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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Repeated dose toxicity: oral

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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: EEC Directive 96/54 B.7 (OECD 407)
GLP compliance:
yes
Limit test:
no

Test animals

Species:
other: SPF-bred Wistar rats

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: PEG 300
Details on oral exposure:
Method of administration:
gavage
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 50 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 50 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:
Mortality/viability: All animals survived until scheduled
necropsy.

Clinical signs: No test item related clinical signs in males
or females during daily or weekly observations.


Functional observational battery

No clinical signs.

Grip strength: No changes in mean fore or hind limb grip
strength of all test item treated males and females were
observed when compared with controls.

Locomotor activity: no test item related changes were noted
over the observation period of one hour when compared with
controls.

Food consumption: the mean absolute and relative food
consumption of test item treated animals compared well with
controls.

Body weight: no test item related changes in mean body
weight and in mean body weight gain were seen when compared
with controls.

Laboratory findings:
Hematology: No test item related changes in parameters of
hematology were noted when compared with controls at the end
of the treatmente period.

Clinical Biochemistry: No test item related changes in
parameters of clinical biochemistry were noted when compared
with controls at the end of the treatment period.

Effects in organs:
No test item related differences in mean organ weights,
organ to body weight or organ to brain weight-ratios were
seen when compared with controls at the end of the treatment
period.

Macro/microscopic findings: Neither macroscopic nor
microscopic findings that could be considered related to the
treatment were observed.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD unit is mg/kg/day.
Dose descriptor:
NOEL
Effect level:
1 000 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