Registration Dossier
Registration Dossier
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EC number: 206-076-3 | CAS number: 299-29-6
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- No guideline available
- GLP compliance:
- not specified
- Remarks:
- GLP compliance of the report used to produce results not given in the publication
- Test type:
- other: no guideline available
- Limit test:
- no
Test material
- Reference substance name:
- Iron digluconate
- EC Number:
- 206-076-3
- EC Name:
- Iron digluconate
- Cas Number:
- 299-29-6
- Molecular formula:
- C12H22FeO14
- IUPAC Name:
- λ²-iron(2+) bis((2R,3S,4R,5R)-2,3,4,5,6-pentahydroxyhexanoate)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Blue Spruce Farms
- Weight at study initiation: 200-250 g
- Fasting period before study: 12 hours
- Water (e.g. ad libitum): Yes
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Tris buffer
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 1-3 ml - Control animals:
- not specified
- Details on study design:
- There are no details on the study design
- Statistics:
- Weil method
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 2 237 mg/kg bw
- Based on:
- not specified
- Mortality:
- No data
- Clinical signs:
- other: Diarrhea seen at sub-lethal and lethal doses.
- Gross pathology:
- At doses higher or equal to the LD50 - stomach and small intestine were dilated and filled with dark fluid and occasionally blood. Stomach and small intestine mucosa were covered with grey-green granular material. Ceacum and large intestine containied black liquid faeces.
At sub-lethal doses - occasional dilation of upper gastrointestinal tract with fluid. Small hamorrhages were seen in stomach or small intestine. Black liquid faeces was reported.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- LD50 (rat) is 2237 mg/kg
Iron Gluconate is not classified as hazardous - Executive summary:
Iron Gluconate is not classified as hazardous
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