assessment as not ethitically appropriate.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- Induction phase: No Clinical observations. Challenge phase: No Clinical observations.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Induction phase: Slight edema and abscesses. Challenge phase: No Clinical observations.
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The 10% dilution of Musk R1 in vaseline induced neither erythema nor edema upon topical application in the induction phase of the study.
The challenge dose of 10% provoked no positive reactions in the 10 test substance animals. At the same time none of the 5 control animals reacted positively either. - Executive summary:
On the basic of the results obtained , the test substance Musk R1 exhibited no sensitisation properties according to the classification of Magnusson and Kligman (1970).
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