Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Diss Factsheets
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: 262-309-9 | CAS number: 60580-61-2
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- 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
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 981
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Limit test:
- no
Test material
- Details on test material:
- - Name of test material: Zinc sulphate heptahydrate
- Substance type: Pure active substance
- Physical state: Crystal
- Analytical purity: 99.9 %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Shizuoka Agriculture Cooperative Association for Laboratory Animals
- Age at study initiation: Four wk
- Weight at study initiation: 120-150 g (male); 90-110 g (female)
- Fasting period before study: No data
- Housing: Stainless cages with a wire-meshed bottom
- Diet: Pulverized chows M (Oriental Yeast Co.), ad libitum, mixed with test material
- Water: Ad libitum
- Acclimation period: One wk
ENVIRONMENTAL CONDITIONS
- Temperature: 24±1 °C
- Humidity: 55±5 %
- Air changes (per hr): No data
- Photoperiod: 10 h dark/14 h light cycle
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: Mixed with basic feed
- Details on oral exposure:
- PREPARATION OF DOSING DIET:
DIET PREPARATION
- Rate of preparation of diet (frequency): No data
- Mixing appropriate amounts with (Type of food): Pulverized chows M
- Storage temperature of food: No data
- Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- 13 wk
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 300, 3000, 30000 ppm
Basis:
nominal in diet
- No. of animals per sex per dose:
- 12
- Control animals:
- yes, plain diet
- Details on study design:
- The animals were divided into four groups, each of which included 12 animals of each sex and fed on diets containing Zinc sulphate at
four different concentration levels 0, 300, 3,000 and 30,000 ppm, for 13 wk. - Positive control:
- No
Examinations
- Observations and examinations performed and frequency:
-
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Daily
BODY WEIGHT: Yes
- Time schedule for examinations: Weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: Yes
WATER CONSUMPTION: Yes
- Time schedule for examinations: Twice a wk
OPHTHALMOSCOPIC EXAMINATION: No data
- Time schedule for examinations: Not applicable
- Dose groups that were examined: Not applicable
HAEMATOLOGY: Yes
- Time schedule for collection of blood: No data
- Anaesthetic used for blood collection: Yes (under light ether anaesthesia)
- Animals fasted: No data
- How many animals: 48
- Parameters checked: Erythrocyte count, hemoglobin, leukocyte count, differential count of leukocyte
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: No data
- Animals fasted: No data
- How many animals: 48
- Parameters checked: Total plasma protein, alkaline phosphatase, glucose, urea nitrogen, SGOT, SGPT, cholesterol and calcium.
- Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
After necropsy at the termination of the study the following organs were weighed: Brain, pituitary, thyroid, heart, thymus, liver, kidney, spleen, adrenals, gonads (testes or ovaries), and muscles (triceps surae).
HISTOPATHOLOGY: Yes (see table)
- For histopathology following organs and tissues were collected: Brain, pituitary, thyroid, heart, thymus, liver, kidney, spleen, adrenals, gonads (testes or ovaries), and muscles (triceps surae), submaxillary glands, lungs, mesenteric lymph nodes, pancreas, stomach, small and large intestine, accessory genital organs, bone and bone marrow (sternum and femur), and lesions of gross abnormalities
- 3 or 4 µm paraffin sections from the specimens were stained with hematoxylineosin, periodic acid Schiff's reaction and azan for microscopic observations. - Other examinations:
- None
- Statistics:
- Student's t-test was used to estimate the statistical differences between controls and treated groups
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- effects observed, treatment-related
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- CLINICAL SIGNS AND MORTALITY:
- At 30,000 ppm: Showed symptom of discarding the diet from the food jar by picking it out with their fore-limbs. This symptom began a week
after commencement of the experiment and persisted throughout the study. No moribund animals of either sex were found.
- At ≤ 3,000 ppm: No remarkable signs in either sex. Two females, one of the control and one of the 3,000 ppm group, were killed in extremis due to suppurative pyelitis during the study.
BODY WEIGHT AND WEIGHT GAIN:
- At 30,000 ppm: Depressed weight gain and dwarfism. Weight gain of females in this group was slightly depressed during the study with significant
differences to control animals in the 1st to 5th wk of the study.
- At ≤ 3,000 ppm: Statistically not significant values when compared to control
FOOD & WATER CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- At 30,000 ppm: Food intake of males decreased after the third wk of the study. A similar reduction was seen in females of this group during the 1st to 6th wk but then disappeared. A slightly lower value of average food and water intake was reported only in males.
- At ≤ 3,000 ppm: Statistically not significant values when compared to control
FOOD EFFICIENCY:
There were some fluctuations in food efficiency in each group.
- At 30,000 ppm: Slight reduction in overall average value.
- At ≤ 3,000 ppm: Statistically not significant values when compared to control
HAEMATOLOGY:
-At 30,000 ppm: A moderate reduction in leukocyte count was shown in both sexes. Males showed a slight decrease in hematocrit and hemoglobin concentration.
- At 3,000 ppm: No remarkable changes in animals but there was a slight increment of hemoglobin concentration in females
CLINICAL CHEMISTRY:
Significant reductions or reductive tendencies were seen in rats in the following parameters: SGOT and SGPT in all male groups, total protein, cholesterol and calcium levels in males in the 30,000 ppm group and calcium level in females in both the 3,000 and 30,000 ppm groups.
ORGAN WEIGHTS:
-At 30,000 ppm: A slight or moderate decrease in absolute and relative weights was seen in the liver and kidney among males
- Significant fluctuations of absolute or relative organ weights were seen in various organs from chemically treated groups of both species, no clear relationship with the treatment could be shown.
- At ≤ 3,000 ppm: Statistically not significant values when compared to control
GROSS PATHOLOGY
No remarkable lesions were attributable to the treatment.
HISTOPATHOLOGY: NON-NEOPLASTIC
- At 30,000 ppm: Pancreatic lesions as well as degeneration and necrosis of the acinar cells, clarification of centroacinar cells and interstitial fibrosis. No other lesions attributable to the treatment.
- No histopathological abnormalities were observed in the bone or male genital organs which had elsewhere been reported to have sustained toxic changes due to an overdose of Zinc.
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- 3 000 ppm
- Sex:
- male/female
- Basis for effect level:
- other: No remarkable clinical signs in either sex at ≤ 3000 ppm diet admix, approximately equivalent to 234 mg/kg/day (~53.5 mg Zn2+/kg bw/day) (male) and 243 mg/kg/day (female)
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
See the attached pdf for the following figure and tables:
Fig. 2. Group mean body weights in rats
Table 2. Food, chemical, water intake and food efficiency in rats
Table 4. Hematology-mean values in rats.
Table 6. Blood biochemistry--mean values in rats
Table 8. Absolute and relative organ weights in rats
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions, NOEL of the test material in rats was determined to be 3,000 ppm (approximately equivalent to 234 mg/kg/day in male rats and 243 mg/kg/day in female rats)
- Executive summary:
This study was conducted to evaluate the subchronic toxicity (13 wk) of the test material in Wister rats. The study followed was equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents).
Rats of both sexes were fed a diet containing the test material at 0, 300, 3,000 and 30,000 ppm for 13 wk. The clinical signs of the animals, body weight, food, chemical and water intake, food efficiency, hematological, biochemical examination, necropsy and organ weight and histopathological examination were performed.
Animals in the 30,000 ppm group showed retarded growth along with low food intake, abnormal values in a few hematological parameters and regressive changes of the pancreatic exocrine gland. There were no remarkable clinical signs in either sex in groups ≤ 3,000 ppm.
Under the test conditions, NOEL of the test material in rats was determined to be 3000 ppm (approximately equivalent to 234 mg/kg/day in male rats and 243 mg/kg/day in female rats).
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)
Embora a ECHA disponibilize muito material em linha na sua língua, uma parte desta página está disponível apenas em inglês. Mais informações sobreas práticas de multilinguismo da ECHA.
Bem-vindo ao sítio Web da ECHA O navegador Internet Explorer 7 (e versões anteriores) não é totalmente suportado por este sítio Web. Por favor atualize o seu Internet Explorer para uma versão mais recente.
Este sítio Web utiliza cookies a fim de garantir a melhor experiência possível nos nossos sítios Web.
Saiba mais sobre como utilizar cookies.