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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
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Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was conducted prior to GLP and although it was not done according to any recognised testing guideline it followed scientifically accepted standards at that time. Based hereupon it does meet many of the requirements of OECD Test Guideline 410. The study itself is also well conducted, well documented and scientifically acceptable.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)
- Deviations:
- yes
- Remarks:
- subcutaneous injection
- Principles of method if other than guideline:
- Test item was subcutaneously injected
- GLP compliance:
- no
- Limit test:
- no
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
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- other: subcutaneous injection
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 5 weeks + 2 weeks recovery
- Frequency of treatment:
- once daily
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
100 mg/kg
Basis:
nominal per unit body weight
- Remarks:
- Doses / Concentrations:
500 mg/kg
Basis:
nominal per unit body weight
- Remarks:
- Doses / Concentrations:
2000 mg/kg
Basis:
nominal per unit body weight
- No. of animals per sex per dose:
- 15 male / 15 female animals per group
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- - Dose selection rationale: expert judgement
- Rationale for animal assignment (if not random): random
- Rationale for selecting satellite groups: no satellite group
- Post-exposure recovery period in satellite groups: 2-week recovery group
- Section schedule rationale (if not random): random
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes
DERMAL IRRITATION (if dermal study): No data (subcutaneous injection)
BODY WEIGHT: Yes
- Time schedule for examinations: daily
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION: No data
OPHTHALMOSCOPIC EXAMINATION: Yes
HAEMATOLOGY: Yes
CLINICAL CHEMISTRY: Yes
URINALYSIS: Yes
NEUROBEHAVIOURAL EXAMINATION: No data
OTHER: - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Dermal irritation:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- effects observed, treatment-related
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY
General symptoms included loss of hair gloss and piloerection. One male of the 500 mg and two males of the 2000 mg/kg group died. Abnormalities in general health or deaths were not observed in the 100 mg/kg group.
BODY WEIGHT AND WEIGHT GAIN
Body weight gain was suppressed in males and females of the 500 and 2000 mg/kg group.
FOOD CONSUMPTION
Not significantly affected
FOOD EFFICIENCY
Not significantly affected
WATER CONSUMPTION
Not significantly affected
OPHTHALMOSCOPIC EXAMINATION
No abnormalities
HAEMATOLOGY
In both sexes of the 500 and 2000 mg/kg group slight anemia, low lymphocyte count, high segmented neutrophil count and in females of the 500
and 2000 mg/kg group high leucocyte count
CLINICAL CHEMISTRY
In the 2000 mg/kg group low values of total protein and A/G ratio as well as elevations of urea-nitrogen, cholesterol and alkaline phosphatase
activity
URINALYSIS
In the 500 and 2000 mg/kg group elevated values of Na+ in both sexes
NEUROBEHAVIOUR
No data
ORGAN WEIGHTS
Slight changes in absolute and relative organ weights in 500 and 2000 mg/kg group but no histopathological correlate
GROSS PATHOLOGY
Residue of test compound found at dorsal injection sites of all dose groups. Marked inflammatory changes at injection sites of the 500 and 2000 mg/kg dose group.
HISTOPATHOLOGY: NON-NEOPLASTIC
No abnormalities
HISTOPATHOLOGY: NEOPLASTIC (if applicable)
No abnormalities
HISTORICAL CONTROL DATA (if applicable)
No data
OTHER FINDINGS
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- >= 100 - <= 500 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: overall effects
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- After repeated subcutaneous injection of Octopirox to rats , the no observed effect level (NOEL) was considered to be 100 mg/kg body weight.
- Executive summary:
Piroctone olamine was administered to groups of 15 male and 15 female Sprague-Dawley rats by subcutaneous injection at dose levels of 0, 100, 500 or 2000 mg/kg body weight. The animals were treated once daily for a period of 5 weeks. Following the treatment sutviving animals were subjected to a 2 week recovery experiment. One male of the 500 mg/kg group and two males of the 2000 mg/kg group died during the treatment period. Neither abnormalities in general symptoms nor deaths were observed in the 100 mg/kg group. Changes in general health condition were noticed in the 500 mg/kg and 2000 mg/kg dose group and included loss of hair gloss, hard hairs, piloerection and depressed body weight gain in both males and females. Haematological findings included anemia, low lymphocyte count and high segmented neutrophil count in both sexes of the 500 mg/kg and 2000 mg/kg dose group. In addition, high leucocyte count in females of the medium and high dose groups could be noticed. Serum biochemistry revealed low total protein and high urea nitrogen values in the 500 mg/kg dose group and, only in females of this group, high cholesterol values. Changes in the 2000 mg/kg group included low values of total protein and in the albumin : globulin ratio as well as elevations of urea-nitrogen, cholesterol and alkaline phosphatase values. Urinalysis indicated increased values of Na+ in both sexes of the 500 mg/kg and 2000 mg/kg group. The ophthalmologic examinations revealed no abnormalities in any of the treatment groups. Although changes in absolute and relative organ weights were observed in both sexes of the 500 mg/kg and 2000 mg/kg group, no histopathological abnormalities were detected. At necropsy, the residue of the test compound was found at the dorsal injection sites of all dosage groups. In addition, marked inflammatory changes at the injection sites were seen at the gross and histopathological examinations of the animals treated with 500 mg/kg and 2000 mg/kg body weight. During the recovery period, indications of a reversible nature of the mentioned changes were found. Especially those in general symptoms, body weight, haematology and organ weights showed favorable recoveries. The no observed effect level (NOEL) after repeated subcutaneous injection to rats was placed at 100 mg/kg body weight.
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