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EC number: 701-182-0 | CAS number: -
- 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
- Study period:
- 26 June 2001 to 12 July 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- (octadecanoato-O)oxoaluminium
- EC Number:
- 236-521-7
- EC Name:
- (octadecanoato-O)oxoaluminium
- Cas Number:
- 13419-15-3
- Molecular formula:
- C18H35AlO3
- IUPAC Name:
- (octadecanoato-kappaO)(oxo)aluminum
- Test material form:
- other: Solid. The test article was stored in the dark under nitrogen immediately prior to formulation.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: Young adult animals approximately 7 weks old
- Weight at study initiation: The bodyweight variation did not exceed ±20% of the sex mean
- Fasting period before study: Food was withheld overnight (for a maximum of 20 hours) prior to dosing until approximately 3-4 hours after administration of the test substance.
- Housing: Group housing of three animals per sex per cage in laballed cages (type IV; height 15 cm) containing purified sawdust as bedding.
- Diet: Free access to standard pelleted laboratory animal diet supplied by Altromin (code VRF 1), Lage, Germany
- Water: Free access to tap water
- Acclimation period: At least five days
ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 3 °C
- Humidity: Relative humidity 30 to 70%
- Air changes: The rate of air exchange was at approximately fifteen changes per hour
- Photoperiod: 12 hours artificial fluorescent light and 12 hours dark per day
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Poly alpha olefin
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: The formulations (w/w) were prepared within 4 hours prior to dosing to give a dose level of 2000mg/kg bodyweight
- Amount of vehicle: Not stated
- Justification for choice of vehicle: The vehicle was selected based on information provided by the sponsor
- Lot/batch no. (if required): Not stated
- Purity: Not stated
MAXIMUM DOSE VOLUME APPLIED: 10mL/kg bodyweight
DOSAGE PREPARATION (if unusual): To dissolve the substance, ethyl acetate was added to the test substance (final concentration in formulation preferably below 30%). After mixing, poly alpha olefin (supplied by sponsor) was added until the requested concentration was reached. This preparation method was selected, in mutual agreement with the sponsor, to facilitate dosing of a homogeneous formulation. It was indicated by the sponsor that by using this method the test substance is stable.
CLASS METHOD (if applicable)
- Ration for the selection of the starting dose: The toxicity of the test substance was assessed by stepwise treatment of groups of three animals. The first group was treated at a dose level of 2000 mg/kg bodyweight. The absence or presence of mortality of animals dosed at one step determined the next step, based on the test procedure defined in the guidelines. The onset, duration and severity of the signs of toxicity were taken into account for determination of the time interval between the dose groups. - Doses:
- Three females dosed at 2000 mg/kg bodyweight, followed two days later by three males dosed at 2000 mg/kg bodyweight.
- No. of animals per sex per dose:
- 3 females at 2000 mg/kg bodyweight
3 males at 2000 mg/kg bodyweight - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were made on the day of dosing (day 1) and once daily thereafter, until day 15. Mortality/viability checks were made twice daily. Individual bodyweights were recorded on Day 1 (the day of dosing) and on Days 8 and 15.
- Necropsy of survivors performed: Yes - Statistics:
- No statistical analysis was performed.
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- - Lethal results: There were no deaths
- Clinical signs:
- other: - Non-lethal results: Lethargy, hunched posture and piloerection were noted among animals between days 1 and 3.
- Gross pathology:
- - Gross pathology results: No abnormalities were noted at macroscopic post mortem examination of the animals.
- Other findings:
- No data reported
Any other information on results incl. tables
Table1: Clinical Signs
Test Day |
1 |
1 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
Hours After Treatment |
0 |
2 |
4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Female at 2000 mg/kg |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Animal 1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Behaviour - Lethargy |
- |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Posture – Hunched Posture |
- |
- |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Skin/Fur/Plumage - Piloerection |
- |
- |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Female at 2000 mg/kg |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Animal 2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Behaviour - Lethargy |
- |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Posture – Hunched Posture |
- |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Skin/Fur/Plumage - Piloerection |
- |
- |
1 |
1 |
|
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Female at 2000 mg/kg |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Animal 3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Behaviour - Lethargy |
- |
2 |
2 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Posture – Hunched Posture |
- |
1 |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Skin/Fur/Plumage - Piloerection |
- |
- |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Male at 2000 mg/kg |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Animal 1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Behaviour - Lethargy |
- |
1 |
. |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Posture – Hunched Posture |
- |
1 |
. |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Skin/Fur/Plumage - Piloerection |
- |
1 |
. |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Male at 2000 mg/kg |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Animal 2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Behaviour - Lethargy |
- |
1 |
. |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Posture – Hunched Posture |
- |
1 |
. |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Skin/Fur/Plumage - Piloerection |
- |
1 |
. |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Male at 2000 mg/kg |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Animal 3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Behaviour - Lethargy |
- |
1 |
. |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Posture – Hunched Posture |
- |
1 |
. |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Skin/Fur/Plumage - Piloerection |
- |
1 |
. |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Applicant's summary and conclusion
- Interpretation of results:
- other: Criteria for classification as an acute oral toxicant not met
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral median lethal dose (LD50) of in both the male and female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight.
- Executive summary:
Introduction.
The study was performed to assess the acute oral toxicity of the test material in the Wistar strain rat.The acute oral toxicity of the test item to the Wistar strain rat was assessed in a GLP-compliant study following OECD guideline 423 (adopted 1996) andEU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)in a proprietary, experimental study (NOTOX 2013). The study is considered reliable and relevant for use for this endpoint.
Method.
A group of three fasted females was given a single oral dose of test material, as a suspension in poly alpha olefin, at a dose level of 2000 mg/kg bodyweight. A group of three fasted males were treated in the same way. Clinical signs and bodyweight development were monitored during the study period of 15 days (starting from day of dosing). All animals were subjected to gross necropsy.
Mortality.
There were no deaths.
Clinical Observations.
Lethargy, hunched posture and piloerection were noted among animals between days 1 and 3.
Bodyweight.
The mean bodyweight gain shown by the animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain.
Necropsy.
No abnormalities were noted at macroscopic post mortem examination of the animals..
Conclusion.
The acute oral median lethal dose (LD50) of in both the male and female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight.
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