Registration Dossier

Administrative data

repeated dose toxicity: inhalation
Data waiving:
other justification
Justification for data waiving:

Data source

Reference Type:
other: Body responsible for the test

Materials and methods

Test guideline
according to guideline
other: Meets the then current EPA guidelines, therefore comparable to OECD 413.
GLP compliance:
Limit test:

Test animals

other: Rat, Fischer-344 albino

Administration / exposure

Route of administration:
other: Air.
Details on inhalation exposure:
Method of exposure:
Whole body inhalation
Mass median aerodynamic diameter:
The micronised test material was particle sized and found to
have an equivalent aerodynamic diameter of 4.7 microns with
a GSD of 2.24.
Duration of treatment / exposure:
Test duration: 90 days
Frequency of treatment:
Duration of exposure per day: 6 hours
Dosing regime: 7 days/week
No. of animals per sex per dose:
Male: 10 animals at 22 mg/l
Male: 10 animals at 80 mg/l
Male: 10 animals at 251 mg/l
Female: 10 animals at 22 mg/l
Female: 10 animals at 80 mg/l
Female: 10 animals at 251 mg/l

Results and discussion

Results of examinations

Details on results:
Clinical observations:
No animals died over the course of the study, and no
exposure-related pharmacotoxic signs were noted. Both males
and femals exposed to 251 mg/m3 exhibited depressed
bodyweights. At 22 mg/m3 bodyweights were similar to
controls. Food consumption was very slightly depressed but
only at the 251 mg/m3 exposure level.

Laboratory findings:
Serum vanadium levels were elevated in a dose-related
manner, but the increases were not proportional to dose. No
ophthalmological abnormalities were noted. Elevated
erythrocyte counts and depressed MVC, MCH and MCHC levels
were noted in exposed animals. Platelet counts were also
elevated in both males and females exposed to the high
level. Some serum biochemical differences were noted, i.e.,
elevated alanine aminotransferase and urea nitrogen levels,
but the significance of these observations could not be
determined from the data available.

Effects in organs:
As expected from an inhalation dust exposure, lung weights
were elevated and mediastinal lymph nodes were enlarged.
Alveolar bronchiolisation was noted at the highest exposure
level, while type II pneumocyte hyperplasia was noted at the
lowest exposure level.

Effect levels

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Dose descriptor:
Effect level:
80 mg/L air
Basis for effect level:
other: exposure duration: 6 hours/day
Dose descriptor:
Effect level:
< 22 mg/L air
Basis for effect level:
other: exposure duration: 6 hours/day

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Classified as: Not classified