Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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EC number: - | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Used in EU risk assessment for zinc oxide, limited study details provided
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 972
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Zinc oxide
- EC Number:
- 215-222-5
- EC Name:
- Zinc oxide
- Cas Number:
- 1314-13-2
- Molecular formula:
- OZn
- IUPAC Name:
- oxozinc
- Details on test material:
- no information
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- no information
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- single dose by oral gavage and observed for 14 days
- Doses:
- single dose of 15 gZnO/kg bw
- No. of animals per sex per dose:
- 10 males
- Control animals:
- not specified
- Details on study design:
- no further information
- Statistics:
- no data
Results and discussion
- Preliminary study:
- no further information
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 15 000 mg/kg bw
- Mortality:
- no mortality
- Clinical signs:
- other: ruffled fur
- Gross pathology:
- no adverse signs of toxicity
- Other findings:
- none
Any other information on results incl. tables
none
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- LD50 >15,000 mg ZnO/kg bw was determined.
- Executive summary:
In an acute oral study, ten male Wistar rats received a single dose of 15 g ZnO/kg bw by gavage. No mortality occurred. Signs of toxicity were ruffled fur, decreased body weights and diarrhoea. The LD50value for rats was >15 g ZnO/kg bw. No furher information available.
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.
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