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EC number: 261-665-2 | CAS number: 59219-71-5
- 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
Direct observations: clinical cases, poisoning incidents and other
Administrative data
- Endpoint:
- direct observations: clinical cases, poisoning incidents and other
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Documentation is insufficient for assessment. Few details on the study protocol are given.
Data source
Reference
- Reference Type:
- publication
- Title:
- New cosmetic allergens: isononyl isononanoate and trioleyl phosphate
- Author:
- Goossens, A. et al.
- Year:
- 2 008
- Bibliographic source:
- Contact Dermatitis, 2008; 59: 320-321
Materials and methods
- Study type:
- clinical case study
- Endpoint addressed:
- other: allergenic contact dermatitis
- Principles of method if other than guideline:
- A woman with a history of allergic contact dermatitis reacted to application of a lipstick. Patch testing was performed according to International Contact Dermatitis Research Group criteria, using the ingredients in the lipstick. The skin sensitisation score was assessed on day 2 and 4 after patch testing. Volunteers were patch tested with the substances that the woman reacted to, as a negative control.
- GLP compliance:
- no
Test material
- Reference substance name:
- 3,5,5-trimethylhexyl 3,5,5-trimethylhexanoate
- EC Number:
- 261-665-2
- EC Name:
- 3,5,5-trimethylhexyl 3,5,5-trimethylhexanoate
- Cas Number:
- 59219-71-5
- Molecular formula:
- C18H36O2
- IUPAC Name:
- 3,5,5-trimethylhexyl 3,5,5-trimethylhexanoate
- Details on test material:
- - Name of test material (as cited in study report): isononyl isonoanoate
- Analytical purity: no data
Constituent 1
Method
- Type of population:
- other: case report
- Subjects:
- - Number of subjects exposed: 1 (case report); 20 (control subjects)
- Sex: female (case report)
- Age: 40 (case report) - Ethical approval:
- not applicable
- Route of exposure:
- dermal
- Reason of exposure:
- intentional
- Exposure assessment:
- not specified
- Details on exposure:
- A 40-year old non-atopic woman with a history of reaction to an 'anticellulite' cream (Roc Retinol Body Contouring Triple Action Creme, Johnson & Johnson, Issy-les-Moulineaux, France) presented in 2002 with contact chelitis following application of Rouge Novalip lipstick (La Roche Posay, France). Patch testing with the European baseline series (Trolab: Hermal, Reinbek, Germany) and a cosmetics series were performed with negative response. Patch testing with Rouge Novalip (two colours) and the Roc Retinol Body Contouring Triple Action Creme caused a positive result. Details of the patch test method was not provided.
In September 2007 the patient presented with severe allergic contact dermatitis on the eyelids following the application of lipstick to the eyelids (Rouge Novalip, La Roche-Posay, France). Patch testing with the individual ingredients of the lipstick was conducted; resulting in reactions to isononyl isononanoate, trioleyl phosphate and oleyl erucate. No details of the study protocol were provided.
Additional patch testing with the lipstick ingredients was performed in November 2007. Van der Bend patch test chambers were attached with Micropore and fixed in place with Mefix adhesive tape. The results were scored according to the International Contact Dermatitis Research Group criteria on Day 2, 4 and 7. The results showed strong vesicular positive reactions to all tested ethanolic dilutions of isononanoate tested on the forearm, from20% (which is the actual use concentration in the product) to 1%. On Day 7, the patient developed severe oedema of the whole test area. The 5% preparation in petrolatum gave a negative result. There was a positive reaction to trioleyl phosphate 1% and 5% in petrolatum. The positive result to oleyl erucate (20% in petrolatum) observed in September 2007 could not be reproduced.
In June 2008, patch tests using the same methods were performed with analogues, to assess the possiblility of cross-reactions. No positive reactions were observed with cetearyl ethylhexanoate (1, 2.5, 5, 10% in ethanol), cetearyl isononanoate (1, 2.5, 5, 10% in pet.), cetyl phosphate (1, 2.5, 5, 10% in pet.), diisopropyl adipate (20% in ethanol), isodecyl neopentanoate (1, 2.5, 5, 10% in ethanol), octyldodecyl neopentanoate (1, 2.5, 5, 10% in ethanol), oleyl erucate (20% on pet.), and stearyl ethylhexanoate and cetyl hexanoate (5% in pet.). Subsequent testing with isononyl isononanoate (5% ethanol) and trioleyl phosphate (1% in pet.) in 20 control subjects gave a negative result.
Results and discussion
- Clinical signs:
- Results of patch testing:
- September 2007: Positive reactions to isononyl isononanoate, trioleyl phosphate (Day 7 only) and oleyl erucate (Day 7 only) were reported.
- November 2007: The results showed strong vesicular positive reactions to all tested ethanolic dilutions of isononanoate tested on the forearm, from20% (which is the actual use concentration in the product) to 1%. On day 7, the patient developed severe oedema of the whole test area. The 5% preparation in petrolatum gave a negative result. There was a positive reaction to trioleyl phosphate 1% and 5% in petrolatum. The positive result to oleyl erucate (20% in petrolatum) observed in September 2007 could not be reproduced.
- June 2008: No positive reactions were observed with cetearyl ethylhexanoate (1, 2.5, 5, 10% in ethanol), cetearyl isononanoate (1, 2.5, 5, 10% in pet.), cetyl phosphate (1, 2.5, 5, 10% in pet.), diisopropyl adipate (20% in ethanol), isodecyl neopentanoate (1, 2.5, 5, 10% in ethanol), octyldodecyl neopentanoate (1, 2.5, 5, 10% in ethanol), oleyl erucate (20% on pet.), and stearyl ethylhexanoate and cetyl hexanoate (5% in pet.). Subsequent testing with isononyl isononanoate (5% ethanol) and trioleyl phosphate (1% in pet.) in 20 control subjects gave a negative result.
Applicant's summary and conclusion
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