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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
Additional toxicological data
Administrative data
- Endpoint:
- additional toxicological information
- Type of information:
- other: review of available experimental toxicity results
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Review based on reliable studies performed according to the respective OECD Guidelines
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 010
Materials and methods
- Type of study / information:
- The author presents a review of reliable acute, local and genotoxicity testing results for beryllium metal powder generated pursuant to REACH.
- Principles of method if other than guideline:
- All reported studies were performed, when available, according to the respective OECD guidelines:
Acute oral toxicity: OECD423
Skin irritation: OECD 404
Eye irritation: OECD 405
Skin sensitization: OECD 406
Ames-Test: OECD 471
Mammalian cell gen mutation: OECD 476
Mammalian cell chromosome aberration: OECD 473
Unscheduled DNA repair synthesis: OECD 483
Cell transformation: Commission Regulation (EC) No. 440/2008 B.21
Ion formation under simulated lung conditions: no guideline available
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
- Test material form:
- other: solid
- Details on test material:
- - Name of test material (as cited in study report): beryllium
- Substance type: metal
- Physical state: solid
Constituent 1
Results and discussion
Any other information on results incl. tables
For detailed results see tables in the attached document.
Acute oral toxicity:
No mortality occurred during the study. No clinical signs related to the administration of the test item were observed. The body weight evolution of the animals remained normal throughout the study. The macroscopical examination of the animals at the end of the study did not reveal any indication of toxicity (table 1 of attached document).
Skin irritation:
No signs of skin irritation was observed at any time point of the study. All animals survived and showed no signs of toxicity or effects on body weight gain (table 2 of attached document).
Eye irritation
Slight initial chemosis and slight to moderate redness of the conjunctiva were observed in all animals. Redness of the conjunctivae was observed until 72 h after administration, and thus animals were observed again after 7 days, by when the redness had completely resolved in all animals (table 3 of attached document).
Skin sensitization
Animals showed no signs of skin reations after challenge exposure. No mortality occurred during the study. No clinical signs related to the test item were observed. The body weight evolution of the animals remained normal throughout the study (table 4 of attached document).
Ion formation
The solubility of beryllium metal differed significantly from the solubility of beryllium chloride, especially under conditions of neutral pH. The percentage of beryllium ions dissolved from metal was found to be factor 3–40 lower than from beryllium chloride. Dissolution kinetics of beryllium metal and beryllium chloride were found to be too different to conduct the in vitro tests with beryllium chloride. Therefore, the genotoxicity experiments were performed with metal extracts (in 0.9% NaCl for Ames-Test and in culture medium for mammalian cell gene mutation/mammalian cell chromosome aberration/UDS/cell transformation) (table 5 of attached document).
Ames-Test
Beryllium metal was tested negativ with and without metabolic activation in two independent experiments (table 6 of attached document).
Mammalian cell gene mutation
Beryllium metal was found not mutagenic with and without metabolic activation (table 7 of attached document).
Chromosome aberration in mammalian cells
No genotoxic potential was identified for beryllium metal neither in the presence or absence of metabolic activation. A single significant increase in the number of aberrant cells upon long-term treatment without metabolic activation is considered treatment related since no dose-response relation was observed and this effect was not observed in parallel experiments (table 8 of attached document).
Mammalian cell unscheduled DNA repair synthesis (UDS test)
Beryllium metal did not induce DNA repair synthesis in the UDS assay, therefore it is not considered as having damaged the DNA. In addition no cytotoxicity was observed. In pre-damaged cells where 96 % cells were in repair synthesis (addition of 2.23 µg/ml 2 -acetylaminofluorene) an effect on DNA was observed. In a repeat experiment DNA damage was high in all concentrations of
2 -acetylaminofluorene, but no cytotoxicity was observed. In conclusion, no direct effect of beryllium metal extracts was detected (table 9 -11 of attached document).
Cell transformation
All tested concentrations of beryllium metal extract showed increased transformation rates compared to control (table 12 of attached document).
Overview on experimental results with beryllium metal
Study |
Species or type |
Result |
Acute oral toxicity |
Rat |
LD50 > 2000 mg kg-1 b.w. |
Skin irritation |
Rabbit |
No signs of skin irritation at any time point. |
Eye irritation |
Rabbit |
Slight initial conjunctival redness, fully reversible within 7 days. No effects on cornea or iris. |
Skin sensitization (maximization method) |
Guinea Pig |
Not sensitizing. |
Bacterial gene mutation (Ames-Test) |
Salmonella typhimurium/ Escherichia coli |
Negative |
Mammalian cell gene mutation |
V79 cell line (in vitro) |
Negative |
Mammalian cell chromosome aberration |
Human lymphocytes (in vitro) |
Negative |
Mammalian cell unscheduled DNA repair synthesis (UDS test) |
Rat primary hepatocytes (in vitro) |
Negative (beryllium exposure only); indication of reduced repair of hepatocytes with damaged DNA |
Cell transformation (SHE assay) |
SHE cells (in vitro) |
Positive |
Applicant's summary and conclusion
- Conclusions:
- No relevant acute oral toxicity, low local irritating properties and no skin sensitizing properties were found for beryllium metal powder.
The genotoxicity tests conducted in vitro, covering gene mutation, chromosome aberration, DNA repair and its inhibition, did not reveal any genotoxic potential for beryllium metal when extracted under simulated lung conditions. No signs of DNA repair as a measure of direct DNA damage, no gene mutation or clastogenicity were observed. Based on these test results, beryllium metal is not a mutagen, clastogen or DNA damager. Beryllium metal extracts did reduce DNA repair of rat hepatocytes that were severely damaged by external stimulus, while no effects were observed in slight or moderately damaged cells. This finding is in agreement with a publication on a soluble beryllium compound. Due to absence of effects at slight or moderate DNA damage (up to doses leading to 50% of the treated cells initiating DNA repair), relevance to human toxicity is considered rather low because the general, as well as the occupationally exposed, population does not have a high degree of background DNA damage. It is recognized that the in vitro systems used in testing have limitations with respect to quantitative assessment. These test results suggest that even if beryllium is considered to be a carcinogen - based upon the weak associations of the past - it clearly exhibits no non-threshold effects. - Executive summary:
A review of newly conducted experimental studies with beryllium metal powder on acute oral toxicity, local skin and eye effects and genotoxicity performed according to the respective OECD Guidelines is given by Strupp.
The author concludes:
"The toxicity of soluble metal compounds is often different from that of the parent metal. Since no reliable data on acute toxicity, local effects, and mutagenicity of beryllium metal have ever been generated, beryllium metal powder was tested according to the respective Organisation for Economical Co-Operation and Development (OECD) guidelines. Acute oral toxicity of beryllium metal was investigated in rats and local effects on skin and eye in rabbits. Skin-sensitizing properties were investigated in guinea pigs (maximization method). Basic knowledge about systemic bioavailability is important for the design of genotoxicity tests on poorly soluble substances. Therefore, it was necessary to experimentally compare the capacities of beryllium chloride and beryllium metal to form ions under simulated human lung conditions. Solubility of beryllium metal in artificial lung fluid was low, while solubility in artificial lysosomal fluid was moderate. Beryllium chloride dissolution kinetics were largely different, and thus, metal extracts were used in the in vitro genotoxicity tests. Genotoxicity was investigated in vitro in a bacterial reverse mutagenicity assay, a mammalian cell gene mutation assay, a mammalian cell chromosome aberration assay, and an unscheduled DNA synthesis (UDS) assay. In addition, cell transformation was tested in a Syrian hamster embryo cell assay, and potential inhibition of DNA repair was tested by modification of the UDS assay. Beryllium metal was found not to be mutagenic or clastogenic based on the experimental in vitro results. Furthermore, treatment with beryllium metal extracts did not induce DNA repair synthesis, indicative of no DNA-damaging potential of beryllium metal. A cell-transforming potential and a tendency to inhibit DNA repair when the cell is severely damaged by an external stimulus were observed. Beryllium metal was also found not to be a skin or eye irritant, not to be a skin sensitizer, and not to have relevant acute oral toxic properties."
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