Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No guideline study, no GLP. Results documented with limitations but acceptable for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: FDA, Vol. 37, No. 38, 1972
- Deviations:
- not specified
- GLP compliance:
- no
- Remarks:
- not required at time of testing
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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- no details given
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 mg
- Concentration (if solution): undiluted product
no vehicle was used. Substance was applied as it is. - Duration of treatment / exposure:
- group 1: 5min.
group 2: 24 h - Observation period (in vivo):
- 1, 24, 48, 72 h
7, 14, 21 d - Number of animals or in vitro replicates:
- group 1: 5
group 2: 3 - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, 2min with 300 ml water
- Time after start of exposure:
group 1: 5 min post applicationem (5 animals)
group 2: 24 hrs post applicationem (3 animals)
SCORING SYSTEM:
cornea: 0 - 4
iris: 0 - 2
conjunctiva: a) redness 0 - 3; b) swelling 0 - 4
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
- 0.1 mL of a 0.01 % fluorescein solution was used to detect damages to the cornea via a UV-lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24h, 48h, 72h, 7d, 14d
- Score:
- > 1 - <= 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24h, 48h, 72h, 7d, 14d
- Score:
- > 1 - <= 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24h, 48h, 72h, 7d, 14d
- Score:
- > 1 - <= 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24h, 48h, 72h, 7d, 14d
- Score:
- > 1 - <= 4
- Max. score:
- 4
- Reversibility:
- not reversible
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- The product caused severe eye-damage of the treated animals. According to the FDA-standards the product (not diluted) is to be considered as highly irritating.
- Executive summary:
Primary eye irritation / corrosion of Octopirox was investigated in rabbits according to FDA guidelines. 50 mg of the undiluted test material was applied into the left eye of 8 rabbits, The right eye left untreated in all cases and served as a control. After 5 minutes exposure time the treated eye of 5 animals was rinsed for 2 minutes with warm tap water (group 1). In the remaining 3 animals the treated eyes were rinsed after 24 hours exposure time (group 2). Assessments were carried out 1, 24, 48 and 72 hours after rinsing of the eyes as well as 7 and 14 days. After application of the test substance the animals of group 1 exhibited definitely injected blood vessels of the conjunctiva as well as swellings with lids about half closed. The cornea showed easily translucent areas with details of the iris slightly obscured. In group 2 the conjunctiva of the animals had a diffuse beefy red clour as well as swellings with lids about half closed and the cornea showed nacreous areas of opacity with details of the iris not visible. Based on the severity of the effects observed they were judged to be irreverible.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.