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Toxicological information

Additional toxicological data

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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:
2007
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

Constituent 1
Chemical structure
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.

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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