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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 CaCO3.MgO, 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 CaCO3.MgO (calcined dolomite). 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:
Genotoxicity of antimicrobial endodontic compounds by single cell gel (comet) assay in chinese hamster ovary (CHO) cells
Author:
Ribeiro, D.A.; et al.
Year:
2005
Bibliographic source:
Oral. Surg. Oral. Med. Oral Pathol Oral Radiol. Endod. 99: 637-640

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 was used
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Calcium dihydroxide
EC Number:
215-137-3
EC Name:
Calcium dihydroxide
Cas Number:
1305-62-0
IUPAC Name:
calcium dihydroxide
Details on test material:
- Name of test material (as cited in study report): Calcium hydroxide
- Physical state: solid
No further details are given.

Results and discussion

Any other information on results incl. tables

Calcium hydroxide did not contribute to DNA damage at all concentrations tested.

Applicant's summary and conclusion

Conclusions:
There is no indication of any potential for DNA damage of calcium hydroxide in this study.

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