[No public or meaningful name is available]

Toxicity to reproduction

Administrative data

Endpoint:

one-generation reproductive toxicity

Remarks:

based on test type (migrated information)

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: OECD 415 (2001)

GLP compliance:

yes

Limit test:

no

Test animals

Species:

other: rat, Wistar Crl:WI WU BR

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

other: diet

Details on exposure:

Method of administration or exposure: oral

Frequency of treatment:

Dosing regime (males): 7 days/week
Dosing regime (females): 7 days/week

Details on study schedule:

Number of litters per dose/conc.: 1 at mg/kg or mg/l

No. of animals per sex per dose:

Male: 25 animals at 0 mg/kg or mg/l
Male: 25 animals at 43.5 mg/kg or mg/l
Male: 25 animals at 168.4 mg/kg or mg/l
Male: 25 animals at 844.4 mg/kg or mg/l
Female: 25 animals at 0 mg/kg or mg/l
Female: 25 animals at 55.3 mg/kg or mg/l
Female: 25 animals at 212.3 mg/kg or mg/l
Female: 25 animals at 1031 mg/kg or mg/l

Results and discussion

Results: P0 (first parental generation)

Details on results (P0)

There were no increase in mortality, no clinical symptoms
due to the test substance as well as no adverse effects on
body weights and food intake up to 10000 ppm in FO rats.


No macroscopical findings due to the treatment were observed
up to 10000 ppm.


In 2000 and 10000 ppm rats clearly increased incidences

of eosinophilic or condensed cytoplasma of periportal
hepatocytes were noted. As in two 500 ppm females such
finding was present with a relative high grading the 500 ppm
concentration is considered as a borderline dose for this
finding in females.

At 2000 and 10000 ppm in males and/or females also
hepatocytes with a cobblestone pattern or showing cell
hypertrophy occurred more frequently. At 10000 ppm this
finding correlated with increased liver weights of females.
In the spleen of 10000 ppm rats congestion and/or increased
extramedullary hemopoiesis occurred more frequently than in
the other groups. At 10000 ppm this finding correlated with
increased spleen weights of males and females.


Examinations on sperms and estrus cycling as well as
histopathological evaluations of reproductive organs
revealed no substance-related effects up to 10000 ppm.


The parameters of the reproductive performance such as
insemination, fertility, gestation and rearing indices as
well as gestation length were not influenced up to

10000 ppm.

Results: F1 generation

Details on results (F1)

Effects on F1 generation:
The litter data such as mean number of implantations and
prenatal loss, live birth, viability and lactation indices,
sex distribution, number of pups born and litter sizes were
not affected by the test substance at levels of up to

10000 ppm.


Concerning clinical findings of pups there were no changes
up to 10000 ppm in Fl pups.


The pup weights were not toxicologically relevantly changed
up to 2000 ppm. There was a slight body weight retardation
in male and female weanlings on day 28 (p > 0.05), which is
interpreted as a systemic effect due to own intake of the
test substance via diet rather than an effect on
reproduction.


At pup or weanling necropsies including organ weight
measurements no remarkable findings were noted up to

10000 ppm.

Overall reproductive toxicity

Reproductive effects observed:

not specified