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Toxicological information

Repeated dose toxicity: other routes

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Administrative data

Endpoint:
short-term repeated dose toxicity: other route
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: Annex V Method B7
Qualifier:
according to
Guideline:
other: OECD 407
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
test substance ref. no: Y12731/001

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Rat - Alpk:APfSD

Administration / exposure

Route of administration:
other: gavage
Vehicle:
other: 0.5% w/v aqueous carboxymethyl cellulose
Details on exposure:
Method of administration:
gavage
Duration of treatment / exposure:
Test duration: 28 days
Frequency of treatment:
Dosing regime: 7 days/week
Doses / concentrations
Remarks:
Doses / Concentrations:
3 mg/kg bw/day
15 mg/kg bw/day
30 mg/kg bw/day

No. of animals per sex per dose:
Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 3 mg/kg bw/day
Male: 5 animals at 15 mg/kg bw/day
Male: 5 animals at 30 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 3 mg/kg bw/day
Female: 5 animals at 15 mg/kg bw/day
Female: 5 animals at 30 mg/kg bw/day

Results and discussion

Results of examinations

Details on results:
Clinical observations:
At 30 mg/kg/day: salivation and facial staining in both
sexes before dosing and during the Functional Observation
Battery (FOB) clinical assessment.


At 15 mg/kg/day: salivation or stains around the nose
during the latter part of the study were seen, but only in
one of each sex. These findings were also recorded during
the FOB.

Laboratory findings:
At 30 mg/kg/day: lower bodyweight and food consumption in
males. Landing foot splay was smaller than control for
males, however, in the absence of other changes in the FOBs,
this finding is considered not to be adverse.


At 15 mg/kg/day, landing foot splay was smaller than control
in males, however, in the absence of other changes in the
FOBs, this finding is considered not to be adverse.

Effects in organs:
None at any dose level.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
15 mg/kg bw/day
Dose descriptor:
NOEL
Effect level:
3 mg/kg bw/day
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: STOT Repeated