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Toxicological information

Acute Toxicity: oral

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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:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no information

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
5 per sex

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
single dose by oral gavage in water and observed for 14 days
Doses:
single dose of 5 gZnO/kg bw
No. of animals per sex per dose:
5 per sex
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:
> 5 000 mg/kg bw
Mortality:
no mortality
Clinical signs:
no adverse signs of toxicity
Body weight:
no adverse signs of toxicity
Gross pathology:
no adverse signs of toxicity

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 > 5000 mg ZnO/kg bw was determined.
Executive summary:

In an acute toxicity test Wistar rats (5/sex) were given a single dose of 5 g ZnO/kg bw (in water) by gavage and observed for 14 days. No mortality and signs of toxicity were observed. The LD50for rats is therefore >5 g ZnO/kg bw.