Registration Dossier
Registration Dossier
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EC number: 417-220-1 | CAS number: 37441-29-5 ATIPACL
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
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:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 10% suspension in a 1% aqueous dispersion of CMC
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5/sex
- Control animals:
- no
- Details on study design:
- main study: test article as a 10% (w/v) suspension, pH=5.2, T=16.6°C
Examinations 15 min after intubation, then at 1, 2 and 4 h then each day for 14 days
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality observed
- Clinical signs:
- other: no clinical signs
- Gross pathology:
- no gross pathology observation on euthanisied animals
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified as harmful/toxic according to the CLP Regulation (EC) No.1272/2008
- Conclusions:
- LD50 (oral) > 2000 mg/kg bw (male/female, rat)
- Executive summary:
The test item was evaluated for acute oral toxicity in Sprague-Dawley rats according to OECD Guideline No. 401. The substance was administered to groups of 5 animals per sex by oral gavage at the dose of 2000 mg/kg.
The animals were observed for clinical signs of toxicity and mortality. No clinical signs or mortality was observed. The animal body weight had a normal evaluation. No gross pathological changes were observed on euthanisied animals.
The LD50 (oral) is > 2000 mg/kg bw (male/female, rat).
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