Registration Dossier
Registration Dossier
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EC number: 215-138-9 | CAS number: 1305-78-8
Additional toxicological data
Administrative data
- Endpoint:
- additional toxicological information
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Test conducted according to the protocol for "Single Cell Gel/Comet Assay: Guidelines for In Vitro and In Vivo Genetic Toxicology Testing", Tice et al. (2000), but no metabolic activation system was used. With respect to the calcium fraction in CaMgO2, the test substance Ca(OH)2 can be considered as equivalent. Therefore, the results of the current study are supportive for lack of genotoxic effects of calcium released from CaMgO2. This information therefore fulfils Annex XI, point 1.5 of Regulation (EC) No 1907/2006.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Genetic damage in human peripheral lymphocytes exposed to antimicrobial endodontic agents
- Author:
- da Silva, G.N., et al.
- Year:
- 2 007
- Bibliographic source:
- Oral Surg. Oral Med. Oral Pathol. Oral Radiol. Endod. 104, e58-e61
Materials and methods
- Type of study / information:
- In vitro single cell gel electophoresis, mammalian cells
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: the protocol for "Single Cell Gel/Comet Assay: Guidelines for In Vitro and In Vivo Genetic Toxicology Testing"; Tice et al. (2000)
- Deviations:
- yes
- Remarks:
- no metabolic activation
- GLP compliance:
- no
Test material
- Reference substance name:
- Calcium dihydroxide
- EC Number:
- 215-137-3
- EC Name:
- Calcium dihydroxide
- Cas Number:
- 1305-62-0
- Molecular formula:
- CaH2O2
- IUPAC Name:
- calcium dihydroxide
- Details on test material:
- - Name of test material (as cited in study report): Calcium hydroxide (Biodinamica)
- Physical state: solid
No further data available.
Constituent 1
Results and discussion
Any other information on results incl. tables
No DNA breakage was detected after treatment of peripheral lymphocytes with calcium hydroxide at 100 µg/mL.
Applicant's summary and conclusion
- Conclusions:
- No DNA breakage was detected after treatment of peripheral lymphocytes with calcium hydroxide at 100 µg/mL. In summary, the results indicate that exposure to calcium hydroxide does not increase the level of DNA lesions in human peripheral lymphocytes as detected by single-cell gel (comet) assay.
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