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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
Toxicity to reproduction
Administrative data
- Endpoint:
- fertility, other
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982-1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study according to accepted scientific standards at time of performance and performed under internal GLP. Well conducted and documented. Reporting conclusive.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Segment I study. Subcutaneous injection of test material for 9 weeks (male animals) or 2 weeks (female animals) before mating and up to day 6 of gestation. Cesarean sections performed on day 18 of gestation. Visceral and skeletal anomalies were examined.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Internal Reliability Assurance
- 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
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CLEA Japan, Inc.
- Age at study initiation: 10 - 12 weeks
- Weight at study initiation: approx. 200 g (male animals), approx. 190 g (female animals)
- Fasting period before study: no
- Housing: plastic cages (individually during gestation)
- Use of restrainers for preventing ingestion (if dermal): no
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2 °C
- Humidity (%): 55 +/- 5 %
- Air changes (per hr): 12 times per hour
- Photoperiod (hrs dark / hrs light): 12 hour interval
Administration / exposure
- Route of administration:
- subcutaneous
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on exposure:
- Test compound was mixed with sterile 0.5% CMC at 5 mL / kg body weight ratio, converted into mg/mL/kg value (based on daily body weight)
injected subcutaneously. - Details on mating procedure:
- - M/F ratio per cage: 1 : 1 ratio
- Length of cohabitation: 1 night
- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of pregnancy
- Further matings after two unsuccessful attempts: no
- After successful mating each pregnant female was caged (how): individual
- Any other deviations from standard protocol: no - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 9 weeks before mating and through mating period (male animals), 2 weeks befor mating up to day 6 of gestation (female animals)
- Frequency of treatment:
- Once daily
- Details on study schedule:
- - F1 parental animals not mated until [...] weeks after selected from the F1 litters: n.a.
- Selection of parents from F1 generation when pups were [...] days of age: n.a.
- Age at mating of the mated animals in the study: [...] weeks: n.a.
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
20 mg/kg
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
50 mg/kg
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
100 mg/kg
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
500 mg/kg
Basis:
nominal conc.
- No. of animals per sex per dose:
- 24 gestating rats in 20 mg/kg group
24 gestating rats in 50 mg/kg group
24 gestating rats in 100 mg/kg group
24 gestating rats in 500 mg/kg group - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Based on available results from a developmental dose-range finder
- Rationale for animal assignment (if not random): random
- Other: - Positive control:
- no positive control
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: day 0, 4, 8, 12, 16 - 21
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): n.a.
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): n.a.
OTHER: - Oestrous cyclicity (parental animals):
- no data
- Sperm parameters (parental animals):
- no data
- Litter observations:
- STANDARDISATION OF LITTERS
- Performed on day 4 postpartum: yes
- If yes, maximum of 8 pups/litter (4/sex/litter as nearly as possible); excess pups were killed and discarded.
PARAMETERS EXAMINED
The following parameters were examined in F1 offspring:
number and sex of pups, stillbirths, live births, postnatal mortality, presence of gross anomalies, weight gain, physical or behavioural abnormalities, feed intake,
GROSS EXAMINATION OF DEAD PUPS:
yes - Postmortem examinations (parental animals):
- SACRIFICE
- Male animals: All surviving animals
GROSS NECROPSY
- Gross necropsy consisted of external and internal examinations
- Statistics:
- yes
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- Male animals from highest dose having received test material subcutaneously for 9 weeks prior to mating due to remarkable inflammatory changes at the application side leading to a poor general health status. However, survived males at this dose level were shown to have reproductive ability.
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
Details on results (P0)
8 male animsls died in the highes dose group (500 mg/kg) mainly due to severe inflammation reactions at the injection side
BODY WEIGHT AND FOOD CONSUMPTION (PARENTAL ANIMALS)
Body weight gain was depressed in the male animals and in females during gestation in the highest dose group (500 mg/kg)
TEST SUBSTANCE INTAKE (PARENTAL ANIMALS)
REPRODUCTIVE FUNCTION: ESTROUS CYCLE (PARENTAL ANIMALS)
REPRODUCTIVE FUNCTION: SPERM MEASURES (PARENTAL ANIMALS)
REPRODUCTIVE PERFORMANCE (PARENTAL ANIMALS)
ORGAN WEIGHTS (PARENTAL ANIMALS)
GROSS PATHOLOGY (PARENTAL ANIMALS)
HISTOPATHOLOGY (PARENTAL ANIMALS)
OTHER FINDINGS (PARENTAL ANIMALS)
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 100 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: overall effects, clinical signs, inflammation at injection side, mortality at highest dose level
- Remarks on result:
- not determinable due to adverse toxic effects at highest dose / concentration tested
Target system / organ toxicity (P0)
- Critical effects observed:
- no
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food efficiency:
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- no effects observed
- Other effects:
- no effects observed
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not examined
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not examined
Details on results (F1)
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- >= 500 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Piroctone olamine is not considered to be reproductive toxic after subcutaneous injection. Maternal toxic effects are confined to local effects at the
injection side in the highest dose group. - Executive summary:
Piroctone olamine was subcutaneously given to groups of 24 male and 24 female rats at daily doses of 0, 20, 50, 100 or 500 mg/kg body weight. Males were administered the test compound for 9 weeks before mating and through the mating period, while the females were treated for 2 weeks before mating up to day 6 of gestation. In the highest dose-group 8 male animals died probably due to remarkable inflammatory changes at the application side leading to a poor general health status. Additionally body weight gain was depressed in both male and female animals of the highest dose group. Copulation was delayed in the 500 mg/kg dosage group. However, the females and survived males at this dose level were shown to have reproductive ability. At each treatment level, fetuses exhibited no changes in any parameters examined at cesarian section. No differences occurred between treated and control animals in the incidences of visceral anomalies, skeletal anomalies and variations, and delayed ossification. Based on the results of this study, no significant reproductive toxicity is attributable to piroctone olamine.
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