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Diss Factsheets
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EC number: 266-885-2 | CAS number: 67674-46-8
- 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
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
- Study period:
- 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Principles of method if other than guideline:
- Open epicutaneous test
- GLP compliance:
- no
- Remarks:
- study pre-dates introduction of GLP
- Type of study:
- open epicutaneous test
- Justification for non-LLNA method:
- LLNA no available at time of testing
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): LRG 1393 = Methyl pamplemousse
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data
- Route:
- epicutaneous, open
- Vehicle:
- other: ethanol
- Concentration / amount:
- Main test:
- Induction phase: 100, 30, 10 and 3 % - Route:
- epicutaneous, open
- Vehicle:
- other: ethanol
- Concentration / amount:
- Main Test
- Challenge phase: Minimal irritating and some lower primary non-irritating concentrations - No. of animals per dose:
- 6 animals
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 21
- Test groups: Open epicutaneous application of 0.1 mL of each test concentration (100, 30, 10, and 3 %)
- Control group: No treatment or topical (uncovered) application of 0.1 mL of vehicle (ethanol)
- Site: Clipped flank skin (8 cm2)
- Frequency of applications: Daily for 3 weeks or 5 times weekly for 4 weeks, usually on the same skin sites. When very strong skin reactions were provoked, the application sites were changed.
- Duration: Days 0-20
- Evaluation: Dermal reactions were recorded at 24 h after each application or at the end of each week and the minimal irritating and the maximal non-irritating concentrations were determined by an all-or-none criterion.
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: Days 21 and 35
- Test and control groups: Open epicutaneous application of 0.025 mL of minimal irritating and some lower primary non-irritating concentrations of the test material
- Site: Contralateral flank (2 cm2)
- Evaluation (h after challenge): 24, 48 and/or 72 h - Challenge controls:
- Open epicutaneous application of 0.025 mL of minimal irritating and some lower primary non-irritating concentrations of the test material was performed on control animals during challenge phase.
- Positive control substance(s):
- not specified
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, Methyl pamplemousse was found to be a non-sensitiser to skin of guinea pigs in an open epicutaneous test (OET).
- Executive summary:
In an open epicutaneous test (OET), groups of guinea pigs were topically (uncovered) induced with 0.1 mL of Methyl pamplemousse at doses of 100, 30, 10, and 3 % diluted in ethanol and applied on clipped flank skin (8 cm2), daily for 3 weeks or 5 times weekly for 4 weeks, usually on the same skin sites. The application sites were changed if very strong skin reactions were provoked. At least 6 animals were used in each treatment group and 10 animals in control group. On Days 21 and 35, an open epicutaneous challenge application of 0.025 mL of all tested concentrations of the test material was performed on the contralateral flank (2 cm2) of the animals and the dermal reactions were recorded after 24, 48 and/or 72 h.
Under the test conditions, Methyl pamplemousse was found to be a non-sensitiser to skin of guinea pigs in an open epicutaneous test (OET).
Reference
No positive reaction was observed after challenge exposure.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
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.
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