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EC number: 428-970-4 | CAS number: 13595-25-0
- 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:
- 19 February to 25 March 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been QA audited and has been conducted in the spirit of GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Bisphenol-M
- IUPAC Name:
- Bisphenol-M
- Details on test material:
- - Name of test material (as cited in study report): Bisphenol-M
- Substance type: Monomer
- Physical state: Fine white crystals
- Analytical purity: 99.5%
- Lot/batch No.: 5426
- Storage conditions: Ambient temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Laboratory supplier
- Age at study initiation: About 5 weeks old.
- Weight at study initiation: Males, 93 - 142 g and females, 84 - 133 g.
- Fasting period before study: Food removed 18 h before administration of test substnace.
- Housing: Type RC1 cages consisting of a high density polypropylene body with a stainless steel grid floor.
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: At least 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 55
- Air changes (per hr): 17
- Photoperiod: 12 h light / 12 h dark
IN-LIFE DATES: From: To:
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% w/v Methylcellulose in distilled water.
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: Volume - dosage of 20 ml/kg. - Doses:
- 3162, 3976, 5000 and 6288 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: 0900 h, 1200 h and 1600 h daily except weekends when two inspections were made each day.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macropathology,
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 6 095 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 4 915 - 7 274
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 5 465 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 4 514 - 6 416
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 7 443 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 2 928 - 11 957
- Mortality:
- Male: 3162 mg/kg bw; Number of animals: 5; Number of deaths: 0
Male: 3976 mg/kg bw; Number of animals: 5; Number of deaths: 0
Male: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 3
Male: 6288 mg/kg bw; Number of animals: 5; Number of deaths: 3
Female: 3162 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 3976 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 2
Female: 6288 mg/kg bw; Number of animals: 5; Number of deaths: 1 - Clinical signs:
- other: Signs of toxicity related to dose levels: Main symptoms were reduction of motor activity, ataxia, diarrhoea, piloerection and neglected fur. Most of the surviving animals recovered on day 2 of the observation, although the neglected appearance lasted
- Gross pathology:
- Effects on organs: Common findings including spotted fur, abnormal content of the gastro-intestinal-tract, stomach expansion and dark lungs. In single cases adhesions between the lungs and the diaphragm and further liquid accumulation in the thorax region, dark adrenal gland and thin hair were found.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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