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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
other: body responsible for the test
Title:
Unnamed
Year:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Annex Ⅴ
GLP compliance:
yes
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: RAT(sprague-dawley)

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: 0.5% aqueous carboxymethylcellulose
Details on oral exposure:
Method of administration: Oral gavage
Duration of treatment / exposure:
test duration:28 days
Frequency of treatment:
DOSING REGIME : 7DAYS/WEEK
No. of animals per sex per dose:
Male: 10 animals at mg/kg bw/day
Male: 10 animals at 10 mg/kg bw/day
Male: 10 animals at 50 mg/kg bw/day
Male: 10 animals at 500 mgfkg bw/day
Female: 10 animals at mg/kg bw/day
Female: 10 animals at 10 mg/kg bw/day
Female: 10 animals at 50 mg/kg bwJday
Female: 10 animals at 500 mg/kg bw/day

Results and discussion

Results of examinations

Details on results:
Clinical observations:
No death and no effects in bodyweight gain or food
consumption in females (500 mg/kg/day) from the end of the
the second week which persisted through the recovery period.

There was no statistically significant changes in haemalological parameters. A slight,reversinle anaemia was
observed in top dose animals (dedcreases potassium,femails;

Increassed total protelns,colesterol ,gammaglutamyl transferase in females; Increase albumln and creatlnlne in males) and a moderate Increase in triglycerldes in toip dose females were considered treatment related. AII observed changes were reversible after the treatment-free period.

Urinanysls showed slightly increased incidence and severity of epithellal cells in males (500 mg/kg/day) and incidence
in top dose females ,reducing substances were slightly
increased in top dose animals,more marked in males than
females. These effects were reverslble.

Effect levels

Dose descriptor:
NOAEL
Effect level:
ca. 50 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD units is mg/kg/day

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
not classified