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Diss Factsheets
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EC number: 700-661-1 | 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:
- supporting study
- Study period:
- 2011-08-05 to 2011-09-13
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A GLP study performed to a standardised guideline with a sufficient level of detail to assess the quality of the relevant results. Since there was no top dose the study has been assigned a reliability score of 2.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- (no top dose following flow chart due to corrosivity of the test material)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Sprague Dawley Crl:CD(SD)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Margate, UK
- Age at study initiation: 7 - 8 weeks
- Weight at study initiation: 180 - 192 g
- Housing: groups of 3
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 21 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 22 °C
- Humidity (%): 44 - 63 %
- Air changes (per hr): 10 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: see "Details on oral exposure"
- Details on oral exposure:
- VEHICLE
The vehicle used in this study was 20 % (v/v) "Labrasol" in acetate buffer (0.1 M acetic acid and 0.1 M sodium acetate anhydrous). This was selected on the basis of a pre-study formulation trial which found the following vehicles to be unsuitable since none produced a satisfactory solution: 0.9 % (w/v) sodium chloride solution, 10 % propylene glycol in 0.9 % sodium chloride solution, Milil-Q water, propylene glycol in Milli-Q water and 0.2 % Tween in Milli-Q water. All vehicles were tested at a concentration of 3 mg/mL.
CLASS METHOD
- Rationale for the selection of the starting dose: it was decided that the test material formulation should not exceed 3 mg/mL because of the risk of corrosivity. An initial dose level of 50 mg/kg was selected for group 1 animals. All animals survived and there were no adverse signs in any animal. Consequently, it was decided to increase the concentration of the formulation to 7.5 mg/mL in order to achieve a dose level of 300 mg/kg for group 2 animals. Only a single, transitory adverse sign was recorded and so a third group of animals was treated at the same dose level. There were no adverse signs in any animal in this group. However, since higher concentrations of test material administered formulations carried a potential to cause corrosivity, no further treatment was deemed necessary. - Doses:
- 50, 300 mg/kg
- No. of animals per sex per dose:
- 3 females per goup
(3 females dosed at 50 mg/kg and two groups of 3 females dosed at 300 mg/kg) - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: all animals were checked twice daily for viability and once daily for clinical observations. The body weight of each animal was recorded before dosing on day 1 and on days 8 and 15.
- Necropsy of survivors performed: yes. Necropsy consisted of an examination of the cranial, thoracic and abdominal organs and tissues in situ. - Statistics:
- No formal statistical analysis was conducted.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no unscheduled deaths.
- Clinical signs:
- other: Adverse clinical signs were restricted to hunched posture, which was recorded in one animal that received 300 mg/kg. This sign was observed at approximately 1 hour and approximately 1¾ hours after administration of the second dose fraction. No other adver
- Gross pathology:
- There were no macroscopic abnormalities at necropsy on day 15.
Applicant's summary and conclusion
- Interpretation of results:
- other: The EU criteria for classification could not be applied since the test material was not administered at the 2000 mg/kg dose level.
- Conclusions:
- Under the conditions of the study, the LD50 of the test material was determined to be in excess of 300 mg/kg.
- Executive summary:
The acute oral toxicity of the test material was investigated under GLP conditions in accordance with the standardised guideline OECD 423. During the study the test material was administered to three groups of female rats, by oral gavage, at concentrations of 50 and 300 mg/kg. Mortality, clinical signs and body weight were recorded and a gross necropsy was performed on all animals. Under the conditions of the study there were no unscheduled deaths. Clinical signs were restricted to hunched posture, which was recorded in one animals that received 300 mg/kg. This sign was observed at approximately 1 hour and approximately 1¾ hours after administration of the second dose fraction. No other adverse signs were recorded. Body weight gains were considered to be acceptable for rats of this age and strain and no macroscopic abnormalities were recorded in any animal. The LD50 of the test material was subsequently determined to be in excess of 300 mg/kg.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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