Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 231-150-7 | CAS number: 7440-41-7
- 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: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well-documented study with clear scope. Tailor-made for the purpose. Non-GLP, not following guideline.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 990
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Single exposure of rats during 50 minutes to Berylliummetal followed by investigation period over 171 days.
- GLP compliance:
- not specified
- Test type:
- other:
- Limit test:
- no
Test material
- Reference substance name:
- Beryllium
- EC Number:
- 231-150-7
- EC Name:
- Beryllium
- Cas Number:
- 7440-41-7
- Molecular formula:
- Be
- IUPAC Name:
- beryllium
- Details on test material:
- - Name of test material (as cited in study report): Beryllium metal
- Substance type: metal
- Physical state: solid
- Analytical purity: not repored
- Lot/batch No.: from stock batch of metal particles (Type I-400) prepared by Brush-Wellman Co. (Elmore, OH)
- Expiration date of the lot/batch: not reported
- Stability under test conditions: assumed to be stable
- Storage condition of test material: not reported
Constituent 1
Test animals
- Species:
- rat
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Lovelace Inhalation Toxicology Research Institute Breeding colony
- Age at study initiation: 11 - 13 weeks
- Fasting period before study: none
- Housing: filter topped polycarbonate cages lined with hardwood chip bedding
- Diet : not reported, assumed ad libitum
- Water :not reported, assumed ad libitum
- Acclimation period: not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): not reported
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported
IN-LIFE DATES: not reported
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: "Lovelace 96-port nose only chamber"
- Exposure chamber volume: not reported
- Method of holding animals in test chamber: single
- Source and rate of air: 24 l/min
- Method of conditioning air: not reported
- System of generating particulates/aerosols: ball milled metal paricles were passed into a dry powder mill, then passed through single stage cyclone to remove larg particle fraction
- Method of particle size determination: cascade impactor
- Treatment of exhaust air: not reported
- Temperature, humidity, pressure in air chamber: not reported
TEST ATMOSPHERE
- Brief description of analytical method used: continuous air monitor (PCAM; ppm, Inc., Knoxville TN), filterpaper weighing
- Samples taken from breathing zone: yes (assumed)
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: (50 % effective cutoff diameter of cyclone = 1.7 micrometer)
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 1.4 +/- 0.1 µm/ 1.9 +/- 0.1 µm - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- assumed, not reported in publication
- Duration of exposure:
- 50 min
- Concentrations:
- 800 mg/cubicmeter, resulting in 625 µg Be metal per rat
- No. of animals per sex per dose:
- Total of 74 male rats, divided into groups of 6 per sacrifice time point
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 171 days
- Frequency of observations and weighing: days 3, 7, 10, 14, 31, 59, 115, 171
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, lung weights, macropathology, histopathology, other: Broncho-alveolar lavage (differntial cells, total protein, beta-glucuronidase, LDH, Beryllium burden - Statistics:
- Treated animals vs. controls: two-way analysis of variance (Neter 1985)
Each endpoint and contrast (8 time-point) F distribution at p= 0.05 and p= 0.01
Results and discussion
Effect levels
- Dose descriptor:
- LC50
- Remarks on result:
- not determinable
- Mortality:
- 20 animals died spontaneously between days 12 and 15 post exposure.
- Clinical signs:
- other: All exposed animals were lethargic and had increased respiratory rates from day 3 to 14 post exposure. After day 31, all appeared clinically normal.
- Body weight:
- Not reported
- Gross pathology:
- Lungs after 3 days: diffusely tan to grey, collaps poorly.
Lungs after 7, 10, 14 days: increasingly dark brown, mottled with bright red areas. At 14 d wet & heavy, do not collaps.
Lungs after 31 days: only mildly mottled and grey, collaps well.
Lungs after 59 days: Multiple pales, small soft raised foci scattered throughout parenchyma and pleural surface.
Lungs after 115 days: foci increased in size,
Lungs after 1717 days: Foci large and confluent, lungs firm.
Tracheobroncial lymph nodes: mildly enlarged after 10 days, markedly enlarged and dark grey from day 59 to 171.
Control animals had no macroscopic changes at any time point.
Any other information on results incl. tables
- Lung weight development
- Microscopical lesions
- Differential cell counts
- Total protein, LDH and beta-glucuronidase
- Beryllium clearance from lung
For
see attached document.
Applicant's summary and conclusion
- Conclusions:
- In rats the lesions induced by beryllium inhalation appear to be due to direct chemical toxicity and foreign-body type reactions.
- Executive summary:
Rats were exposed to an aerosol of metallic Beryllium once during 50 minutes at a concentration of 800 mg/m3, (= 625 mg/rat) and followed up for 171 days. At the sacrifices after 3, 7, 10, 14, 31, 59, 115 and 171 days the investgated parameters were weight, macro- and micropathology of lungs, bronchoalveolar lavage (BAL) for cytology and enzymes and Be contents and clearance.
The treatment induced an increase in lung weight, acute necrotizing, haemorrhagic, exudative pneuminitis and intraalveolar fibrosis that peaked after 14 days. After 31 days, the inflammatory lesions had regressed to be replaced by minimal interstitial and intraalveolar fibrosis. Necrotizing inflammation reappeared after 59 days and progressed to chronic active inflammation after 115 days and worsened progressively, as did alveolar macrophage and epithelial hyperplasia, being severe after 171 days. Few diffusely distributed lymphocytes were present, but not associated with granulomas. In the BAL cells were elevated, mainly due to neutrophils. Lymphocytes were not increased. LDH, beta-glucuronidase and total protein levels were elevated up to day 14, and normal again at day 31. Only LDH was substantially increased again at day 59 and later. The Be-clearance was estimated to have a half life of about 240 days.
The results indicate that inhalation of beryllium metal by rats result in severe, acute chemical pneumonitis that is followed by a quiescent period of minimal inflammation and mild fibrosis. Progressive, chronic-active, fibrosing pneumonitis is observed later. The lesions appear to be due to direct chemical toxicity and foreign-body type reactions.
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.
