Registration Dossier
Registration Dossier
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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010-09-15 to 2009-11-12
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according to OECD 423 guideline and performed under GLP conditions. No deviations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
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:
- -Beryllium Metal Powder
-Dark grey powder
-Batch number: 0-30 H grade/Blend #051106
-Purity: 99.4 %
-Stability: Stable under storage conditions
-Expiry date: 31 December 2050
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: RccHan: WIST (SPF)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories, Netherlands
- Age at study initiation: 10 weeks
- Weight at study initiation: 173.6-195.4g
- Fasting period before study: Overnight before dose and 3-4 hours post dose
- Housing: Makrolon type-4 cage with wire mesh tops and standard softwood bedding
- Diet (e.g. ad libitum): Provimi Kliba 3433
- Water (e.g. ad libitum):Tap water (bacteriological, chemical and contaminant analyses are archived with Harlan Laboratories)
- Acclimation period: Period not stated. Only animals without visible signs of illness were used
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3 C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15/hour
- Photoperiod (hrs dark / hrs light): 12 light/12 dark
IN-LIFE DATES: From: 23-09-2009 To: 15-10-2009
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- A single dose was administered per oral gavage after fasting for 17-19 hours. Dosing volume was 10 ml/kg bodyweight.
- Doses:
- 2000 mg/kg bodyweight
- No. of animals per sex per dose:
- 6
- Details on study design:
- Study was done according to OECD guideline 423. Two groups of 3 female animals each were administerd Beryllium metal in PEG-300 at a dose of 2000 mg/kg bodyweight. Animals were examined for clinical signs within the first 30 minutes of administration and then at 1, 2, 3, and 5 hours on the the same day. The animals were then observed twice daily from day 2-15. Bodyweight was recorded on day 1 (before administration) and then on day 8 and 15. Animals were subject to necropsy following at the termination of the study.
- Statistics:
- No statistical analysis performed.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality was observed
- Clinical signs:
- other: No clinical signs were observed
- Gross pathology:
- No macroscopic findings were recorded at necropsy
- Other findings:
- Feces was stained gray the day after application
Any other information on results incl. tables
Table 1 Mortality
| Dose level | Group | Animal number | Mortality |
| 2000 mg/kg bodyweight | 1 | 1 -3 | 0 |
| 2000 mg/kg bodyweight | 2 | 4 -6 | 0 |
Table 2 Bodyweight
| Group | Animal | Day 1 | Day 8 | Day 15 |
| Group 1 | 1 | 183.9 | 206.8 | 228.3 |
| 2 | 190.8 | 208.5 | 219.6 | |
| 3 | 195.4 | 211.2 | 220.6 | |
| Mean | 190.0 | 208.8 | 222.8 | |
| S.D. | 5.8 | 2.2 | 4.8 | |
| N | 3 | 3 | 3 | |
| Group 2 | 4 | 188.4 | 213.9 | 225.9 |
| 5 | 173.6 | 188.4 | 201.8 | |
| 6 | 182.3 | 205.6 | 215.4 | |
| Mean | 181.4 | 202.6 | 214.4 | |
| S.D. | 7.4 | 13.0 | 12.1 | |
| N | 3 | 3 | 3 | |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information LD50 > 2000 mg/kg bodyweight Criteria used for interpretation of results: EU
- Conclusions:
- The median lethal dose of beryllium metal powder after single oral administration to female rats is greater than 2000 mg/kg bodyweight.
- Executive summary:
Two groups of female rats (2 x 3 animals) were administered a dose of 2000 mg/kg bodyweight of beryllium metal powder in polyethylene glycol 300. The animals were examined during the first 30 minutes after administration and then at 1, 2, 3, 5 hours. From day 2 -15 the animals were observed twice daily. Bodyweight was recorded at the day of the study (before administration) and then on day 8 and 15. The animals were then subject to necropsy at the end of the study.
No mortality was observed. There were no clinical signs reported and bodyweight was within the range of what is normal for this strain and age. Necropsy did not reveal any significant findings. The LD50 of beryllium metal powder is > 2000 mg/kg bodyweight.
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.
