Registration Dossier
Registration Dossier
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EC number: 451-540-2 | CAS number: -
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:
- 2003
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- Version / remarks:
- OECD 424
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Age/Weight at start: 6-week old; 202-233g (males) and 159-189g (females)
- Temp.: 22+/-2°C; RH: 30-70%; light/dark cycle: 12h/12h; ventilation: 12 cycles/h
- Housing: 1/cage ; food and water ad libitum except when fasting required
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% MC (methylcellulose) in water
- Details on oral exposure:
- - gavage using plastic syringe fitted with a metal probe
- dose-volume = 5ml/kg, adjusted to the most recent body weight - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- - Homogeneity and stability: checked at 2 and 200 mg/mL, before the study start
- Control of preparations: all concentrations including controls in weeks 1 and 4
0 (Vehicle control). - Duration of treatment / exposure:
- 29 days
- Frequency of treatment:
- once a day
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0 (vehicle controls) – 150 – 450 - 1000 mg/kg
Basis:
other: 0 (vehicle controls) – 150 – 450 - 1000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Positive control:
- None.
Examinations
- Observations and examinations performed and frequency:
- - Mortality/morbidity, Clinical signs : daily; Detailed clinical observation : weekly
- Functional Observation Battery (FOB): Once (end of dosing period)
- Body weight/Feed Intake: weekly
- Haematology (incl. coagulation) and blood biochemistry: Once (end of dosing period) - Sacrifice and pathology:
- - Organ weights and macroscopic examination: all animals
- Microscopic examination: all tssues for control and high dose rats and any gross lesion - Statistics:
- Yes (decision tree, according to distribution of data) for: Body weight , food intake, haematology, blood biochemistry and organ weights
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Sex:
- male/female
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Observations
Clinical signs and mortality
No deaths and no clinical signs at any dose. |
Body weight and weight gain
no effects |
Food consumption and compound intake (if feeding study)
No effects at any dose |
Food efficiency
not applicable |
Water consumption and compound intake (if drinking water study)
not applicable |
Ophthalmoscopic examination
Not performed |
Haematology
No relevant effects at any dose |
Clinical chemistry
No relevant effects at any dose |
Urinalysis
Not performed |
Neurobehaviour
No CNS effects according to FOB resultsat any dose |
Organ weights
No relevant effects at any dose |
Gross pathology
No major macroscopic observationsat any dose |
Histopathology: non-neoplastic
No toxicologically relevant observations |
Histopathology: neoplastic
Not applicable |
Applicant's summary and conclusion
- Conclusions:
- No overt toxicity after 4 week of oral dosing at 1000 mg/kg/day.
NOAEL = 1000 mg/kg/day po
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