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EC number: 236-109-7 | CAS number: 13170-05-3
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Bis[4-(tert-butyl)benzoato-O]hydroxyaluminium
- EC Number:
- 236-109-7
- EC Name:
- Bis[4-(tert-butyl)benzoato-O]hydroxyaluminium
- Cas Number:
- 13170-05-3
- Molecular formula:
- C22H27AlO5
- IUPAC Name:
- aluminum hydroxide bis(4-tert-butylbenzoate)
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- no details given
Test animals
- Species:
- mouse
- Strain:
- other: Kuming mice
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Shanghai SLAC Laboratory Animal Co., Ltd. (Production License: SCXK (Hu) 2007-0005. Animal Use License: SYXK (Hu) 2007-0008).
- Age: 4-5 weeks old
- Weight at study initiation: The body weight range of male mice was 19 - 22 g, and that of female mice was 19 - 22g.
- Housing: Animals were housed in the suspended cages (L46xW31xH20cm) by their sex, 10 animals per cage. Cages were replaced twice weekly.
- Diet (e.g. ad libitum): laboratory diet was provided by Suzhou Shuangshi Laboratory Animal Feed Science and Technology Ltd. (Production License: Su (E) Sishengzi (2002) 006).
- Water (e.g. ad libitum): Laboratory drinking water was offered for free access. The water meets the Chinese "Hygiene standard for drinking water" (GB5749-2006).
- Fasting period before study: 16 hours
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 40-70
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
According to the data supplied by the sponsor, the test substance is insoluble in water. But this powder could be dissolved in corn oil to form a suspension liquid. Then the suspension can be mixed homogeneously for administrating.
According to the request of the limit test, 5000mg of the test substance were weighed, and dissolved into corn oil to 20ml. The solution was mixed evenly for future use.
MAXIMUM DOSE VOLUME APPLIED: Test substance was administered to the mice via a single oral gavage. The gavage volume was 0.4 ml per 20 g body weight. - Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5000mg/kg bw: 10 female mice, 10 male mice
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days (5000 mg/kg bw)
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, mortality and viability, histopathology, body weights were recorded once a week prior to administration and after administration. - Statistics:
- According to the mortality number of each dose group, the median lethal dose (LD50) and 95% confidence limit of this acute oral toxicity study in mice was calculated.
Results and discussion
- Preliminary study:
- After administration, no obvious toxicity symptoms were observed.
Results of death in preliminary test: No death was observed in this study.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- 5000 mg/kg bw: 0/10
- Clinical signs:
- other: no toxicity symptoms detected
- Gross pathology:
- no abnormalities detected
- Other findings:
- Macroscopic findings: No pathological changes were observed
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Acute oral toxicity study: The acute oral LD50 of the test substance for male and female mice was both greater than 5,000 mg/kg.
Toxicity classification: virtually non toxic. - Executive summary:
Acute oral toxicity was analyzed in a study performed in large part equivalent to method described in OECD guideline 401.
The test substance, Bis(4-(tert-butyl)benzoate-0) hydroxyaluminium (CAS No. 13170-05-3), was used to perform the acute oral toxicity study in mice. The test substance was suspended in corn oil. The dose of 5,000 mg/kg was administrated to male and female mice, respectively (10 male and 10 female mice). The sample solution was administered to all mice by a single oral gavage. The gavage volume was 0.4 ml per 20 g body weight. All animals were examined for clinical observation, mortality and viability after treatment on daily basis for 14 days. Body weights were recorded once a week prior to administration and after administration.
After administration, no toxicological symptoms and mortality were observed in mice. No abnormal change was observed among organs of animals after observation period.
The acute oral LD50 of the test substance for male and female mice was both greater than 5,000 mg/kg. Toxicity classification: virtually non-toxic.
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