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EC number: 410-940-7 | CAS number: 60166-91-8 LACTOFTALURO
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: EEC B7 Repeated dose (4 weeks) toxicity study in rats by oral route followed by a 4 week recovery period.
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- (S)-5-[2-(acetyloxy)propanamido]-2,4,6-triiodo-1,3-di(chloroformyl)benzene
- EC Number:
- 410-940-7
- EC Name:
- (S)-5-[2-(acetyloxy)propanamido]-2,4,6-triiodo-1,3-di(chloroformyl)benzene
- Cas Number:
- 60166-91-8
- Molecular formula:
- C13H8Cl2I3NO5
- IUPAC Name:
- 1-{[3,5-bis(carbonochloridoyl)-2,4,6-triiodophenyl]carbamoyl}ethyl acetate
- Test material form:
- solid: particulate/powder
1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: 0.5% Methylcellulose (400 cps) in water.
- 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 50 mg/kg bw/day
Male: 5 animals at 250 mg/kg bw/day
Male: 10 animals at 1000 mg/kg bw/day
Female: 5 animals at 50 mg/kg bw/day
Female: 5 animals at 250 mg/kg bw/day
Female: 10 animals at 1000 mg/kg bw/day
Results and discussion
Results of examinations
- Details on results:
- Clinical observations:
Lactoftaluro did not induce the appearance either of
clinical signs or body weight modifications.
Food intake was similar in control and treated groups during
both experimental and recovery phases.
Ophtalmoscopic examinations did not show test substance
related modifications.
Laboratory findings:
Hematology, blood chemistry and urinalysis at the end of
both experimental (all groups) and recovery periods (control
group and 3 only) did not show test substance-related
modifications.
Effects in organs:
a) Organ weights at the end of experimental and recovery
periods were similar in control and treated animals.
b) No gross modifications were observed at the autoptic
examinations.
c) No microscopic modifications were observed at the
histological examinations.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
- Dose descriptor:
- NOEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- 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
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