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Diss Factsheets
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EC number: 309-363-2 | CAS number: 100231-63-8
- 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:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 17 Dec 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Sécrétariat général du GIPC, Paris, France
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- not applicable, UVCB substance
- Molecular formula:
- not applicable, UVCB substance
- IUPAC Name:
- not applicable, UVCB substance
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage JANVIER, Le Genest St Isle, France
- Age at study initiation: 8 weeks
- Weight at study initiation: 190-202 g
- Fasting period before study: food removed on day before until 4 hours after test item administration
- Housing: groups of 3 in solid-bottomed clear polycarbonate cages with stainless steel mesh lid. Each cage contained sawdust bedding which was changed at least 2 times a week.
- Diet: pelleted M20 rat/mouse maintenance diet (EXTRALABO from PIETREMENT), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23
- Humidity (%): 32-62
- Air changes (per hr): conventional air-conditioned, not further specified
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE
- Amount of vehicle: 2 mL/kg bw water for control group
MAXIMUM DOSE VOLUME APPLIED: 1.69 mL/kg bw - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 females
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 30 min, 1 hour, 3 and 4 hours after dosing and daily thereafter for mortality and behavioural or toxic effects on the major physiological functions (spontaneous activity), Preyer's reflex (noise), respiratory rate, convulsions, tremors, body temperature, muscle tone, palpebral opening, pupil appearance, salivation, lachrymation, righting reflex, back hair appearance. These observations were compared to control data. Weighing was done on Day 0 just before administration and on Days 2, 7, and 14. Weight changes were calculated and recorded.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, other: gross pathological changes of esophagus, stomach, duodenum, jejunum, ileum, caecum, colon, rectum, spleen, liver, thymus, trachea, lungs heart, kidneys, urinary bladder, ovaries, uterus, adrenals, pancreas.
Results and discussion
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: LD50 cut-off according to OECD 423
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: No clinical signs related to test item administration were observed.
- Gross pathology:
- The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.
Any other information on results incl. tables
The LD50 of the test item is higher than 5000 mg/kg bw by oral route in the rat, in accordance with OECD guideline 423. According to the criteria of Regulation (EC) No. 1272/2008 (CLP) the test item does not have to be classified.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
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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