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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 407 (1995)
GLP compliance:
yes
Limit test:
no

Test animals

Species:
other: rat, Wistar Rj:WI (IOPS Han.)

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: aqueous 0.5 % methylcellulose 400
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 0 mg/kg bw/day
Male: 5 animals at 5 mg/kg bw/day
Male: 5 animals at 40 mg/kg bw/day
Male: 5 animals at 160 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 40 mg/kg bw/day
Female: 5 animals at 160 mg/kg bw/day

Results and discussion

Results of examinations

Details on results:
Clinical observations:
One female rat treated with 160 mg/kg bw/d was killed for
humane reasons on study day 17. Before sacrifice this animal
showed increased post-dose salivation, reduced motor
activity, labored respiration and cold to touch. Necropsy
and microscopy did not neither reveal an indication

of the cause of death, nor a relation of these deaths to
administration of the test substance. In particular, there
was no evidence of administration failure.

There were no clinical signs apart from post-dose salivation
in animals receiving 160 mg/kg bw/d. No test substance-
related effects in body weight and food consumption were
seen in male and female rats treated with doses up to

160 mg/kg bw/d.

Neurotoxicological measurements including locomotor
activity, "open field" observations, assessment of sensory
function, and forelimb and hind-limp grip strength were not
influenced by the administration of the test substance.

Laboratory findings:
No test substance-related differences in hematology
parameters were noted when compared with the control values.
Clinical biochemistry revealed statistically significant
lower mean total protein concentrations for the 160 and

40 mg/kg bw/d females (-8 % and -5 %, respectively).

No treatment-related changes were found in urinalysis of
either sex.

Effects in organs:
At 160 mg/kg bw/d male rats showed a statistically
significantly decrease in both absolute and relative spleen
weights when compared with controls.

No test substance-related macroscopic or microscopic
findings were recorded.

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