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Diss Factsheets
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EC number: 468-740-0 | 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:
- 2 June 2005 to 5 August 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted under GLP conditions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- other: JMAPP guidelines (2000) including the most recent partial revisions.
- GLP compliance:
- yes
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- MTDID 3285
- IUPAC Name:
- MTDID 3285
- Details on test material:
- - Name of test material (as cited in study report: MTDID 3285
- Molecular formula (if other than submission substance):
- Molecular weight (if other than submission substance):
- Smiles notation (if other than submission substance):
- InChl (if other than submission substance):
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type: light brwon waxy chunks
- Physical state: solid
- Analytical purity: minimum 86%
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Isomers compositon:
- Purity test date:
- Lot/batch no.: Lot 30045
- Expiration date of the lot/batch: 01 June 2006
- Radiochemical purity (if radiolabelling):
- Specific activity (if radiolabelling):
- Locations of label (if radiolabelling):
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature in the dark
- Other: Molecular weight: 610. pH: 9.8 (in 1% water). Stability in vehicle (propylene glycol): unknown.
Solubility in vehicle: No
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Wistar strain Crl:WI (outbred, SPF-Quality)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: approximately 9 weeks old
- Weight at study initiation: 186 to 223 grams
- Fasting period before study: overnight (maximum of 20 hours) prior to dose until 3-4 hours after administration of test article.
- Housing:- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.3-23 degrees C
- Humidity (%): 35-87% (above optimal humidity, but not expected to affect study integrity.
- Air changes (per hr): 15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light/ 12 hours dark
IN-LIFE DATES: From: 02 June 2005 To: 17 June 2005
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Details on oral exposure:
- VEHICLE
- Justification for choice of vehicle: based on trial formulations performed at NOTOX and on test substance data supplied by the sponsor.
- maximum dose volume applied: 2000 mg/kg (10 ml/kg) body weight - Doses:
- 2000 mg/kg (10 ml/kg) body weight
- No. of animals per sex per dose:
- 3 animals/per sex/per dose (all groups received same dose level)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Twice daily observations for mortality/viability. Body weights were observed on Days 1, 8 and 15. Clinical signs were observed at periodic intervals on the day of dosing and once daily until day 15.
- Necropsy of survivors performed: Yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other - Statistics:
- No statistical analysis was performed, method not intended to develop a precise LD50.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality occured
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: other: OECD GHS and and EC criteria for classification and labeling requirements for dangerous substances and preparations.
- Conclusions:
- The oral LD50 value of the test article in Wistar rats was established to exceed 2000 mg/kg body weight. According to the OECD 423 test guideline the LD50 cut-off value was considered to exceed 5000 m/kg body weight. Based on these results, the test article does not have to be classified and has no obligatory labelling requirement for oral toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals of the United Nations and EC criteria for classification and labeling requirements for dangerous substances and preparations.
- Executive summary:
The acute oral toxicity of the test article was assessed in the rat using the Acute Toxic Class Method. The study followed guidelines from the OECD, no. 423, EC Council Directive 67/548/EEC, EPA OPPTS 870.1100 (2002) and JMAFF guidelines (2000) including the most recent partial revisions. The test article was administered by oral gavage to two subsequent groups of three female Wistar rats at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 15). No mortality occured in this study. Hunched posture was noted in one animal on day 1. No clinical signs were noted in the other animals. The mean body weight gain shown by the animals over the study period was considered to be normal. No abnormalities were found at macroscopic post mortem examination of the animals.The oral LD50 value of the test article in Wistar rats was established to exceed 2000 mg/kg body weight. According to the OECD 423 test guideline the LD50 cut-off value was considered to exceed 5000 m/kg body weight. Based on these results, the test article does not have to be classified and has no obligatory labelling requirement for oral toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals of the United Nations and EC criteria for classification and labeling requirements for dangerous substances and preparations.
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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