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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

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
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Zinc oxide
EC Number:
215-222-5
EC Name:
Zinc oxide
Cas Number:
1314-13-2
IUPAC Name:
oxozinc
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 or test system 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:
other: 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.