Registration Dossier
Registration Dossier
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EC number: 454-140-6 | CAS number: 376608-71-8
Repeated dose toxicity: other routes
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:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V Method B7
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 407
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 454-140-6
- EC Name:
- -
- Cas Number:
- 376608-71-8
- Molecular formula:
- C9H9F2N*C8H8O3
- IUPAC Name:
- (1R)-2-(3,4-difluorophenyl)cyclopropan-1-aminium (2R)-2-hydroxy-2-phenylacetate
- Details on test material:
- test substance ref. no: Y12731/001
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system 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
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