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Toxicological information

Repeated dose toxicity: inhalation

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Administrative data

Endpoint:
sub-chronic toxicity: inhalation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Non GLP study, non guideline study. Very limited information reported on study design.

Data source

Reference
Reference Type:
publication
Title:
A Study of the Effects on the Lung of Industrial Exposure to Zirconium Dusts
Author:
Reed CE
Year:
1956
Bibliographic source:
Archives of industrial Dealth See AMA Arch. Ind. Health; Journal Volume: Vol: 13, pages 578-580; Other information: Orig. Receipt Date: 31-Dec-1957

Materials and methods

Principles of method if other than guideline:
No guideline followed.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Automatically generated during migration to IUCLID 6, no data available
IUPAC Name:
Automatically generated during migration to IUCLID 6, no data available
Details on test material:
- Name of test material (as cited in study report): zirconium dust

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: 2 years old
- Weight at study initiation: no data
- Fasting period before study: no data
- Housing: placed in cages in the plant
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
not specified
Vehicle:
not specified
Details on inhalation exposure:
Guinea pigs were placed in cages in the plant as near as possible to heaviest concentration of dusts at different steps of the zirconium production process.
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
The plant was in continuous 24-hour operation, and the guinea pigs were kept in this environment constantly for 2 to 6 months.
Frequency of treatment:
Continuously
No. of animals per sex per dose:
No data
Details on study design:
No further details available
Positive control:
No data

Examinations

Observations and examinations performed and frequency:
No data
Sacrifice and pathology:
All animals were killed and autopsied, and the lungs examined histologically.
Other examinations:
No data

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Mortality:
mortality observed, treatment-related
Body weight and weight changes:
not specified
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
effects observed, treatment-related
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Histopathological findings: neoplastic:
not specified
Details on results:
Several of the guinea pigs died during the exposure, and the remainder were killed after six months. All animals were autopsied, and the lungs examined histologically. There was no evidence of inflammatory reaction, granuloma formation, or fibrosis in the lungs of any of the animals.

Effect levels

Dose descriptor:
NOAEC
Remarks on result:
not determinable
Remarks:
no NOAEC identified

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The possibility that dusts encountered in the production of zirconium metal might produce pulmonary granulomas was investigated by animal exposure. No abnormalities attributable to zirconium were found.

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