Registration Dossier
Registration Dossier
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EC number: 943-434-4 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Study was not performed according to a specific guideline or according GLP principles and was performed with a limited number parameters examined.
Data source
Reference
- Reference Type:
- other: Part of application for product licence
- Title:
- Unnamed
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Mortality examination of mice after 5 different dose levels of Hydrotalcite.
- GLP compliance:
- no
- Test type:
- other: see below
- Limit test:
- no
Test material
- Reference substance name:
- [carbonato(2-)]hexadecahydroxybis(aluminium)hexamagnesium
- EC Number:
- 234-319-3
- EC Name:
- [carbonato(2-)]hexadecahydroxybis(aluminium)hexamagnesium
- Cas Number:
- 11097-59-9
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: DD strain
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Male mice were used throughout, having a body weight of approximately 20 g.
Administration / exposure
- Route of administration:
- other: oral, intraperitoneal and subcutaneous
- Vehicle:
- not specified
- Details on oral exposure:
- Hydrotalcite was administered in tragacanth suspensions.
- Doses:
- 2000, 4000, 6000, 8000 and 10000 mg/kg.
- No. of animals per sex per dose:
- Groups of 10 mice were used at each dose level.
- Control animals:
- no
- Details on study design:
- Observations were made for a period of 1 week.
- Statistics:
- No.
Results and discussion
- Mortality:
- No mortality observed.
- Clinical signs:
- other: No data available.
- Gross pathology:
- No data available.
- Other findings:
- No other data available.
Applicant's summary and conclusion
- Conclusions:
- Hydrotalcyte caused no mortality when administered by any route at dosages up to 10 gram/kg.
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