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EC number: 215-133-1 | CAS number: 1304-56-9
- 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: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well described study with clear endpoints that were addressed properly.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 984
Materials and methods
- Principles of method if other than guideline:
- Endotracheal injection of BeO to two strains of Guinea pigs.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Automatically generated during migration to IUCLID 6, no data available
- IUPAC Name:
- Automatically generated during migration to IUCLID 6, no data available
- Details on test material:
- BeO (from Brush Wellman). No further information
Constituent 1
Test animals
- Species:
- guinea pig
- Strain:
- other: Strain 2 and strain 13
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- 200-250g. Animals fed pellet diet supplemented by fresh cabbage.
Administration / exposure
- Route of administration:
- other: Endotracheal
- Vehicle:
- physiological saline
- Doses:
- 5 mg BeO in 1 ml physiological saline
- No. of animals per sex per dose:
- Depending on study.
N= 29/35 for investigation of Be-induced lung disease. - Control animals:
- yes
- Details on study design:
- Induction of lung disease:
Two strains of Guinea pigs were administered 5 mg of BeO per endotracheal. Animals were sacrificed after 2, 6, and 10 weeks after dosing. Lung tissue was examined histologically and for Be content. One group of animals was kept for 1.5 years to determine the long term effect of BeO exposure.
Immunization experiment:
Groups of animals received intradermal injection of 10 mg of BeO in saline and Freund's complete adjuvant. Animals were later skin tested by applying 5 ug of BeSO4 or MgSO4 (control) in saline to the skin of animals receiving intradermal injection and endotracheal administration.
The following assays were performed on lymph node cells: Lymphocyte stimulation assay, macrophage migration inhibition assay, fibroblast inhibition assay - Statistics:
- Student's T-test, Mann-Whitney test
Results and discussion
- Mortality:
- Half of strain 13 animals exposed to BeO did not survive until 1.5 years.
- Clinical signs:
- None reported/not assessed
- Body weight:
- No changes reported/assessed
- Other findings:
- Strain 2 but not strain 13 developed granulomatous lung disease by 6 weeks (please see table 1 below). After 1.5 years, the severity of lung disease in strain 2 was significantly reduced. There was a large degree of low grade granulomatous lung disease in the controls from strain 13 animals. Be was persistent in the lungs with significant amounts after 1.5 years (3500-19000 μg/100 g). Approximately half of strain 13 animals exposed to BeO did not survive after 1.5 years.
No evidence of neoplastic changes after 1.5 years.
Lymphocyte proliferation assay:
Spleens and lymph node cells from strain 2 animals exposed to BeO demonstrated significant uptake of tritiated thymidine. This effect was not seen in strain 13 animals exposed to BeO or in animals treated with latex.
Lymphokine assay:
Lymph node cells from strain 2 animals exposed to BeO produced significant migration inhibition factor activity. This effect was not seen in strain 13 animals exposed to BeO or in animals treated with latex.
Strain 2 animals showed an allergic reaction to beryllium but not magnesium salts after being skin-tested with ug BeSo4 (please see table 2 below). This effect was also seen in strain 2 x strain 13 F1 offspring.
Any other information on results incl. tables
Table 1 Granulomatous lung disease in strain 2 and strain 13 guinea pigs
Time after treatment | Strain 2 | Strain 13 | ||||
Animals affected | Median grade of disease | Animals affected | Median grade of disease | |||
n | % | |||||
Untreated | 3/24 | 12.5 | 0 | 2/23 | 8.7 | 0 |
2 weeks | 6/8 | 75.0 | 1 +* | 1/7 | 14.3 | 0 |
6 weeks | 16/17 | 94.1 | 2 -3 +** | 2/14 | 14.3 | 0 |
8 -10 weeks | 10/10 | 100.0 | 2 -3 +** | 3/8 | 37.5 | 0 |
*p<0.025
**p<0.001
Table 2 Skin test in strain 2 and 13
Type of BeO exposure | Number of animals | Mean diameter of skin reaction | ||
Strain 2 | Strain 13 | F1 ( 2 x 13) | ||
None | 6 | 1.3 +/-0.99 | 0 | 1.3 +/-1.31 |
Endotracheal | 5 | 7.8 +/-0.38** | 0 | 7.0 +/-1.13* |
Intradermal | 2 | 5.0 +/-1.0 | 0 | ND |
*p<0.05
**p<0.0001
Applicant's summary and conclusion
- Conclusions:
- This study confirmed previous observations of formation of granulomas in animals exposed to BeO. There is a large genetic component deciding the response to BeO in guinea pigs since effects of BeO was seen in 1/2 strains tested.
- Executive summary:
Strain 2 and strain 13 guinea pigs were administered BeO by endotracheal injection. Another group of animals received BeO by intradermal injection. The animals were observed at week 2, 6, and 10 for presence of lung disease. At the same timepoints spleens and lymph node cells (tracheobronchial) was removed and immunological parameters assessed in a lymphocyte stimulation assay, macrophage migration inhibition assay, and a fibroblast inhibition assay. Another group of animals were kept for 1.5 years and then evaluated for lung disease and neoplasms. Delayed skin hypersensitivity following exposure to BeSO4 and MgSO4 (control) was also determined.
Strain 2 animals demonstrated granulomatous lung disease after 6 weeks. There was also an effect on the immunological assays performed with reduced uptake of thymidine and migration inhibition in lymphocytes observed. Delayed skin hypersensitivity was also observed in this strain. These effects were not seen in strain 13 animals suggesting a genetic component to BeO response.
After 1.5 years there was no neoplasms observed in any of the exposed animals. The BeO concentration in lung tissue was still significant at this timepoint.
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