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EC number: 480-240-4 | CAS number: 185257-07-2
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Principles of method if other than guideline:
- Acute toxic class method (ATC method) by E. Schlede, U. Mischke, R. Roll, D. Kayser: A national validation study of the acute toxic class method - an alternative to the LD50 test. Arch. Toxicol. 66: 455-470 (1992).
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): MGDN
- Substance type: powder
- Physical state: solid
- Analytical purity: 97.9 %
- Lot/batch No.: GRE 3038/F 535
- Storage condition of test material: room temperature
Test animals
- Species:
- rat
- Strain:
- other: Wistar CHBB: THOM (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: DR. K. THOMAE GMBH, BIBERACH, FRG
- Age at study initiation: YOUNG ADULT ANIMALS.
- Weight at study initiation: ANIMALS OF COMPARABLE WEIGHT; (150G - 300G); (+- 20% OF THE MEAN WEIGHT)
- Fasting period before study: THE ANIMALS WERE GIVEN NO FEED AT LEAST 16 HOURS BEFORE ADMINISTRATION, BUT WATER WAS AVAILABLE AD LIBITUM.
- Housing: SINGLE HOUSING.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: ACCLIMATIZATION FOR AT LEAST 1 WEEK.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 -24 DEGREES CELSIUS
- Humidity (%): 30 -70 % FOR RELATIVE HUMIDITY
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.25 G/100 ML (25 mg/kg bw) or 2 G/100 ML (200 mg/kg bw)
- Amount of vehicle (if gavage): 10 ML/KG
- Justification for choice of vehicle: AQUEOUS FORMULATION CORRESPONDS TO THE PHYSIOLOGICAL MEDIUM
MAXIMUM DOSE VOLUME APPLIED: 10 ML/KG
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: no data - Doses:
- 25 mg/kg and 200 mg/kg
- No. of animals per sex per dose:
- 3 males/3 females at 25 mg/kg bw and 3 males at 200 mg/kg bw
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: INDIVIDUAL BODY WEIGHTS SHORTLY BEFORE APPLICATION (DAY 0), WEEKLY THEREAFTER AND AT THE END
0F THE STUDY (BEFORE FASTING PERIOD). RECORDING 0F SIGNS AND SYMPTOMS SEVERAL TIMES ON THE DAY OF ADMINISTRATION, AT LEAST ONCE EACH WORKDAY FOR THE INDIVIDUAL ANIMALS. A CHECK FOR ANY DEAD OR MORIBUND ANIMAL WAS MADE TWICE EACH WORKDAY AND ONCE ON SATURDAYS, SUNDAYS AND ON PUBLIC HOLIDAYS.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
NECROPSY AT THE LAST DAY OF THE OBSERVATION PERIOD. WITHDRAWAL OF FOOD AT LEAST 16 HOURS BEFORE KILLING WITH C02; THEN NECROPSY WITH GROSSPATHOLOGY EXAMINATION. NECROPSY OF ALL ANIMALS THAT DIED BEFORE AS EARLY AS POSSIBLE. - Statistics:
- not applicable
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- other: Median lethal dose
- Effect level:
- > 25 - <= 200 mg/kg bw
- Mortality:
- Dose 1 (25 mg/kg): no mortality.
Dose 2 (200 mg/kg): all three male animals died within 2 hours. - Clinical signs:
- Animals from the low dose group showed no clinical signs.
All animals of the high dose group suffered from: Poor general state, dyspnoea, apathy, ataxia, tremor and twitching within two hours after treatment. 2 animals showed piloerection after 1 hour. 1 animal showed salivation after 1 hour. - Body weight:
- see table 1: Remarks on results.
- Gross pathology:
- Sacrificed animals (3 male/3 female): no pathologic findings noted.
Animals that died (3 male): agonal congestion.
Any other information on results incl. tables
Table 1: Mean body weights
Mean body weight |
male |
female |
||
25 mg/kg |
200 mg/kg |
25 mg/kg |
||
day 0 |
227 |
188 |
187 |
|
day 7 |
286 |
228 |
||
day 13 | 315 | 241 |
Applicant's summary and conclusion
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.