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EC number: 482-070-6 | CAS number: 1001354-72-8
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Standard OECD Guideline study conducted according to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 482-070-6
- EC Name:
- -
- Cas Number:
- 1001354-72-8
- Molecular formula:
- C8-H19-N-O
- IUPAC Name:
- (3R,4R)-3-aminooctan-4-ol; (3R,4S)-3-aminooctan-4-ol; (3S,4R)-3-aminooctan-4-ol; (3S,4S)-3-aminooctan-4-ol
- Details on test material:
- TEST SUBSTANCE IDENTIFICATION: Octanolamine, (XU-12314.00)
Lot #CEC-200601419-43
TEST SUBSTANCE DESCRIPTION: Colorless to yellow liquid
pH: 12.5
Solubility: Miscible in water.
Stability: Test substance was expected to be stable for the duration of testing.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Housing: The animal was singly housed in suspended stainless steel caging with mesh floors which conform to the size recommendations in the most recent Guide for the Care and Use of Laboratory Animals DHEW (NIH). Litter paper was placed beneath the cage and was changed at least three times per week.
Animal Room Temperature: 19-21°C
Relative Humidity: see Section 9
Photoperiod: 12-hour light/dark cycle
Acclimation Period: 8 days
Feed: Purina Certified High Fiber Rabbit Diet (PMI #5325).
Water: Filtered tap water was supplied ad-libitum by an automatic water dispensing
system.
Contaminants: There were no known contaminants reasonably expected to be found in the food or water at levels which would have interfered with the results of this study. Analysis of the water is conducted at least once a year and the records are kept on file at Eurofins | Product Safety Laboratories. The most recent analysis was conducted in September 2006.
Purina Certified High Fiber Rabbit Diet, PMI #5325, Lot Number:
JUL 08 06 3A, was analyzed in July 2006.
Cage: The cage was identified with a cage card indicating at least the study number and identification and sex of the animal.
Animal: A number was allocated to the rabbit on receipt and a stainless steel ear tag bearing this number was attached to the animal. This number, together with a sequential animal number assigned to study 20361, constituted unique identification.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 ml of neat test substance was applied to the dose site (6 cm2 in dimension)
- Duration of treatment / exposure:
- 1 hour
- Observation period:
- The study was terminated at the 1 hour time point due to necrosis
- Number of animals:
- 1, Female. The animal assigned to test was nulliparous and non-pregnant.
- Details on study design:
- Initial testing was conducted on one rabbit to determine the irritation/corrosion potential of the test substance. Three test sites, each approximately 6-cm2, were delineated on this rabbit. Five-tenths of a milliliter of the test substance was applied to each dose site and covered with a 1-inch x 1-inch, 4- ply gauze pad. The pad and entire trunk of each animal were then wrapped with semi-occlusive 3- inch Micropore tape to avoid dislocation of the patch. The patches were removed at the appropriate intervals (3 minutes and 1-hour). The test sites were evaluated for corrosion 30-60 minutes after patch removal. Due to corrosion at the 1-hour test site, the 4-hour patch was removed at the same time as the 1-hour patch.
Results and discussion
In vivo
Results
- Irritation parameter:
- other: Necrosis
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Reversibility:
- other: study terminated after 1 hour so reversibility not assessed
- Remarks on result:
- other: substance was corrosive
- Irritant / corrosive response data:
- Substance was corrosive after 1 hour of exposure
Any other information on results incl. tables
The animal appeared active and healthy during the study. Apart from the skin irritation/corrosion noted below, there were no other signs of gross toxicity, adverse clinical signs, or abnormal behavior. One hour after patch removal, from the 3-minute dose site, well-defined erythema and slight edema were noted. Severe erythema, slight edema, and corrosion were noted at the 1-hour site one hour after patch removal. Due to corrosion noted at the 1-hour test site, the study was terminated and the animal was euthanized for humane reasons.
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, XU-12314.00 caused corrosion to the skin when applied for one
hour. - Executive summary:
A primary skin irritation test was conducted with a single rabbit to determine the potential for XU- 12314.00 to produce irritation and/or corrosion after topical application. Under the conditions of this study, the test substance was corrosive to the skin. Initially, one rabbit was tested to determine the irritation/corrosion potential of the test substance. Three test sites, each approximately 6-cm2, were delineated on this animal. Five-tenths of a milliliter of the test substance was applied to each dose site and covered with a 1-inch x 1-inch, 4-ply gauze pad. The pad and entire trunk of the animal was then wrapped with semi-occlusive 3-inch Micropore tape to avoid dislocation of the patches. The patches were removed at the appropriate intervals (3 minutes and 1- hour). The test sites were evaluated for corrosion 60 minutes after patch removal. Due to corrosion at the 1-hour test site, the 4-hour patch was removed at the same time as the 1-hour patch. The 3-minute and 1- hour test sites were also evaluated for skin irritation according to the Draize1 scoring system at 60 minutes after the patch removal. Since corrosion was noted at the 1-hour test site, the study was terminated and the animal was euthanized for humane reasons. One hour after patch removal, well-defined erythema and slight edema were noted at the 3-minute dose site. Severe erythema, slight edema, and corrosion were noted at the 1-hour site one hour after patch removal. Due to corrosion noted at the 1-hour test site, the study was terminated and the animal was euthanized for humane reasons.
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