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EC number: 238-687-6 | CAS number: 14639-97-5
- 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
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Carcinogenicity
Administrative data
Description of key information
No adequate experimental animal studies are available to evaluate the carcinogenicity of zinc compounds in humans.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Carcinogenic potential of the test material added in drinking water was evaluated in mice in a one year study.
- GLP compliance:
- not specified
- Species:
- mouse
- Strain:
- other: Chester Beatty stock
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Newly-born litters
- Housing: 4-6 per metal cage
- Diet: Basic diet (prepared from a meal-mix supplied by Messrs. Dixon, of Ware, Herts., to which "Bemax" stabilised wheat germ (Vitamins Ltd., Crawley, Sussex), arachis oil (British Pharmacopoeia Standard, from Savory and Moore Ltd., London) and Vitamin A and D concentrates (British Drug Houses Ltd., Poole, Dorset) were added.
The basic diet had the following percentage composition: meal-mix (wheat flour, 68.7; casein, 11.4; milk powder, 8.0; chalk, 1.3; salt mixture, 0.8; andyeast, 2.3); "Bemax" stabilised wheat germ containing carbohydrates, protein, B vitamins, manganese, iron, copper, essential amino acids, 2.5; arachisoil and vitamins A (40,000 I.U.) and D (4,000 I.U.) concentrate 5.0. - Route of administration:
- oral: drinking water
- Type of inhalation exposure (if applicable):
- other: Not applicable
- Vehicle:
- water
- Details on exposure:
- VEHICLE
- Concentration in vehicle: 22 g/L and 4.4 g/L - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- Not applicable
- Duration of treatment / exposure:
- 1 year
- Frequency of treatment:
- Daily
- Post exposure period:
- No
- Remarks:
- Doses / Concentrations:
22 g/L (5000 ppm zinc)
Basis:
nominal in water - Remarks:
- Doses / Concentrations:
4.4 g/L (1000 ppm zinc)
Basis:
nominal in water - No. of animals per sex per dose:
- No data
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data
- Positive control:
- No data
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Once a wk throughout the experiment and daily when fed
BODY WEIGHT: Yes
- Time schedule for examinations: Once in 2 wk
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: No
CLINICAL CHEMISTRY: No
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes, lesions were examined histopathologically. Stomachs were fixed with formol saline and examined for tumours and other changes in the forestomach and glandular epithelium. - Other examinations:
- None
- Statistics:
- No data
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- BODY WEIGHT AND WEIGHT GAIN: No appreciable difference was observed between the treatment and control groups.
HISTOPATHOLOGY: NON-NEOPLASTIC
There were no difference between the treated groups and control regarding the incidence of forestomach epithelial hyperplasia.
HISTOPATHOLOGY: NEOPLASTIC
Incidences of hepatoma, malignant lymphoma and long adenoma observed in the treated mice were similar to the control groups. There were no sex difference between the incidence of tumour observed in the treated groups. - Relevance of carcinogenic effects / potential:
- No differences in carcinogenic effects were observed between treatment and control groups under the test conditions.
- Dose descriptor:
- NOAEL
- Effect level:
- > 22 000 mg/L drinking water
- Sex:
- male/female
- Basis for effect level:
- other: overall effects
- Remarks on result:
- other: Effect type: carcinogenicity (migrated information)
- Conclusions:
- Under the test conditions, the test material was found to be non-carcinogenic in mice.
- Executive summary:
A study of one-year duration was conducted to evaluate the carcinogenic potential of the test material in mice.
Chester Beatty stock mice (newly-born litters) were used. They were housed in the metal cages (4-6 per cage). The doses of zinc sulphate were 22 g/L (5,000 ppm zinc) and 4.4 g/L (1,000 ppm zinc) in drinking water along with a control group fed a basal diet and normal drinking water. The animals were examined thoroughly once a wk throughout the experiment and daily when fed. Weighing was done once every 2 wk. Deaths of animals occurred during the first 8 wk of experiment due to an epizootic of ectromelia. The survivors were vaccinated with sheep lymph and animals showing a negative or accelerated response were sacrificed. New group of weanling mice (4 -5 wk old) were added to supplement the control group. All the surviving animals were sacrificed after 1 year of treatment and examined for gross pathology. Histopathological examination was done for suspected neoplastic lesions. Stomachs were examined for tumours and other changes in the forestomach and glandular epithelium.
No differences in carcinogenic effects were observed between treatment and control groups under the test conditions.
Under the test conditions, the test material was found to be non-carcinogenic in mice.
Reference
Table 1: Incidence and types of tumours in mice surviving 45 wk of treatments
Group | No. of mice killed during weeks 45-53 | No. of mice with | ||
Hepatoma | Malignant lymphoma | Lung adenoma | ||
22 g ZnSO4/L (5000 ppm Zn) | 22 | 3 | 2 | 5 |
4.4 g ZnSO4/L (1000 ppm Zn) | 28 | 3 | 4 | 9 |
Control | 19 | 1 | 2 | 8 |
5 | 2 | 1 | 2 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Study duration:
- chronic
- Species:
- mouse
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
On the basis of the existing information it can be concluded that there is no conclusive evidence for carcinogenic activity of any of the zinc compounds considered in this chemical safety report.
Additional information
There are a range of epidemiological studies that investigated the association between zinc exposure either through occupational activities or food supplementation and increased cancer risks. While no associations were found between occupational zinc exposure and excess cancer risk, the main association that has been made in this context is related to dietary/supplemental zinc and prostate cancer risk.
In contrast to established clinical and experimental evidence that prostate cancer is associated with a decrease in the zinc uptake, numerous epidemiology studies and reports of the effect of dietary and supplemental zinc on the incidence of prostated cancer have provided divergent, inconsistent and inconclusive results which range from adverse effects of zinc, protective effects of zinc and no effect of zinc on the risk of prostate cancer. Clinical and experimental studies have established that zinc levels are decreased in prostate cancer and support a role of zinc as a tumor suppressor agent. Malignant prostate cellsin situ are incapable of accumulating high zinc levels from circulation (Franklinet al.,2005; Costello and Franklin, 2006; Franklin and Costello, 2007).
In a recent critical assessment of epidemiology studies regarding dietary/supplemental zinc and prostate cancer risk, Costello et al.,concluded that epidemiological studies have not provided an established relationship for any effect or lack thereof of dietary/supplemental zinc on the risk of prostate cancer. Proclamations of an association of dietary/supplemental zinc and increased prostate cancer are based on inconclusive and uncorroborated reports (Costello et al.,2007).
Justification for selection of carcinogenicity via oral route endpoint:
only 1 experimental animal study available but several epidemiological studies regarding dietary/supplental zinc and prostated cancer are available, however, not providing an established association of dietary/supplemental zinc and increased prostate cancer
Justification for selection of carcinogenicity via inhalation route endpoint:
no experimental animal study available but several epidemiological studies indicating no association between occupational zinc exposure and excess cancer risk
Carcinogenicity: via oral route (target organ): digestive: stomach; urogenital: prostate
Carcinogenicity: via inhalation route (target organ): respiratory: lung
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.
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