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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: other studies
Administrative data
- Endpoint:
- toxicity to reproduction: other studies
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted prior to established GLP principles and existing OECD test guidelines but was performed according to accepted scientific standards. The study is well conducted and documented. It is acceptable for evaluation purposes.
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:
- Peri- / Postnatal Developmental Study (Reproductive Toxicity Segment III Study). Administration of test compound during the last stage of gestation and the period of lactation to evaluate the effects on neonatal growth.
- GLP compliance:
- no
- Type of method:
- in vivo
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:
- 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: approximately 185 g
- Fasting period before study: no
- Housing: individual
- 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: 7 days
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:
- PREPARATION OF DOSING SOLUTIONS:
Daily preparation of suspensions in 0.5 % CMC at appropriate concentrations
VEHICLE
- Justification for use and choice of vehicle (if other than water): CMC is a recommended and accepted vehicle - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- During last third of gestation and the perio of lactation
- Frequency of treatment:
- once per day
- Duration of test:
- until 21st day after delivery
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0 mg/kg bw
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
20 mg/kg bw
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
100 mg/kg bw
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
500 mg/kg bw
Basis:
nominal conc.
- No. of animals per sex per dose:
- 22 females (control group), 23 females (low dose group), 24 females (mid dose group), 24 females (high dose group)
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Daily subcutaneous administration of Piroctone olamine to female rats during gestation and the period of lactation (gestation day 17 up to 21st day
after delivery) - Statistics:
- yes
Results and discussion
Effect levels
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- >= 500 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: peri- / postnatal development of offspring, overall effects, reproductive parameters
- Dose descriptor:
- NOAEL
- Effect level:
- >= 500 mg/kg bw/day (nominal)
- Sex:
- female
- Basis for effect level:
- other: overall effects of dams
Observed effects
Applicant's summary and conclusion
- Conclusions:
- Piroctone olamine has no effects on the peri- / postnatal development in rats
- Executive summary:
Piroctone was subcutaneously administered daily to female rats at daily doses of 0, 20, 100 or 500 mg/kg body weight during the last third of gestation and the period of lactation (from day 17 of gestation until day 21 after delivery) to investigate potential effects on the growth of neonatals. Body weight gain of the dams of the highest dose-group was slightly but statistically not significantly depressed. No effects on body weights were observed during lactation. Food consumption decreased in each treatment-group at the end of pregnancy, but no changes were observed during lactation. No changes attributable to treatment occurred in the weights of organs examined (heart, lung, liver, kidneys, adrenals). Regarding the offspring, no treatment related abnormalities were noticed in the following at birth and during postnatal development: various parameters at birth, general differentiation, functions, open field behaviour and learning ability. Postnatal development (opening of ear auricles, emergence of abdominal hair, eruption of upper incisors, opening of eyelids, descent of testis, opening of vagina). No changes attributable to the treatment were observed in the skeletons. Examinations of the F1 offspring for their fertility revealed no abnormalities. Various maternal and fetal parameters examined at cesarean section were unaffected. In summary, subcutaneous administration of Piroctone olamine during the last third of gestation including the period of lactation had no significant influence on the peri- / postnatal development in rats.
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