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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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 guideline and non GLP study. Only one single intratracheal application of the test substance and observation of the test animals over 8 months.

Data source

Reference
Reference Type:
publication
Title:
Effect on the organism of rare, dispersed, and other metals, and their compounds used in industry: zirconium
Author:
Mogilevskaya, O. Ya
Year:
1968
Bibliographic source:
National Science Foundation: Toxicology of rare metals, Washington D.C., 1967, pg 44

Materials and methods

Test guideline
Qualifier:
no guideline followed
GLP compliance:
no
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Zirconium
EC Number:
231-176-9
EC Name:
Zirconium
Cas Number:
7440-67-7
IUPAC Name:
zirconium(2+)

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
other: intratracheal
Vehicle:
other: physiological saline
Remarks on MMAD:
MMAD / GSD: 90 % of particles are smaller than 2 µm.
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
8 months
Frequency of treatment:
once at the beginning of the study.
Doses / concentrations
Remarks:
Doses / Concentrations:
50 mg suspended in physiological saline
Basis:
nominal conc.
No. of animals per sex per dose:
26 animals
Control animals:
yes, concurrent no treatment
Positive control:
Not examined.

Examinations

Observations and examinations performed and frequency:
No data.
Sacrifice and pathology:
GROSS PATHOLOGY: Yes. Animals were killed after 4 and 8 months.
HISTOPATHOLOGY: Yes

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
not examined
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
not examined
Ophthalmological findings:
not examined
Haematological findings:
not examined
Clinical biochemistry findings:
not examined
Urinalysis findings:
not examined
Behaviour (functional findings):
not examined
Organ weight findings including organ / body weight ratios:
not examined
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Description (incidence and severity):
in the lungs
Histopathological findings: neoplastic:
not examined
Details on results:
CLINICAL SIGNS AND MORTALITY
No mortality was observed during the eight months observation period. All animals remained healthy.

BODY WEIGHT AND WEIGHT GAIN
The body weight differed only little from that of the control animals.

GROSS PATHOLOGY
No treatment related gross changes were observed in the organs of all animals.

HISTOPATHOLOGY: NON-NEOPLASTIC
The lungs of each animal (Pathology after 4 months) were examined microscopically and cellular accumulations around the dust particles were observed. Furthermore the thickening of the interalveolar septa was seen due to the proliferation of histiocytes and fibroblasts. Throughout the entire lung large amounts of dust were observed.
After eight months the process of cellular accumulation had progressed slowly with increasing number of connecting tissue fibers in the foci and in the thickening of the interalveolar septa. Proliferation of connective tissue cells and fibrosis around vessels and bronchi of all kinds was also observed. Furthermore areas of emphysema, and thickening and swelling of the blood vessels was seen. In the bronchial glands large amounts of dust were found.

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