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Registration Dossier
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EC number: 417-220-1 | CAS number: 37441-29-5 ATIPACL
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:
- 1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- Version / remarks:
- according to EEC directive 92/69 B7
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 5-amino-2,4,6-triiodo-1,3-benzenedicarbonyldichloride
- EC Number:
- 417-220-1
- EC Name:
- 5-amino-2,4,6-triiodo-1,3-benzenedicarbonyldichloride
- Cas Number:
- 37441-29-5
- Molecular formula:
- C8H2Cl2I3NO2
- IUPAC Name:
- 5-amino-2,4,6-triiodobenzene-1,3-dicarbonyl dichloride
- Test material form:
- solid: particulate/powder
- Remarks:
- powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Wistar strain WI
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- 7 days/week
- No. of animals per sex per dose:
- 10 males at 0 mg/kg bw/day; 5 males at 50-200-1000 mg/kg bw/day
10 females at 0 mg/kg bw/day; 5 females at 50-200-1000 mg/kg bw/day - Control animals:
- yes, concurrent vehicle
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- no clinical signs of toxicity or behavioural changes over the 28d observation period that were related to treatment
- Mortality:
- no mortality observed
- Description (incidence):
- no clinical signs of toxicity or behavioural changes over the 28d observation period that were related to treatment
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- no treatment related effects noted
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- no effect over the 28d observation period that were related to treatment
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- no effects observed
- Description (incidence and severity):
- no effect over the 28d observation period that were related to treatment
- Behaviour (functional findings):
- no effects observed
- Description (incidence and severity):
- no behavioural changes over the 28d observation period that were related to treatment
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- no treatment related effect over the 28d observation period that were related to treatment
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- Incidental findings were within the normal biological variation of result of oral administration and the taste of the test substance.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- not specified
- 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:
- not specified
- Sex:
- male/female
- Basis for effect level:
- other: original NCD unit is mg/kg/day
Target system / organ toxicity
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- NOAEL = 1000 mg/kg/day (rat, male/female)
- Executive summary:
The test substance was evaluated for toxicological effects in male and female Wistar strain WI rats according to EU Method 7 following oral dietary administration at levels of 50, 200 and 1000 mg/kg/day seven days a week for 28 days. No mortality was observed. No clinical signs of toxicity or behavioural changes over the 28d observation period that were related to treatment were observed. Incidental findings were within the normal biological variation of result of oral administration and the taste of the test substance.
The NOAEL for this study is 1000 mg/kg bw/day (nominal).
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