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Diss Factsheets
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EC number: 910-704-8 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- chronic toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The test substance of the study is calcium hydroxide, however the results are supporting also information on "Reaction mass of limestone and dicalcium silicate", in which calcium hydroxide is the main constituent governing the toxicological properties
Data source
Reference
- Reference Type:
- publication
- Title:
- Systemic and local effects of long-term exposure to alkaline drinking water in rats
- Author:
- Merne, M.E.T.; et al.
- Year:
- 2 001
- Bibliographic source:
- Int. J. Exp. Path 82, 213-219
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Groups of Long-Evans rats (6 animals of each sex) received drinking water supplemented with Ca(OH)2 and adjusted to pH 11.2 or 12.0 for 52 weeks. The same number of animals served as control.
- GLP compliance:
- not specified
- Limit test:
- 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
No further details are given.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Long-Evans
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: In groups 1, 2 and 3 the experiment was started when the rats were 12 weeks old, and in groups 4, and 5 at the age of 6 weeks.
- Housing: rats were housed in solid-polycarbonate bottom metal cages with alderwood bedding in groups of three
- Diet: ad libitum; standard laboratory animal feed (SDS, RM3; essex, UK)
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): 45-55
- Photoperiod: 12 hours dark/light cycle
No further details are given.
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
- Exposure group 2 and 4: Calcium dihydroxide was used to raise water pH (adjusted to pH 11.2 or 12.0, measured using a pH meter)
- Exposure group 3 and 5: NaOH was used to raise water pH (adjusted to pH 11.2 or 12.0, measured using a pH meter) - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- no data
- Duration of treatment / exposure:
- 52 weeks
- Frequency of treatment:
- continuously
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
Ca(OH)2 to achieve pH 11.2
Basis:
nominal in water
- Remarks:
- Doses / Concentrations:
Ca(OH)2 to achieve pH 12
Basis:
nominal in water
- Remarks:
- Doses / Concentrations:
pH 7 (untreated/ control)
Basis:
nominal in water
- No. of animals per sex per dose:
- 48 rats were divided into 4 study groups (group 2-5) and 1 control group (group 1).
Group 1 to 3: 6 male and 6 female rats, respectively.
Group 4 and 5: 3 male and 3 female rats, respectively. - Control animals:
- yes
- Positive control:
- no data
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
All animals were weighed at the completion of the experiment.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
FOOD EFFICIENCY: No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes
- Time schedule for examinations: Water intake was monitored intermittently in all groups.
OPHTHALMOSCOPIC EXAMINATION: No data
HAEMATOLOGY: No data
CLINICAL CHEMISTRY: No data
URINALYSIS: No data
NEUROBEHAVIOURAL EXAMINATION: No data - Sacrifice and pathology:
- - After completion of the study, the rats were killed using carbon dioxide, and necropsy samples were taken from the oral buccal mucosa, palate, tongue, oesophargus, stomach, intestines, liver and kidneys.
- In group 4 and 5, additional samples were obtained from the salivary glands, masseter muscle, thyroid, hypothalamus and ovary or testes.
GROSS PATHOLOGY: No data
HISTOPATHOLOGY: Yes
- Tissues samples (as stated above) were subjected to histopathological examination. Samples were fixed in 10 % neutral formalin, embedded in paraffin, cut into 5-μm sections and stained with
haematoxylin and eosin for routine light microscopic evaluation.
- For immunohistochemistry (IHC), formalin-fixed, paraffin-embedded samples were sectioned to 5-μm thickness and mounted on organosilan-coated slides.
- Sections were stained using the avidin-biotin complex technique and an automatic appliance, according to the manufacturer's instructions.
- Antibodies used were pankeratin, cytokeratin (CK) 19, CK5, CK4, proliferating cell nuclear antigen (PCNA), intercellular adhesion molecule-1 (ICAM-1), CD44, CD68 and S-100, as well as heat shock
protein (HSP) 60, HSP 70 and HSP 90.
- Oral mucosa biopsy samples were also subjected to immunohistochemical analysis of the expression of a number of proteins regulating keratinocyte differentiation, cell proliferation, cell adhesion, and cell
stress. - Other examinations:
- no data
- Statistics:
- no data
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- CLINICAL SIGNS AND MORTALITY
- All animals survived the experiment and remained in good condition until the end of the experiment.
BODY WEIGHT AND WEIGHT GAIN
- At the study end, animals in the exposed groups had lower body weights (up to 29 % less) than controls despite equal food and water intake, suggesting a systemic response to the alkaline treatment.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study)
- Food intake was equal in the study and control rats.
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study)
- No differences between the groups were observed.
HISTOPATHOLOGY: NON-NEOPLASTIC
- The epithelium of the oral buccal mucosa, palate, and tongue of the rats from the study groups was similar in morphology and structure to that of controls.
- No defined mucosal atrophy or ulcerations were observed. In samples obtained from extra-oral tissues, no marked changes were seen after alkaline exposure.
- Alkaline exposure did not affect cell proliferation in the oral epithelium. The up-regulation of HSP70 protein expression in the oral mucosa of Ca(OH)2 exposed rats may indicate a protective response
against alkaline water. Intracellular adhesion molecule-1 (ICAM-1) positivity was lost in 6/12 and 0/6 rats treated with Ca(OH)2 at pH 11.2 and 12, respectively. A loss in CD44 expression was seen in the
study groups exposed to alkaline water with pH 12.
Effect levels
- Dose descriptor:
- NOAEL
- Basis for effect level:
- other: The study is not appropriate for derivation of a NOAEL.
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The results suggest that the oral mucosa of rats is resistant to the effects of highly alkaline drinking water. However, high alkalinity may have some unknown systemic effects leading to growth retardation. The study is not appropriate for derivation of a NOAEL.
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