Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Currently viewing:

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/EC, B.7. OECD TG 407
GLP compliance:
yes
Limit test:
no

Test animals

Species:
other: Rat, F344 Fischer.

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: 0.1 % Na-carboxmethyl cellulose plus 0.01 % Tween 80.
Details on oral exposure:
Method of administration:
Stomach intubation, 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 100 mg/kg bw/day
Male: 5 animals at 316 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 100 mg/kg bw/day
Female: 5 animals at 316 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: no mortalities occured.

Body weight: lower body weight of high dosed females at the
end of the dosing period.

Feed consumption: no test substance related effects.

Clinical and functional observations: no test substance
related effects.

Laboratory findings:
Haematology: no test substance related effects at the end of
the dosing period. Higher mean corpuscular haemoglobin
(males), platelet count (males and females) and monocytes
(males) at the end of the recovery period.

Blood chemistry: no test substance related effects at the
end of the dosing period. Higher creatinine (males) and
glucose (males and females) at the end of the recovery
period. Higher alanin aminotransferase (females) observed
only in the low dosed group.

Effects in organs:
Necropsy: no relevant findings.

Organ weights: no test substance related effects at the end
of the dosing period. Higher mass of adrenals (males) and
epididymides; lower mass of kidneys (females) at the end of
the recovery period. Higher testicular weights in the mid
dosed group at the end of the dosing period are not given
toxicological relevance due to the lack of a dose
relationship.

Histopathology: no relevant findings. One
"tissue mass" in the duodenum was not regarded as
toxicologically relevant due to single occurence.

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:
316 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