Registration Dossier
Registration Dossier
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EC number: 236-751-8 | CAS number: 13473-90-0
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:
- other: Published study; detailed findings not reported but data considered adequate for LD50 determination and hazard classification purposes.
Data source
Reference
- Reference Type:
- publication
- Title:
- Acute Toxicity studies of aluminium compounds: Antidotal efficacy of several chelating agents
- Author:
- Llobet JM, Domingo JL, Gomez M, Tomas JM, Corbella J
- Year:
- 1 987
- Bibliographic source:
- Pharmacology & Toxicology 60: 280-283
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- : detailed findings not reported
- Principles of method if other than guideline:
- Guideline-comparable assessment of the oral LD50 in the rat. LD50 results are reported as part of a preliminary investigation into the assesment of efficacy of chelating agents
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Aluminium nitrate
- EC Number:
- 236-751-8
- EC Name:
- Aluminium nitrate
- Cas Number:
- 13473-90-0
- Molecular formula:
- Al.3HNO3
- IUPAC Name:
- aluminum trinitrate
- Test material form:
- not specified
- Details on test material:
- Al(NO3)3*9 H2O (source: Merck)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Interfauna Iberica (Barcelona, Spain)
- Weight at study initiation: 230-280 g
- Diet: ad libitum, Standard pellet diet (Source: Panlab, Barcelona, Spain)
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- physiological saline
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED:
The concentrations were adjusted so that a 250 g rat received 1 ml. - Doses:
- No data
- No. of animals per sex per dose:
- 3 males and 3 females
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: not specified
- Necropsy of survivors performed: not specified
- Other examinations performed: not specified - Statistics:
- The LD50 value was calculated according to the method of Litchfield & Wilcoxon (1949).
Results and discussion
- Preliminary study:
- LD50 values were established as part of a preliminary investigation into the assesment of efficacy of chelating agents.
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 060
- Based on:
- other: anhydrous salt equivalent
- 95% CL:
- >= 1 760 - <= 2 407
- Remarks on result:
- other: Calculated based on Al3+ content in anhydrous aluminium nitrate
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 3 263 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 3 103 - <= 4 248
- Remarks on result:
- other: Reported value for the test material: aluminium nitrate nonahydrate
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 261 mg/kg bw
- Based on:
- element
- Remarks:
- : Al
- 95% CL:
- >= 223 - <= 305
- Remarks on result:
- other: Reported value for Al3+ equivalents
- Mortality:
- no data presented
- Clinical signs:
- other: no data presented
- Gross pathology:
- no data presented
- Other findings:
- no data
Any other information on results incl. tables
The acute oral LD50 of aluminium nitrate nonahydrate in the rat was reported to be 3622 mg/kg bw; equivalent to 261 mg/kg bw Al; equivalent to 2060 mg/kg bw anhydrous aluminium nitrate
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral LD50 of anhydrous aluminium nitrate in the rat was calculated to be 2060 mg/kg bw.
- Executive summary:
LD50 values for aluminium nitrate were established as part of a preliminary investigation into the assesment of efficacy of chelating agents. The acute oral LD50 of aluminium nitrate nonahydrate in the rat was reported to be 3622 mg/kg bw; equivalent to 261 mg/kg bw Al; equivalent to 2060 mg/kg bw anhydrous aluminium nitrate
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