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Diss Factsheets

Administrative data

Endpoint:
sub-chronic toxicity: inhalation
Adequacy of study:
other information

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 87/302/EWG, B.29; OECD 413 (1981)
GLP compliance:
yes
Limit test:
no

Test material

Details on test material:
Batch no : A4305 05008

Test animals

Species:
other: rat, Wistar Crl:(WI)WU BR
Sex:
male/female

Administration / exposure

Route of administration:
inhalation
Vehicle:
other: None.
Details on inhalation exposure:
Method of exposure:
nose-only
Duration of treatment / exposure:
Test duration: 90 days
Frequency of treatment:
Duration of exposure per day: 6 hours
Dosing regime: 5 days/week
No. of animals per sex per dose:
Male: 10 animals at 0 mg/l
Male: 10 animals at 8.9 mg/l
Male: 10 animals at 26.9 mg/l
Male: 10 animals at 80.7 mg/l
Female: 10 animals at 0 mg/l
Female: 10 animals at 8.9 mg/l
Female: 10 animals at 26.9 mg/l
Female: 10 animals at 80.7 mg/l
Control animals:
yes

Results and discussion

Results of examinations

Details on results:
Clinical observations:
There were no test substance related deaths.

No changes in breathing pattern or behaviour were observed.
No abnormalities were noted after exposure. Individual daily
observations prior to exposure revealed sparsely haired skin
in females exposed to 26.9 or 80.7 ppm. A significant
decrease in body weight gain was observed in males and
females exposed to 26.9 or 80.7 ppm. A significant decrease
in food intake was seen in males and females exposed to

80.7 ppm. Food conversion efficiency was also decreased in
males of this test group.

Laboratory findings:
Haematology revealed statistically significantly prolonged
prothrombin time in males exposed at 80.7 ppm.

Clinical biochemistry revealed statistically significantly
increases in alanine aminotransferase activity (males and
females), triglyceride concentration (females), and
albumin/globulin ratio (males) at 80.7 ppm when compared to
controls. The chloride concentration was decreased in a
concentration-related way and reached significance in males
exposed to 26.9 or 80.7 ppm and in females exposed to

80.7 ppm.

A statistically significantly increase in urinary volume and
a tendency towards decreased urinary density were found in
females exposed to 80.7 ppm.

Effects in organs:
After four weeks of exposure to 80.7 ppm statistically
significantly increased relative and absolute liver weights
were observed in females. Later after 13 weeks of exposure
relative weight of the liver was significantly increased in
both males and females. Absolute liver weight was also
significantly higher in females of this test group when
compared to controls. Relative weight of the kidneys was
statistically significantly increased in females exposed to
80.7 ppm.

No test substance-related macroscopic or microscopic
findings were recorded.

Effect levels

open allclose all
Dose descriptor:
NOAEC
Effect level:
< 8.9 ppm
Basis for effect level:
body weight and weight gain
organ weights and organ / body weight ratios
urinalysis
Dose descriptor:
NOAEC
Effect level:
0.04 mg/L air
Based on:
not specified
Basis for effect level:
body weight and weight gain
organ weights and organ / body weight ratios
urinalysis

Applicant's summary and conclusion

Conclusions:
Not classified