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EC number: 272-574-2 | CAS number: 68890-66-4
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No OECD Guideline study but according to accepted scientific standards at time of performance
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- not required at time of testing
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The LLNA was not available at time of study implementation. Existing data from Buehler study scientifically adequate.
Test material
- Reference substance name:
- Octopirox
- IUPAC Name:
- Octopirox
- Reference substance name:
- Piroctone olamine
- IUPAC Name:
- Piroctone olamine
- Reference substance name:
- 1-hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)pyridin-2(1H)-one, compound with 2-aminoethanol (1:1)
- EC Number:
- 272-574-2
- EC Name:
- 1-hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)pyridin-2(1H)-one, compound with 2-aminoethanol (1:1)
- Cas Number:
- 68890-66-4
- Molecular formula:
- C14H23NO2.C2H7NO
- IUPAC Name:
- 1-hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)pyridin-2(1H)-one, compound with 2-aminoethanol (1:1)
- Reference substance name:
- 1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)-2-pyridone, 2-aminoethanol salt
- IUPAC Name:
- 1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)-2-pyridone, 2-aminoethanol salt
Constituent 1
Constituent 2
Constituent 3
Constituent 4
In vitro test system
- Details on the study design:
- No in vitro test system available at time of study implementation. Available data from Buehler study scientifically adequate.
In chemico test system
- Details on the study design:
- No in chemico test system available at time of study implementation. Available data from Buehler study scientifically adequate.
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- initial body weights 300 - 400 g
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 40 %
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 40 %
- No. of animals per dose:
- 10
- Details on study design:
- RANGE FINDING TESTS: Yes
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 9
- Exposure period: 3 weeks
- Test groups: 1
- Control group: 1
- Site: back skin
- Frequency of applications: 3 per week
- Duration: 6 hours
- Concentrations: 40 %
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Exposure period: 6 hours
- Test groups: 1
- Control group: 1
- Concentrations: 40 %
- Evaluation (hr after challenge): 24, 48 - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 40%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 40%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 40%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 40%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Octopirox is not a skin sensitiser in the Buehler test
- Executive summary:
Possible skin sensitizing properties of Octopirox were evaluated in Pirbright White guinea pigs using the method of Buehler. Since test concentrations of 40% were tolerated by the guinea pigs without signs of irritation and higher concentrations were too viscous for application, induction exposure and challenge treatment were performed with the 40% concentration of the test substance. For induction exposure 0.5 mL of the 40% dilution was percutaneously applied 9 times in 3 weeks to the intact dorsal skin of 10 male guinea pigs in an occlusive patch test. Exposure was 6 hours on the days of treatment. After the last application, the animals remained untreated for 14 days. Subsequent to this rest period, challenge treatment was carried out by application of 0.5 mL of the 40% dilution under an occlusive patch for 6 hours. During the induction phase marked signs of irritation occurred which, however, were completely reversible within the recovery period. Challenge treatment with 0.5 mL of the 40% dilution caused no signs of irritation in any guinea pig. In addition, the 5 non-sensitized control animals also showed no dermal reactions following challenge treatment. Thus, testing for dermal sensitization with Octopirox in the guinea pig caused no hypersensitive reactions. Octopirox is not regarded to be a skin sensitizer.
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