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Diss Factsheets
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EC number: 210-288-1 | CAS number: 611-99-4
- 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
Endpoint summary
Administrative data
Description of key information
Information published in the Cosmetic Ingreient Review (CIR) assessment of Benzophenones (1983) confirmed that these substances were tested for potential irritation and sensitization to both guinea pig and human skin, and in general, these ingredients were reported to be nonirritating and nonsensitizing at concentrations higher than those found in cosmetics.
RIPT test data included in the CIR report relating to benzophenone-3 (oxybenzone). Four tests involved a total of 600 humans and the test substance was 3% oxybenzone in sunscreen as detailed in this result. In all of those RIPT tests, only one person out of the test population showed any effect that could be considered due to the substance. It was consluded that this substance did not have a sensitising effect on humans.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Qualifier:
- according to guideline
- Guideline:
- other: Kligman Maximization Procedure.
- Deviations:
- not specified
- Principles of method if other than guideline:
- A 0.05 ml intradermal injection of 5% Benzophenone-3 in corn oil or 50% Benzophenone-3 in aqueous Freund’s Adjuvant was administered to the shaved back of each of ten female albino guinea pigs per solution.
Seven days following injection, a topical booster patch containing 10% Benzophenone-3 in petrolatum was applied for 48 hours.
Two weeks later, a challenge test of 0.1 ml of 2.5% Benzophenone-3 in petrolatum was applied under an occlusive patch to a virgin site for 24 hours. Sites were scored 24 and 48 hours after patch removal. - GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Data from this in-vivo test already existed as having been caried out as part of a cosmetics review in 1983. The data is quite comprehensive and on the basis of the available animal data and clinical human experience, it
is concluded that Benzophenone-1, -3, -4, -5, -9, and -11. are safe for topical application to humans in the present practices of use and concentration in cosmetics. Further non-LLNA testing was not assessed as being necessary - Species:
- guinea pig
- Strain:
- other: Albino
- Sex:
- female
- Route:
- intradermal
- Vehicle:
- corn oil
- Concentration / amount:
- 5%,
- Day(s)/duration:
- 7
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- intradermal
- Vehicle:
- other: freunds adjuvant solution
- Concentration / amount:
- 50%
- Day(s)/duration:
- 7
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No. of animals per dose:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- A 0.05 ml intradermal injection of 5% Benzophenone-3 in corn oil or 50% Benzophenone-3 in aqueous Freund’s Adjuvant was administered to the shaved back of each of ten female albino guinea pigs per solution.
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Nothing specified
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- A 0.05 ml intradermal injection of 5% Benzophenone-3 in corn oil or 50% Benzophenone-3 in aqueous Freund’s Adjuvant was administered to the shaved back of each of ten female albino guinea pigs per solution.
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Nothing specified
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Results of this test indicated that Benzophenone-3 was not a skin sensitizer.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
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.