Registration Dossier
Registration Dossier
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EC number: 245-018-1 | CAS number: 22464-99-9
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- experimental study
- 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:
- 1 956
- 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
- 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
Constituent 1
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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