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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: used in EU risk assessment for zinc oxide, guideline study, reliable with restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Aerosol concentration was 5.7 mg/l and the particle size distribution had a mass median aerodynamic diameter of 4 m ± 2.9 (GSD)

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
no information available

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
nose/head only
Vehicle:
other: no data
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
ca. 4 h
Concentrations:
Aerosol concentration was 5.7 mg/l
No. of animals per sex per dose:
10 per sex
Control animals:
yes
Details on study design:
10 male and 10 female animals per group were exposed to zinc oxide aerosol (head and nose only) for 4 h. Aerosol concentration was 5.7 mg/l and the particle size distribution had a mass median aerodynamic diameter of 4 m ± 2.9 (GSD). Only one concentration and a control group were tested. All animals survived up to day 14 post exposure.
Statistics:
no information

Results and discussion

Preliminary study:
no information
Effect levels
Sex:
not specified
Dose descriptor:
LC50
Effect level:
> 5 700 mg/m³ air
Mortality:
no mortality
Clinical signs:
only a dusty fur on the head, no adverse effects noted
Body weight:
no change in body weights observed
Gross pathology:
no adverse effects observed.
Other findings:
none observed

Any other information on results incl. tables

no information

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LC50 4 hours >5.7 mg ZnO/l
Executive summary:

In an acute inhalation toxicity study, 10 male and 10 female animals per group were exposed to zinc oxide aerosol (head and nose only) for 4 h. Aerosol concentration was 5.7 mg/l and the particle size distribution had a mass median aerodynamic diameter of 4mm ± 2.9 (GSD). Only one concentration and a control group were tested. All animals survived up to day 14 post exposure. Apart from a dusty fur on the head the day after the exposure, no effects were seen. Body weights developed normally. At pathological examination all organs were normal. The LC50was >5.7 mg/l.