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EC number: 218-871-2 | CAS number: 2269-22-9
- 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
Endpoint summary
Administrative data
Description of key information
Upon contact with water or moisture (e.g. within mucous membranes) aluminium tri-sec-butanolate hydrolyses immediately to butan-2-ol and aluminium 3+ cations (as hydroxide and oxyhydroxide). Hence, toxicity is determined by the toxicity of these two species.
The acute oral toxicity of butan-2-ol in rat as expressed as LD50 is 2193 mg/kg bw (Price 1986). For aluminium nitrate and aluminium tri-isopropanolate oral LD50 values of 4280 mg/kg and 11300 mg/kg bw are reported (Smyth 1969).
For acute inhalation toxicity no LC50 could be derived for butan-2-ol and a LC50 of 888 mg/m3 for aluminium flakes were derived (Reynolds 1986).
The dermal LD50 for butan-2-ol in rats is >2000 mg/kg bw (Price 1986).
Butan-2-ol showed local irritant effects on the respiratory system and transient effects on the CNS (drowsiness and dizziness) and is therefore classified as STOT SE 3, H335/H336 (according to Annex VI of Regulation EC 1272/2008).
Aluminium species (hydroxide or oxide) that may be formed during hydrolysis are not classified for acute toxicity.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study without detailed documentation.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- -reliability scoring was based on 2001 guideline
- Deviations:
- yes
- Remarks:
- -insignificant deviation, guideline suggests using animals of all the same sex; no necropsy conducted
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River U.K. Ltd.
- Age at study initiation: 9 to 11 weeks old
- Weight at study initiation: Weight on Day 1 = 189 to 219 g (males) and 125 to 149 g (females)
- Fasting period before study: Fasted overnight (18 h) prior to dosing.
- Housing: Two days before dosing, the rats to be used were housed in groups of 2 or 3 animals of the same sex per cage.
- Diet (e.g. ad libitum): Food (PRD, Labsure Animal Foods, Dorset), ad libitum
- Water (e.g. ad libitum): Filtered but untreated water from the public supply, ad libitum
- Acclimation period: not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): air temperature was 19 to 25 °C
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: not reported
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Range finding studies were performed. - Doses:
- 950, 1200, 1500, 2000, and 2400 mg/kg bw
- No. of animals per sex per dose:
- 5 rats/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Rats were observed for clinical signs over 14 days. Body weight measurements were recorded on Days 1, 7, and 14.
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight - Statistics:
- Acute oral LD50 values were calculated using probit analysis (Finney, 1977).
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 2 054 mg/kg bw
- Remarks on result:
- other: 95% fiducial limits were 1283 - 4018 mg/kg bw
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 2 328 mg/kg bw
- Remarks on result:
- other: 95% fiducial limits were 1470 - 5428 mg/kg bw
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 193 mg/kg bw
- Remarks on result:
- other: 95% fiducial limits were 1608 - 4146 mg/kg bw
- Mortality:
- Over the 14-day observation period, 0, 1, 2, 1, and 8 animals died in the 950, 1200, 1500, 2000, and 2400 mg/kg bw dose groups, respectively. For more details, refer to Table 1 (attached).
- Clinical signs:
- other: All rats at all dose levels had gait and/or posture abnormalities. In the higher dose groups some rats were comatose or prostrate within a few hours of dosing, with some animals being unconscious for 24 hours or more. Some rats in the top dose group (2400
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50 (male/female rat) was determined being 2193 mg/kg bw
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 193 mg/kg bw
- Quality of whole database:
- Based on the available study on the hydrolysis product butan-2-ol
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Quality of whole database:
- In the available study on the most volatile hydrolysis product butan-2-ol no value for LC50 could be derived.
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented, according to accepted guidelines.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- -reliability scoring based on 1987 guideline
- Deviations:
- yes
- Remarks:
- -insignificant deviation, guideline suggests using animals of all the same sex
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River U.K. Ltd.
- Age at study initiation: 9 to 11 weeks old
- Weight at study initiation: Weight on Day 1 = 227 to 265 g (males) and 153 to 170 g (females)
- Fasting period before study: Fasted overnight (18 h) prior to dosing.
- Housing: Two days before dosing, the rats to be used were housed in groups of 2 or 3 animals of the same sex per cage.
- Diet (e.g. ad libitum): Food (PRD, Labsure Animal Foods, Dorset), ad libitum; however, food was withheld 24 hours after administration
- Water (e.g. ad libitum): Filtered but untreated water from the public supply, ad libitum
- Acclimation period: not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): air temperature was 19 to 25 °C
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal
- % coverage: not reported
- Type of wrap if used: The test material was covered with a piece of aluminum foil which was held in place by a double over-wrap of waterproof adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period, the tape and foil were carefully removed and the skin was washed with warm dilute detergent solution and then dried.
- Time after start of exposure: 24 hrs
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): not reported
- Concentration (if solution): undiluted
- Constant volume or concentration used: not applicable
- For solids, paste formed: not applicable - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals/sex
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for signs of toxicity for 14 days after dosing. Body weights were recorded on Days 1, 7, and 14.
- Necropsy of survivors performed: No
- Other examinations performed: clinical signs and body weight - Statistics:
- Statistical analysis was not performed, but is not required.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: The LD50 value was not determined since none of the rats died at a dose level of 2000 mg/kg bw. The LD50 value was predicted to be greater than 2000 mg/kg bw.
- Mortality:
- None of the rats died over a period of 14 days.
- Clinical signs:
- other: There were no clinical signs seen.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50 (dermal, rat) >2000 mg/kg bw
- Executive summary:
The acute (24 h) percutaneous LD50 of the undiluted test material in rats was greater than 2000 mg/kg bw. None of the rats died during the 14 day observation period following dermal exposure to 2000 mg/kg bw 2 -butanol.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Aluminium hydroxide, aluminium oxide, aluminium oxyhydroxide are insoluble in water. Due to their insolubility it can be assumed that the absorption of these aluminium compounds via the skin will be limited. Therefore the LD50 is based on the other hydrolysis product butan-2-ol
Additional information
Upon contact with water or moisture (e.g. within mucous membranes) aluminium tri-sec-butanolate hydrolyses immediately to butan-2-ol and aluminium 3+ cations (as hydroxide and oxyhydroxide). Hence, toxicity is determined by the toxicity of these two species.
Justification for classification or non-classification
Upon contact with water or moisture (e.g. within mucous membranes) aluminium tri-sec-butanolate hydrolyses immediately to butan-2-ol and aluminium 3+ cations (as hydroxide and oxyhydroxide). Hence, toxicity is determined by the toxicity of these two species. Aluminium species are not classified for acute toxicity, but butan-2-ol is classified as STOT SE 3, H335/H336 (according to Annex VI of Regulation EC 1272/2008). Therefore aluminium tri-sec-butanolate will be classified as H335 and H336 in a worst case approach.
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