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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Relatively well described study with relevant endpoints and significant statistical material. Limited description of analytical section but references to studies are provided
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 975
Materials and methods
- Principles of method if other than guideline:
- Intratracheal administation of BeO to rats and impact of reproduction and onset of beryllium disease
- 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:
- Radioactively labelled BeO (7BeO) calcined at either 960 °C or 500 °C.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- Rats weighed between 150-200 g. Standard rat food was available during the study. Animals were weighed weekly.
Animals number:
First study: 120 females and 30 males
Second study: 40 females and 16 males
Administration / exposure
- Route of administration:
- intratracheal
- Vehicle:
- physiological saline
- Details on exposure:
- First study: 0.2 mg 7BeO in 0.2 ml
Second study: same dose and volume as first study - Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- Half of the females in each group were placed with males.; 4-5F and 2M per cage.
- Duration of treatment / exposure:
- Single exposure
- Frequency of treatment:
- Single exposure
- Duration of test:
- Final sacrifice 15 months after exposure
- No. of animals per sex per dose:
- BeO
Study 1: 80F and 15M
Study 2: 20F and 8M
An equivalent number of animals received saline only. - Details on study design:
- The number of dead and live pups were counted and the lactation index calculated. Animals were sacrificed at certain timepoints and tissues were taken for histological examination. Additionally, serum activity of alkaline phosphatase, isocitric dehydrogenase, glutamic pyruvic transaminase, lactic dehydrogenase, and concentration of serum calcium, cholesterol, glucose were determined.
Examinations
- Maternal examinations:
- Body weight
- Ovaries and uterine content:
- No information
- Fetal examinations:
- Whole fetus counted for 7BeO.
- Statistics:
- Fischer-Baron test for statistical comparisons
- Indices:
- Lactation index
- Historical control data:
- No information
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Lung lesions including bronchial mucosal hyperplasia and granulomata. Pregnancy had no effect on severity or time of onset. Renal calcificiation was also observed.
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
Teratogenic effects not properly assessed. Bodyweight of pups were not affected by maternal BeO exposure.No effects on reproductive parameters was observed except a slight increase in number of live pups and number of litters per female in Be exposed animals.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Concentration of Be in tissue was highest in lung. There was no significant effect of BeO on the biochemical parameters studied.
Table 1 Effect on reproductive parameters
Study 1 | # females | # pregnancies/female | #live pups/litter | #dead pups/litter | #live pups per female | Lactation index | Weight per pup |
12 mo sacrifice: Be | 5 | 4.6+/-0.7 | 10.0+/- 0.7 | 0.3 | 46.0+/-10.7 | 93.5 | 38.0 |
12 mo sacrifice: Saline | 4 | 3.5+/-0.6 | 9.9+/- 0.9 | 0.7 | 34.8+/-9.1 | 86.3 | 39.7 |
15 mo sacrifice: Be | 8 | 7.3+/-0.7 | 9.4+/-0.5 | 0.6 | 68.5+/- 7.7 | 82.9 | 40.6 |
15 mo sacrifice: Saline | 4 | 4.3+/-0.6 | 10.2+/- 0.9 | 0.8 | 43.5+/-7.9 | 83.3 | 39.8 |
Study 2 | |||||||
Be | 10 | 4.6+/-0.7 | 9.4+/-0.6 | 0.8 | 43.2+/-8.6 | 54.1 | 41.9 |
Saline | 10 | 4.0+/-0.5 | 7.1+/-0.6 | 0.9 | 27.8+/-5.7 | 80.0 | 42.3 |
Applicant's summary and conclusion
- Conclusions:
- The most significant observation in this study was the confirmation of lung granulomas in animals exposed to BeO. The other effects of BeO in this study is relatively modest and of relatively little relevance to humans. No effect on reproductive effects or onset of Beryllium disease were seen.
- Executive summary:
Male and female rats were administered radioactively labeled BeO. The animals were given a single dose of BeO via the intratracheal route. The animals were then allowed to breed repeatedly and then killed at various timepoints. Lung histology, level of Be in different tissues and various biochemical parameters were then assessed. Additionally, reproductive parameters were also assessed.
Lung lesions were observed in exposed animals. These were limited to granulomata and bronchial mucosal hyperplasia. Pregnancies had no effect on the onset or severity of these lesions. Renal calcification was also observed in some animals. No significant effect on reproductive parameters were seen.
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