Registration Dossier

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: 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.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Lack of genotoxicity of formocresol, paramonocholorphenol, and calcium hydroxide on manmmalian cells by comet assay
Author:
Ribeiro, D.A.; et al.
Year:
2004
Bibliographic source:
J. Endodontics, Vol. 30, No. 8, 593-596

Materials and methods

Type of study / information:
In vitro single cell gel electophoresis, mammalian cells
Test guideline
Qualifier:
according to
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

Reference
Name:
Unnamed
Type:
Constituent
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 had no detectable effect on the two parameters of genotoxicity (tail moment and tail intensity).

Applicant's summary and conclusion

Conclusions:
Calcium hydroxide had no detectable effect on the two parameters of genotoxicity (tail moment and tail intensity).