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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
repeated dose toxicity: oral
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: 96/54/EG, B.7; OECD 406 (siehe Bemerkung)
GLP compliance:
yes
Limit test:
no

Test animals

Species:
other: rat, Sprague-Dawley

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: Entgastes und gereinigtes Wasser wurde durch Umkehrosmose mit einer Milli-Ro 8 erhalten. "ENGLISH" Degased and purified water was obtained by reverse osmosis with a milli-ro 8.
Details on oral exposure:
Method of administration:
Magensonde
Duration of treatment / exposure:
Test duration: 28 days
Frequency of treatment:
Dosing regime: 7 days/week
No. of animals per sex per dose:
Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 5 mg/kg bw/day
Male: 5 animals at 15 mg/kg bw/day
Male: 5 animals at 50 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 5 mg/kg bw/day
Female: 5 animals at 15 mg/kg bw/day
Female: 5 animals at 50 mg/kg bw/day

Results and discussion

Results of examinations

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

At 50 mg/kg bw/d round back, piloerection and emaciated
appearance were observed in 2/5 males on day 28. Pallor of
the eyes and chromodacryorrhea were each observed in 1/5
females.

Decrease in food consumption in males and females at 50
mg/kg bw/d corresponded to lower body weight gain in animals
treated at these dose levels when compared to controls.

No disturbance of autonomic or physiological functions were
observed in any groups. There were no treatment-related
changes in the neurotoxicological parameters.

Laboratory findings:
At 50 mg/kg bw/d hematology revealed decrease in red blood
cell count (statistically significant for males), when
compared to control values. This was associated with a
slight decrease in hemoglobin concentration (statistically
significant for males) and slight increase in MCV and MCHC.

Effects in organs:
At 50 mg/kg bw/d male and female rats showed a statistically
significant increase in both absolute and relative spleen
weight when compared with controls.

Microscopic examination of the spleen revealed slight to
severe hemosiderosis in males and females at 50 mg/kg bw/d.
In addition, marginally higher severity of extramedullary
hematopoiesis (erythroid) in male rats was noted at 50 mg/kg
bw/d. In the female rats incidence and severity of
extramedullary hematopoiesis were comparatively similar in
both control and treated female rats.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
15 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD unit is mg/kg/day.
Dose descriptor:
NOEL
Effect level:
15 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD unit is mg/kg/day.

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Classified as: Not classified