Registration Dossier
Registration Dossier
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EC number: 431-850-4 | CAS number: 7456-68-0
Repeated dose toxicity: oral
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: 92/69/EWG, B,7; OECD 407 (1995)
- GLP compliance:
- yes
- Limit test:
- no
Test animals
- Species:
- other: rat, Fischer 344
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: Diät (Futter) "ENGLISH" diet (food)
- Details on oral exposure:
- Method of administration:
Futter (food) - 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 4 mg/kg bw/day
Male: 5 animals at 20 mg/kg bw/day
Male: 5 animals at 100 mg/kg bw/day
Male: 5 animals at 500 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 4 mg/kg bw/day
Female: 5 animals at 20 mg/kg bw/day
Female: 5 animals at 100 mg/kg bw/day
Female: 5 animals at 500 mg/kg bw/day
Results and discussion
Results of examinations
- Details on results:
- Clinical observations:
Es traten keine behandlungsbedingten Todesfälle auf.
Dosisabhängig wurde bei den männlichen und den weiblichen
Tieren der 500 mg-Dosierung und bei den Männchen in der
100 mg-Dosierung eine Reduktion der Körpergewichtszunahme
und -entwicklung sowie der Futteraufnahme festgestellt.
"ENGLISH"
No deaths.
Doses related in males and females of the 500 mg group and
in the males of the 100 mg group a reduction of the
bodyweight development and weight increase and in the food
consumption were found.
Laboratory findings:
Bei beiden Geschlechtern der 500 mg-Dosierung war der Gehalt
von Hämoglobin erniedrigt sowie der von Cholesterol und
Kalium erhöht. Bei beiden Geschlechtern in der 500 mg- und
100 mg-Dosierung war der pH-Wert des Harns erhöht. Ein
erniedrigtes spezifisches Harngewicht wurde bei beiden
Geschlechtern in der 500 mg-Dosierung und bei den Männchen
in der 100 mg-Dosierung beobachtet.
"ENGLISH"
In both sexes of the 500 mg group the concentration of
hemoglobine was reduced and the of cholesterol and pottasium
was increased. In both sexes in the 500 mg and 100 mg group
the pH-value of the urine was increased. A reduced specific
urine weight was found in both sexes of the 500 mg group and
in the males of the 100 mg group.
Effects in organs:
Substanzinduzierte histomorphologische Effekte wurden in den
Lungen bei allen Männchen und Weibchen in der 500
mg-Dosierung sowie in den Nieren und in der Harnblase bei
fast allen Tieren in der 500 mg- und 100 mg-Dosierung
beobachtet. In den Lungen fanden sich eine mittelgradige,
diffuse chronische Alveolitis, Mineralisation der
Alveolarsepten und eine geringgradige multifokale
Alveolarhämorrhagie. In den Nieren waren am
Sammelröhrenepithel der Nierenpapille eine leichte
Hypertrophie, kombiniert von granulärer roter Pigmentation,
vereinzelt Nekrosen und umschriebene akute Entzündungen und
am Nierenbeckenepithel Hyperplasie und/oder Mineralisation
zu beobachten. Hyperplasie und vereinzelt Nekrosen wurden am
Übergangsepithel der Harnblase gesehen.
"ENGLISH"
Substance induced histomorphological effects were found in
lungs of all males and females of the 500 mg group and in
the kidneys and in the bladder of nearly all animals of the
500 mg and 100 mg groups. In the lungs middle grade, diffus
chronical alveolitis, mineralisation of the alveolarsepti
and low grade multifocal alveolar hemorrhagia were found. In
the kidneys at the collecting tubulli of the kidney papilla
a slight hypertrophy combined of granuler red pigmentation,
single necrosis and defined acute irritations and at the
renal pelvis epithel hyperplasia and/or mineralisaions were
observed. Hyperplasia and single necrosis were seen at the
transitional epithelium of the bladder.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 20 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
- Dose descriptor:
- NOEL
- Effect level:
- 20 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
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