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

Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008-11-28 to 2009-07-31
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline-compliant study under GLP without deviations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
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 Powder
- Substance type: Metal
- Physical state: solid, powdered
- Analytical purity: 99.4 %
- Lot/batch No.: O-30 H grade/Blend # 051106
- Expiration date of the lot/batch: 2050-12-31
- Storage condition of test material: dry
The test item was extracted in 0.9 % saline for 72 h in the dark at 37 °C under non-abrasive conditions. Particulate matter was removed by centrifugation before incubation of the bacteria.
Constituent 1
Method
- Target gene:
- TA 1537 his C 3076; rfa-; uvrB-
TA 98 his D 3052; rfa-; uvrB-;R-factor
TA 1535 his G 46; rfa-; uvrB-
TA 100 his G 46; rfa-; uvrB-;R-factor
WP2 uvrA trp-; uvrA-
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- - Type and identity of media:
Precultures: 8 g Merck Nutrient Broth (MERCK, D-64293 Darmstadt), 5 g NaCl (MERCK, D-64293 Darmstadt)
Agar: 6.0 g MERCK Agar Agar
6.0 g NaCl
10.5 mg L-Histidine*HCl*H2O
12.2 mg Biotin
- Properly maintained: yes/no
- Periodically checked for Mycoplasma contamination: yes/no
- Periodically checked for karyotype stability: yes/no
- Periodically "cleansed" against high spontaneous background: yes/no
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S9 mix
- Test concentrations with justification for top dose:
- 2.5, 10, 20, 40, 60, 80, 100 % test item extract (see "Details on Test Material")
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: physiol. saline
- Justification for choice of solvent/vehicle: due to insolubility of beryllium metal in aqueous media at relevant pH for genotoxicity testing, extracts had to be prepared simulating lung conditions as the most relevant route of exposure
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- physiol. saline
- True negative controls:
- yes
- Remarks:
- untreated
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- Migrated to IUCLID6: and sodium azide; 2-aminoanthracene; 4-nitro-o-phenylene-diamine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation (Exp. I), in agar (plate incorporation; Exp. II);
DURATION
- Preincubation period: 60 min.
- Selection time (if incubation with a selection agent): 48 h
SELECTION AGENT (mutation assays): ready-made selection agar plates from Merck, suitable for the individual strains
NUMBER OF REPLICATIONS: 3 replicates for each strain and dose level, in each experiment
DETERMINATION OF CYTOTOXICITY
- Method: reduction in number of revertants - Evaluation criteria:
- A test item is considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA 98, TA 100, and WP2 uvrA) or thrice (strains TA 1535 and TA 1537) the colony count of the corresponding solvent control is observed (3).
A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration (2).
An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.
A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative and solvent controls such an increase is not considered biologically relevant. - Statistics:
- none applied
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1:Number of revertants per plate (mean of 3 plates); Experiment I
|
TA 1535 |
TA 1537 |
TA 98 |
||||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
15 |
19 |
n |
12 |
11 |
n |
125 |
140 |
n |
2.5 |
15 |
20 |
n |
10 |
10 |
n |
135 |
144 |
n |
5 |
16 |
16 |
n |
14 |
12 |
n |
126 |
139 |
n |
10 |
18 |
19 |
n |
12 |
12 |
n |
134 |
148 |
n |
20 |
16 |
17 |
n |
11 |
11 |
n |
115 |
132 |
n |
40 |
13 |
17 |
n |
10 |
13 |
n |
122 |
145 |
n |
60 |
15 |
18 |
n |
6 |
12 |
n |
132 |
141 |
n |
80 | 15 | 15 | n | 10 | 11 | n | 130 | 142 | n |
100 | 16 | 14 | n | 10 | 12 | n | 125 | 125 | n |
Positive control | 1998 | 373 | n | 83 | 258 | n | 2125 | 2418 | n |
|
TA 100 |
WP2 uvrA |
|||||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
|||
0* |
125 |
140 |
n |
58 |
60 |
n |
|
|
|
2.5 |
135 |
144 |
n |
65 |
66 |
n |
|
|
|
5 |
126 |
139 |
n |
63 |
67 |
n |
|
||
10 |
134 |
148 |
n |
62 |
68 |
n |
|
||
20 |
115 |
132 |
n |
59 |
65 |
n |
|
|
|
40 |
122 |
145 |
n |
57 |
58 |
n |
|
||
60 |
132 |
141 |
n |
67 |
61 |
n |
|
|
|
80 | 130 | 142 | n | 57 | 62 | n | |||
100 | 125 | 125 | n | 61 | 62 | n | |||
Positive control | 2125 | 2418 | n | 1492 | 181 | n |
*solvent control with 0.9% NaCl
Table 1:Number of revertants per plate (mean of 3 plates); Experiment II
|
TA 1535 |
TA 1537 |
TA 98 |
||||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
15 |
21 |
n |
17 |
19 |
n |
22 |
31 |
n |
10 |
11 |
19 |
n |
14 |
19 |
n |
24 |
34 |
n |
20 |
13 |
22 |
n |
15 |
14 |
n |
22 |
38 |
n |
40 |
14 |
15 |
n |
16 |
17 |
n |
25 |
36 |
n |
60 |
14 |
19 |
n |
15 |
17 |
n |
21 |
31 |
n |
80 | 13 | 20 | n | 12 | 18 | n | 19 | 31 | n |
100 | 17 | 19 | n | 19 | 18 | n | 20 | 34 | n |
Positive control | 1840 | 237 | n | 105 | 184 | n | 377 | 1324 | n |
|
TA 100 |
WP2 uvrA |
|||||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
|||
0* |
156 |
178 |
n |
52 |
53 |
n |
|
|
|
10 |
159 |
196 |
n |
55 |
64 |
n |
|
||
20 |
157 |
162 |
n |
58 |
56 |
n |
|
|
|
40 |
150 |
172 |
n |
53 |
61 |
n |
|
||
60 |
161 |
168 |
n |
47 |
55 |
n |
|
|
|
80 | 163 | 171 | n | 53 | 63 | n | |||
100 | 142 | 170 | n | 53 | 64 | n | |||
Positive control | 1906 | 1550 | n | 284 | 248 | n |
*solvent control with 0.9% NaCl
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
No genotoxic potentail of beryllium metal powder was identified in a bacterial reverse mutation assay in absence and presence of metabolic activation. - Executive summary:
The mutagenic potential of beryllium metal powder was investigated in an Ames test according to OECD guideline 471. Briefly, bacteria (S. typhimurium TA1535, TA1537, TA98, TA 100 and E. coli WP2 uvrA) were exposed to the test item in presence and absence of metabolic activation (rat liver S9) and grown on selective agar plates, eliminating bacteria without mutations. The colonies formed from surviving (= mutant) bacteria were counted.
Beryllium metal was - due to its insolubility in aqueous media at neutral pH - extracted in physiological saline and the extracts were applied to expose the bacteria. In the first expereiment the pre-incubation and in the second experiment the plate incorporation method were used.
No increases of mutant numbers were observed in treated groups compared to control. The test item was non-mutagenic in the bacterial reverse mutation assay under the test conditions.
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.
