Registration Dossier
Registration Dossier
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EC number: 231-175-3 | CAS number: 7440-66-6
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:
- guideline study with acceptable restrictions
- Remarks:
- used in EU risk assessment report for Zinc metal
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Zinc
- EC Number:
- 231-175-3
- EC Name:
- Zinc
- Cas Number:
- 7440-66-6
- Molecular formula:
- Zn
- IUPAC Name:
- zinc
- Details on test material:
- - Name of test material (as cited in study report): Zincstaub, superfein 620
- Other: Zinc powder particle diameter was 5 micrometer
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- no further details provided
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- maize oil
- Details on oral exposure:
- In this study very fine zinc powder, labelled as “Zincstaub, superfein 620”, was given as a suspension in maize oil
- Doses:
- one dose of 2000 mg zinc/kg bw
- No. of animals per sex per dose:
- no data
- Control animals:
- not specified
- Details on study design:
- no further information
- Statistics:
- no information
Results and discussion
- Preliminary study:
- no information
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- no mortality observed
- Clinical signs:
- other: piloerection in all females, diarrhoea in one female
- Gross pathology:
- no adverse effects reported
- Other findings:
- none
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50 >2000 mg/kg bw
- Executive summary:
A limit study with Wistar rats was carried out according to OECD guideline no. 401 to assess the oral LD50. Apart from piloerection in all females and diarrhoea in one female, no mortality or clinical signs were observed after dosing of 2000 mg zinc/kg bw during the 14 day observation period. In this study very fine zinc powder, labelled as “Zincstaub, superfein 620”, was given as a suspension in maize oil. The particle size was not given in this study, but according to the accompanying letter from the industry the particle diameter was 5 μm. An LD50-value of > 2000 mg/kg bw was reported
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