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Diss Factsheets
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EC number: 204-260-8 | CAS number: 118-56-9
- 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
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2005
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: provides some human information, test products containing 10%-15% test article
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Approved study protocol and standard operating procedures by the New England Institutional Review Board (NEIRB) 2005
- Deviations:
- not applicable
- GLP compliance:
- yes
Test material
- Reference substance name:
- Homosalate
- EC Number:
- 204-260-8
- EC Name:
- Homosalate
- Cas Number:
- 118-56-9
- Molecular formula:
- C16H22O3
- IUPAC Name:
- 3,3,5-trimethylcyclohexyl salicylate
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- confirmed, but no further information available
- Subjects:
- male and female, 236 volunteers started the study and 209 completed it
- Route of administration:
- dermal
- Details on study design:
- A repeated insult patch test (RIPT) according to the approved NEIRB study protocol was performed with 3 different sunscreens containing 10% or 15% homosalate among other substances on a panel of 236 male and female volunteers under GLP conditions.
Induction period: During the induction phase, approximately 0.2 g of the test material was applied to the dry wiped skin on the left side of the back of each volunteer. The webril/adhesive patch was semi-occlusively covered and remained on the skin for 24 hours. Thereafter, the patches were remo ved and the skin was scored. The patch removal was followed by a rest period of 24 hours for workdays or 48 hours for weekend. A series of 9 induction patches was completed over a period of 3 weeks.
Rest period: The last induction patching was followed by a rest period of two weeks with no application.
Challenge period: After the rest period, a webril/adhesive patch was applied with 0.2 g of the test material and fixed semi-occlusively on the virgin, right side of the back of each volunteer for 24 hours. After removal, the application sites were scored at about 24, 48, 72 and 96 hours post-patching. The complete test was conducted under the supervision of a Board-Certified Dermatologist, which participated also in the scorings of the volunteers.
Results and discussion
- Results of examinations:
- 209 volunteers completed the study and 27 discontinued but not due to test material reaction. During the induction phase each one volunteers showed a transient and negligible erythema after application of sunscreen SPF-30 (a) or 45 (b) on single readings, while no skin findings were observed on the tested skin areas of any of the volunteers at any time challenge tested with these materials. With sunscreen SPF-30 (c), no skin finding was noted during induction in any of the volunteers, while one subject showed a low level reaction on the 48 hour reading but not at 24, 72 or 96 hours readings.
Applicant's summary and conclusion
- Conclusions:
- With none of the tested sunscreen products containing 10% or 15% test article there was an indication for an irritative or sensitizing potential under the conditions of the RIPT study in male and female Human volunteers. Thus, the substance was considered not sensitising for humans when applied at 10-15%.
- Executive summary:
These reports, which presented in SCCP 1086/07, were performed in 2005 in compliance with GLP regulations according to approved study protocol and standard operating procedures by the New England Institutional Review Board (NEIRB) 2005.
209 volunteers completed the study and 27 discontinued but not due to test material reaction. During the induction phase each one volunteers showed a transient and negligible erythema after application of sunscreen SPF-30 (a) or 45 (b) on single readings, while no skin findings were observed on the tested skin areas of any of the volunteers at any time challenge tested with these materials. With sunscreen SPF-30 (c), no skin finding was noted during induction in any of the volunteers, while one subject showed a low level reaction on the 48 hour reading but not at 24, 72 or 96 hours readings. Based on these results, no potentical for dermal irritation and sensitisation to human was associated with test article (10%-15%).
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