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Diss Factsheets
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EC number: 404-170-0 | CAS number: 70750-63-9
- 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:
- 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study; well documented study report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V
- Deviations:
- yes
- Remarks:
- In the report the first day of the treatment is noted as day 1 instead of day 0 due to changed procedures; all animals were provided with tap-water and not with tap-water diluted with decalcified water as per protocol
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- yes
- Remarks:
- In the report the first day of the treatment is noted as day 1 instead of day 0 due to changed procedures; all animals were provided with tap-water and not with tap-water diluted with decalcified water as per protocol
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Details on test material:
- - Molecular formula (if other than submission substance): NDA
- Molecular weight (if other than submission substance): NDA
- Smiles notation (if other than submission substance): NDA
- Substance type: NDA
- Physical state: Blue powder
- Analytical purity: NDA
- Impurities (identity and concentrations): NDA
- Composition of test material, percentage of components: NDA
- Isomers composition: NDA
- Purity: 100% - moisture
- Lot/batch No.: Ref Mix 51785
- Expiration date of the lot/batch: NDA
- Stability under test conditions: Stable under storage conditions
- Storage condition of test material: At room temperature in the dark
- Other: Disposal category III
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 Wiga. Sulzfeld, West-Germany
-Age at study initiation: approx. 7 weeks
-Weight at study initiation: males: 230~249 g; females: 158~171 g.
-Fasting period before study: Feed was withheld overnight prior to dosing until approximately 3-4 h after administration of the test article.
-Housing: housed in groups of 5 per sex in polycarbonate cages containing purified sawdust as bedding material.
-Diet: free access to standard pelleted laboratory animal diet (RMH-B from Hope Farms, The Netherlannds)
-Water: free access to tap-water.
-Acclimation period: at least 5 days under laboratory conditions.
ENVIRONMENTAL CONDITIONS
-Temperature (°C): 21± 3 oC
-Humidity (%): 30-70%
-Air changes: 7.5 – 15 air changes per hr
-Photoperiod (12 hrs dark /12 hrs light)
IN-LIFE DATES: From: Jan 5th 1989 To: Jan 19th 1989
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 500 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg bw
- Justification for choice of vehicle: NA
- Lot/batch no. (if required): NA
- Purity: NA
MAXIMUM DOSE VOLUME APPLIED:
DOSAGE PREPARATION (if unusual): NA
CLASS METHOD (if applicable) NA
- Rationale for the selection of the starting dose: NDA - Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5/ses/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: on the day of dosing (Day1) and twice daily for at least 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- Using the mortality data obtained, an estimate of the acute oral median lethal dose (LD50) of the test material was made.
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- Male: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other: No deaths occurred and no clinical signs of toxicity or behavioral changes were observed
- Gross pathology:
- No treatment-related macroscopic findings were observed via microscopic examination for all animals at termination.
- Other findings:
- - Organ weights: NDA
- Histopathology: NDA
- Potential target organs: NDA
- Other observations: NDA
Any other information on results incl. tables
The information contained in this robust summary may not be published, broadcast, rewritten or otherwise distributed without the prior written authority of the owner of the study.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EEC Directive 83/467/EEC, Annex VI of the EEC Directive 67/548/EEC
- Conclusions:
- The acute oral median lethal dose (LD50) of the test material in the Wistar strain, outbred Albino rats was found to be greater than 5000 mg/kg bodyweight. The test substance was classified as non-toxic.
- Executive summary:
In an acute oral toxicity study, 2 groups fasted 7 week old Wistar strain,outbred Albino rats(five male and five female) were given a single oral dose of the test material in water a dose level of 5000 mg/kg bw and observed for14 days. No mortality occurred. No signs of systemic toxicity, or behavioral changes were noted during the study, and no abnormalities were noted at necropsy.All animals showed expected bodyweight gain during the study. The oral LD50 value of the test material in rats of both sexes was stimulated to exceed 5000 mg/kg bw.
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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