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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: OECD 407
GLP compliance:
yes
Limit test:
no

Test animals

Species:
other: rat / Wistar Hoe: WISKF (SPF 71)

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: sesame oil
Details on oral exposure:
Method of administration:
Suspension
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 40 mg/kg bw/day
Male: 5 animals at 200 mg/kg bw/day
Male: 5 animals at 1000 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 40 mg/kg bw/day
Female: 5 animals at 200 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/day

Results and discussion

Results of examinations

Details on results:
Clinical observations:
No lethality.

Increased salivation, irregular respiration and crunched
posture as well as swelled up abdomen in females in the high
dose group occurred. In some animals of the intermediate
group also an increased salivation was observed.

In some males of the high dose group a slight decrease of
the body weight was detected. In the females the food
consumption was slightly increased in the high dose group,
also the water consumption was increased of males and
females as well as of some males in the intermediate group.

Laboratory findings:
The haematologic examinations did not show any changes.
Clinical-chemical a slight increase of the GGT-activity in
the females and in one male of the high dose animals was
observed.

In the urine an increased number of precipitations was seen
in animals of the high and intermediate dose group. In the
females of the high dose group additionally an increase of
the volume and in all animals a turbidity was observed.

Effects in organs:
The organ weights of liver, kidneys and adrenals were
increased in the animals of the high dose group. In the
males of the intermediate dose group a slight increase of
the relative kidney weights and in females a slight increase
of the relative liver weights was detected.

Histopathologic liver necrosis was detected in three females
of the high dose group.

In two animals of the intermediate dose and in four animals
of the high dose group changes induced by foreign bodies
were observed in the bladder.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
40 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD unit is mg/kg/day.
Dose descriptor:
NOEL
Effect level:
40 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