Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 215-137-3 | CAS number: 1305-62-0
Carcinogenicity
Administrative data
- Endpoint:
- carcinogenicity
- Remarks:
- other: topical application (not further specified)
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given. Only liver, stomach, cheek pouches and kidneys were examined.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Histopathology of hamster cheek and liver following topical application of lime
- Author:
- Agrawal RC, Sarode AV and Bhide SV
- Year:
- 1 986
- Bibliographic source:
- Indian J Med Res 84: 542-547
- Reference Type:
- secondary source
- Title:
- Histopathology of hamster cheek and liver following topical application of lime
- Author:
- Agrawal RC, Sarode AV and Bhide SV
- Year:
- 1 986
- Bibliographic source:
- cited in: Consensus Report for Calcium Oxide and Calcium Hydroxide, February 24, 1999
Materials and methods
- Principles of method if other than guideline:
- Method: no data
- GLP compliance:
- not specified
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): Shell lime (calcium hydroxide)
- Analytical purity: no data given
Constituent 1
Test animals
- Species:
- hamster
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Route of administration:
- other: topical application (not further specified)
- Vehicle:
- not specified
- Duration of treatment / exposure:
- 14 months
- Frequency of treatment:
- 5 d/week
- Post exposure period:
- no data given
Doses / concentrations
- Remarks:
- Doses / Concentrations:
4 mg per animal
Basis:
nominal conc.
- No. of animals per sex per dose:
- Lime: 16 animals
Control (untrated): 25 animals - Control animals:
- not specified
- Details on study design:
- Animals were killed only when moribund.
Dead or killed animals were carefully observed for any gross abnormalities.
Liver, stomach, cheek pouch and kidney were fixed in 10 per cent neutral formalin and the tissues were processed for histopathological studies; 6 µm thick paraffin sections were cut and stained with haematoxylin and eosin and carefully observed under the microscope. Tissues of some animals could not be studied due to autolysis und cannibalism in hamsters.
Results and discussion
Results of examinations
- Details on results:
- According to the authors, the animals showed hyperplasia and papillary formations in oral mucosa.
Lime alone:
Sixteen cheek pouches were studied for histopathology of which 3 were normal and 3 had mild epithelial hyperplasia. Early papillary formation in eight, and advancing papillary formation in two animals were seen.
The liver of the treated animals showed necrosis (5/14), fibrosis (5/14) or cirrhosis (3/14).
Untreated control:
Of the 25 cheek pouches observed 19 were normal. Mild hyperplasia in two and early papillary formation in four were seen.
The liver of the control animals showed necrosis (3/31), fibrosis (7/31) or cirrhosis (3/31).
Effect levels
- Dose descriptor:
- NOAEL
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
