Registration Dossier
Registration Dossier
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EC number: 219-323-5 | CAS number: 2414-98-4
Repeated dose toxicity: other routes
Administrative data
- Endpoint:
- repeated dose toxicity: other route
- Type of information:
- not specified
- Adequacy of study:
- weight of evidence
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: This study is not comparable to any guidelines
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 973
Materials and methods
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Magnesium hydroxide
- EC Number:
- 215-170-3
- EC Name:
- Magnesium hydroxide
- Cas Number:
- 1309-42-8
- Molecular formula:
- H2MgO2
- IUPAC Name:
- magnesium dihydroxide
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Albino
- Sex:
- male/female
Administration / exposure
- Route of administration:
- other: implantation
- Vehicle:
- water
- Duration of treatment / exposure:
- 2, 4, 8, 16, 32 and 64 days
- Frequency of treatment:
- Continuous
Doses / concentrations
- Remarks:
- Doses / Concentrations:
3 mm spherical pellets. Each rat had four implants: calcium hydroxide, magnesium hydroxide, plaster of Paris, sponge (control)
- No. of animals per sex per dose:
- Thirty six rats in total. Six were killed at each timepoint.
- Control animals:
- other: Each rat was implanted with the test material and the control (sponge)
Results and discussion
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Two magnesium hydroxide implants extruded through ulcerations. Some of the implants retained showed the production of mineralized material in the surrounding connective tissue capsule. However, magnesium hydroxide caused only a mild tissue reaction.
Applicant's summary and conclusion
- Conclusions:
- Magnesium hydroxide did not react with skin tissue in the rats during this study.
- Executive summary:
Magnesium hydroxide pellets (3 mm diameter) implanted under the skin of albino rats for 64 days induced only mild tissue inflammation.
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