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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1979
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was conducted prior to establishment of OECD testing guidelines but followed scientifically accepted standards. The study is well conducted and well documented. As it fullfills a lot of requirements of todays testing guidelines it is acceptable for evaluation purposes.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Principles of method if other than guideline:
- Reproductive toxicity study (segment II) with test compound administration to rabbits during the sensitive phase of organogenesis (gestation days 7 to 19)
- GLP compliance:
- yes (incl. QA statement)
- 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:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoe: HIMK (SPF Wiga)
- Age at study initiation: 6 to 7 month
- Weight at study initiation: 2579 +/- 162 g
- Fasting period before study: no
- Housing: individually
- Diet (e.g. ad libitum): Erka Z 6000, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23°C
- Humidity (%): 55 - 65 %
- Air changes (per hr): 16 - 20 times per hour
- Photoperiod (hrs dark / hrs light): 12 hour interval
IN-LIFE DATES: From: October 23, 1978 To: January 2, 1979
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: starch mucilar
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
Octopirox was suspended in starch mucilage (20 g starch per liter redistilled water). Suspensions were prepared fresh each day.
DIET PREPARATION
- Rate of preparation of diet (frequency):
- Mixing appropriate amounts with (Type of food):
- Storage temperature of food:
VEHICLE
- Justification for use and choice of vehicle (if other than water): recommended and accepted vehicle - Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1 : 1
- Length of cohabitation: over night
- Further matings after two unsuccessful attempts: no
- Verification of same strain and source of both sexes: yes
- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of pregnancy - Duration of treatment / exposure:
- exposure from day 7 to day 19
- Frequency of treatment:
- once daily
- Duration of test:
- until day 29 of pregnancy
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day
- Dose / conc.:
- 16 mg/kg bw/day
- Dose / conc.:
- 32 mg/kg bw/day
- Dose / conc.:
- 63 mg/kg bw/day
- No. of animals per sex per dose:
- 15 pregnant females per group
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: based on preceding exploratory study
- Rationale for animal assignment (if not random): random
- Other:
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: once a week
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes, continually
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 29
- Organs examined: heart, liver, kidneys, spleen
OTHER: - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes / No / No data
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes
- Other: placentae, live and dead fetuses - Fetal examinations:
- - External examinations: Yes, all per litter
- Soft tissue examinations: Yes, half per litter
- Skeletal examinations: Yes, half per litter
- Head examinations: No data
- 24 hour viability check - Statistics:
- Dunnett`s simultaneous comparison; Nemenyi`s many-one version of H-test; Goodman`s simultaneous comparison; Wilcoxon comparison;
Student`s t-test
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- no effects observed
- Mortality:
- 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
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- no effects observed
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- no effects observed
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): no effects observed - Changes in number of pregnant:
- no effects observed
- Other effects:
- no effects observed
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Effect levels (maternal animals)
- Dose descriptor:
- NOEL
- Effect level:
- > 63 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Results (fetuses)
- Fetal body weight changes:
- not examined
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): not examined - Reduction in number of live offspring:
- not examined
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- not examined
- Changes in postnatal survival:
- not examined
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- no effects observed
- Other effects:
- no effects observed
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Effect levels (fetuses)
- Dose descriptor:
- NOEL
- Effect level:
- > 63 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: teratogenicity
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Fetal abnormalities
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Developmental effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Based on the results of this study Piroctone olamine does not elicite maternal toxicity and is not embryotoxic and not teratogenic.
- Executive summary:
Piroctone olamine was investigated for embryotoxic and/or developmental (teratogenic) toxicity using groups of 15 pregnant female rabbits. They were administered Piroctone olamine orally by gavage once daily on days 7 - 19 of gestation at dose-levels of 0, 16, 32 or 63 mg/kg body weight. On day 29 of pregnancy the dams were killed and delivered by cesarean section. On opening the uterus, live and dead fetuses, fetal resoprtion sites, placentae, and corpora lutea on the ovaries were counted and macroscopically assessed. Body weight and crown-rump length of the fetuses, the diameter of the conceptuses under resorption and placental weight were determiend. The sex of the fetuses was determined at autopsy. All fetuses underwent gross pathological evaluation. About half of the fetuses in each litter were subjected for examination of visceral and the other half of skeletal malformations. The results showed that repeated administration of Piroctone olamine in the sensitive phase of organogenesis caused no impairment of general health status of the dams and no disturbances of intrauterine development of the fetuses. The examinations of the fetuses for developmental status, externally acertainable abnormalities, visceral and skeletal malformations, and a 24 -hour viability test suggested no embryotoxic and teratogenic action of Piroctone olamine.
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