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Diss Factsheets
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EC number: 403-610-9 | CAS number: 122795-41-9
- 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
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Endpoint summary
Administrative data
Description of key information
The sensitising potential of the test substance was tested according to OECD TG 406, GPMT test. Based upon the observations made in the Delayed Contact Hypersensitivity Study Neoproxen tested at a 2.0% concentration did not cause delayed contact hypersensitivity in guinea pigs.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The sensitising potential of the test substance was tested according to OECD TG 406, GPMT test. Based upon the results of the dose-range-finding studies the dose chosen for induction, challenge and rechallenge was 2.0%.
No responses were observed in the naive group at 24 or 48 hours after challenge. Two positive responses were observed at 24 hours and three positive responses were observed at 48 hours after challenge in the experimental animals receiving the test article at a 2.0% concentration.
The experimental animals were rechallenged seven days after challenge, with the test article at a 2.0% concentration. Four animals from the negative control group (2 males and 2 females) served as naive control animals for the rechallenge. Responses were observed in the naive control animals at 24 and 48 hours after rechallenge, being indicative for irritation. No positive responses were observed in the experimental animals at 24 or 48 hours after rechallenge.
Based upon the observations made in the Delayed Contact Hypersensitivity Study, test article, Neoproxen induced, challenged and rechallenged at a 2.0% concentration did not cause delayed contact hypersensitivity in guinea pigs.
It can be argued that the concentration (2%) used for induction and challenge is quite low, though some slight irritation was observed during rechallange in the naive control group animals. Neoproxen as such does not contain skin sensitizing structural alerts as can be seen when running the OECD Toolbox and/or Derek Nexus. This further supports the non-skin sensitizing potential.
Justification for classification or non-classification
The substance does not need to be classified for skin sensitisation according to EU CLP (EC No. 1272/2008 and its amendments).
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.
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