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Diss Factsheets
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EC number: 471-920-1 | 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:
- key study
- Study period:
- 07 November 2005 - 28 November 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Protocol that complies with scientifically accepted methods, and is sufficiently detailed.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Details on test material:
- - Physical state: dark amber slightly viscous liquid
- Analytical purity: No data
- Stability under test conditions: undetermined
- Storage condition of test material: room temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Age at study initiation: 8-12 weeks old
- Weight at study initiation: 189-218 g
- Fasting period before study: Feed (not water) was withheld overnight prior to dosing.
- Housing: The animals were housed in groups of three in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): Certified Rat and Mouse Diet (Code 5LF2) supplied by BCM IPS Limited, London, UK was provided ad libitum
- Water (e.g. ad libitum): tap water was available ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Air changes (per hr): at least 15/hour
- Photoperiod (hrs dark / hrs light): 12 h light/dark cycle.
IN-LIFE DATES: From: 07/11/2005 To: 28/11/2005.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: Not applicable.
- Amount of vehicle (if gavage): Not applicable.
- Justification for choice of vehicle: Not applicable.
- Lot/batch no. (if required): Not applicable.
- Purity: Not applicable.
MAXIMUM DOSE VOLUME APPLIED:
DOSAGE PREPARATION (if unusual): Not applicable
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Based on consideration of all available information on the toxicity of the test material - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 2 groups of 3 females/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed for deaths or overt signs of toxicity 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days. Individual bodyweights were recorded prior to dosing and seven and fourteen days after treatment.
- Necropsy of survivors performed: gross necropsies were performed on all animals after sacrifice at the conclusion of the 14 day observation period. - Statistics:
- No data available
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Number of animals: 6; Number of deaths: 0
- Clinical signs:
- other: There were no signs of systemic toxicity.
- Gross pathology:
- No gross abnormalities were noted in all animals
Any other information on results incl. tables
Table 1: Individual bodyweights and weekly bodyweight changes
Dose level (mg/kg) |
Animal No. & sex |
Bodyweight (g) at Day |
Bodyweight gain (g) during Week |
|||
0 |
7 |
14 |
1 |
2 |
||
2000 |
1-0 female |
218 |
246 |
277 |
28 |
31 |
1-1 female |
200 |
232 |
264 |
32 |
32 |
|
1-2 female |
217 |
259 |
280 |
42 |
21 |
|
2-0 female |
189 |
223 |
236 |
34 |
13 |
|
2-1 female |
209 |
249 |
262 |
40 |
13 |
|
2-2 female |
213 |
254 |
264 |
41 |
10 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test article, when administered as received to female Sprague-Dawley rats, had an acute oral LD50 of greater than 2500 mg/kg bodyweight
- Executive summary:
Test Guidance
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Method and material
In an acute oral toxicity study, two groups of fasted Sprague-Dawley rats (three females/group) were given a single oral dose by gavage of undiluted test material at a dose level of 2000 mg/kg bw and observed for 14 days.
Results
There were no deaths or clinical signs of toxicity during the study. Animals showed expected gains in bodyweight. Gross pathologic examination revealed nothing remarkable. The oral LD50 of the test material in female rats has been determined to be greater than 2500 mg/kg bw.
Conclusion
In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for acute oral toxicity
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.
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