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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
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study is not a standard guideline study, but was well reported and conducted in the spirit of GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Groups of three male and three female Fischer 344 rats were dermally exposed six hours/day, five days/week for 10 days to dose solution concentrations of 0, 50, 100, or 150 mg/ml octanolamine (pH-adjusted to 9.5) in distilled water at dose volumes of 1 or 4 ml dose solution/kg body weight. This was equivalent to 0, 50, 100, or 150 mg /kg body weight/day (mg/kg/day, mkd) at a dose volume of 1 ml/kg and 0, 200, 400, or 600 mg/kg/day at a dose volume of 4 ml/kg. Parameters evaluated included cage-side observations, dermal observations, body weights. and body weight gains.
- GLP compliance:
- no
- Remarks:
- not a guideline study
- Limit test:
- no
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 was Octanolamine (pH adjusted to 9.5)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344/DuCrj
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- The test material or vehicle (distilled water) was applied as a solution directly to the skin for six hours/day, five days/week.
- Frequency of treatment:
- daily, 5 times a week for 2 weeks.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
50, 100, 150, 200, 400, 600
Basis:
nominal per unit body weight
- No. of animals per sex per dose:
- 3 male
3 female - Control animals:
- yes, concurrent vehicle
- Positive control:
- None
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Dermal irritation:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- ca. 100 mg/kg bw/day (nominal)
- Sex:
- female
- Basis for effect level:
- other: overall effects (bodyweight, food consumption, local dermal effects)
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
1 ml/kg Dose Volume Group
Two male rats dosed with 150 mg/kg/day were noted with very slight erythema on test day 2. Following the 6-hour dosing period on test day 3, one male rat had very slight erythema and two males had well-defined erythema. After dosing on test day 4, one male rat was noted with very slight erythema and the remaining two males were noted with severe erythema and burns. All three male rats in this dose group were immediately euthanized. All three females in this dose group (150 mkd) had slight scaling following the 6-hour dosing period on test day 11. On test day 12, two females had slight erythema and burns of the dermal test site. All three females in this dose group were immediately euthanized. There were no dermal observations for any animal in the 0, 50, or 100 mg/kg dose groups throughout the study.
4 ml/kg Dose Volume Group
On test day 1, following a single 6-hour dosing period, all males and one female dosed with 600 mg/kg/day had burns of the dermal test site. All animals (3 males and 3 females) in this dose group were immediately euthanized. All three male rats dosed with 400 mg/kg/day had very slight to slight erythema, very slight edema and burns of the dermal test site following the 6-hour dosing period on test day 2. These animals were immediately euthanized. All three females in this dose group had very slight edema on test day 2 and very slight erythema and edema on test day 3. These females had very slight edema and very slight to severe erythema, and two of the three females had burns of the dermal test site following the 6-hour dosing period on test day 4. All three female rats in this dose group were immediately euthanized. Slight scaling was observed in all three female rats dosed with 200 mg/kg/day following the 6- hour dosing period on test day 11. There were no dermal observations noted for any control animals or for males in the 200 mg/kg dose group throughout the study. The cumulative study mean body weight gain for male rats dosed with 200 mg/kg/day was 10 grams less than that of the respective control group mean. There were no differences in the body weights or body weight gains of male or female rats in any other dose group when compared to their respective controls.
The Summary tables of results are attached in the document below.
Applicant's summary and conclusion
- Conclusions:
- Conclusions
Under the conditions of this study, the no-observed-effect levels (NOEL) for dermal effects for Fischer 344 rats following 10 days of six hour/day
dermal exposure to octanolamine were the targeted concentrations of 200 mg/kg/day (dose solution concentration of 50 mg/ml (5%) at a volume of 4 ml/kg) for males, and 100 mg/kg/day (dose solution concentration of 100 mg/ml (10%) at a volume of 1 ml/kg) for females (equivalent to 0.44 mg/cm2). - Executive summary:
Groups of three male and three female Fischer 344 rats were dermally exposed six hours/day, five days/week for 10 days to dose solution concentrations of 0, 50, 100, or 150 mg octanolamine/ml distilled water at dose volumes of 1 or 4 ml dose solution/kg body weight. This was equivalent to 0, 50, 100, or 150 mg /kg body weight/day (mg/kg/day, mkd) at a dose volume of 1 ml/kg and 0, 200, 400, or 600 mg/kg/day at a dose volume of 4 ml/kg. Parameters evaluated included cage-side observations, dermal observations, body weights. and body weight gains.
1 ml/kg Dose Volume Group
Two male rats dosed with 150 mg/kg/day were noted with very slight erythema on test day 2. Following the 6-hour dosing period on test day 3, one male rat had very slight erythema and two males had well-defined erythema. After dosing on test day 4, one male rat was noted with very slight erythema and the remaining two males were noted with severe erythema and burns. All three male rats in this dose group were immediately euthanized. All three females in this dose group (150 mkd) had slight scaling following the 6-hour dosing period on test day 11. On test day 12, two females had slight erythema and burns of the dermal test site. All three females in this dose group were immediately euthanized. There were no dermal observations for any animal in the 0, 50, or 100 mg/kg dose groups throughout the study.
4 ml/kg Dose Volume Group
On test day 1, following a single 6-hour dosing period, all males and one female dosed with 600 mg/kg/day had burns of the dermal test site. All animals (3 males and 3 females) in this dose group were immediately euthanized. All three male rats dosed with 400 mg/kg/day had very slight to slight erythema, very slight edema and burns of the dermal test site following the 6-hour dosing period on test day 2. These animals were immediately euthanized. All three females in this dose group had very slight edema on test day 2 and very slight erythema and edema on test day 3. These females had very slight edema and very slight to severe erythema, and two of the three females had burns of the dermal test site following the 6-hour dosing period on test day 4. All three female rats in this dose group were immediately euthanized. Slight scaling was observed in all three female rats dosed with 200 mg/kg/day following the 6 - hour dosing period on test day 11. There were no dermal observations noted for any control animals or for males in the 200 mg/kg dose group throughout the study.
The cumulative study mean body weight gain for male rats dosed with 200 mg/kg/day was 10 grams less than that of the respective control group mean. There were no differences in the body weights or body weight gains of male or female rats in any other dose group when compared to their respective controls.
Conclusion
Under the conditions of this study, the no-observed-effect levels (NOEL) for dermal effects for Fischer 344 rats following 10 days of six hour/day dermal exposure to octanolamine were the targeted concentrations of 200 mg/kg/day (dose solution concentration of 50 mg/ml (5%) at a volume of 4 ml/kg) for males, and 100 mg/kg/day (dose solution concentration of 100 mg/ml (10%) at a volume of 1 ml/kg) for females (equivalent ot 0.44 mg/cm2).
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