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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 946-329-1 | 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
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Increment of Immune Responses in Mice Perinatal Stages After Zinc Supplementation
- Author:
- Lastra, M. D, Pastelin, R., Herrera, M. A., Orihuela, V. D., Aguilar, A. E.
- Year:
- 1 997
- Bibliographic source:
- Archives of Medical Research, Vol 28, 99 67-72, 1997
Materials and methods
- Principles of method if other than guideline:
- Mice received zinc acetate in drinking water at concentrations of 500 and 1000 mg/I during the periods of gestation, lactation and postweaning. The general appearance, growth curves and hematocrit were examined in treated animals.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Zinc di(acetate)
- EC Number:
- 209-170-2
- EC Name:
- Zinc di(acetate)
- Cas Number:
- 557-34-6
- IUPAC Name:
- zinc diacetate
Constituent 1
- Specific details on test material used for the study:
- supplier: Mallinckrodt, cat. no. 8740
Test animals
- Species:
- mouse
- Strain:
- Balb/c
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Laboratory of Immunology at the School of Chemistry of the Natioal University of Mexico
- Age at study initiation: (P) 6 wks
- Weight at study initiation: (P) Females: approximately 22 g;
- Fasting period before study: not specified
- Housing: Plastic cages equipped with steel covers and sterile sawdust on the floor were used.
- Diet: ad libitum (Blue-Bonnet, 2000 Biomex)
- Water (e.g. ad libitum): not specified
- Acclimation period: not specified
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Details on mating procedure:
- After mating, the males were separated from the females. The pregnant females were housed individually.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- One group of female, pregnant mice were exposed to Zn Acetate during gestation and lactancy. Another group of female, pregnant mice were exposed to Zn Acetate during gestation, lactancy and post-weaning.
- Frequency of treatment:
- daily with drinking water
Doses / concentrationsopen allclose all
- Dose / conc.:
- 500 ppm
- Remarks:
- Zinc
- Dose / conc.:
- 1 000 ppm
- Remarks:
- Zinc
- No. of animals per sex per dose:
- 30 animals per group
- Control animals:
- yes
Examinations
- Litter observations:
- STANDARDISATION OF LITTERS
- Litter: 6 to 8 pups/litter; amount of pups adjusted to 6 per litter.
PARAMETERS EXAMINED
The following parameters were examined in F1 offspring: number of pups, stillbirths, live births, presence of gross anomalies, physical abnormalities, growth curves.
- Statistics:
- ANOVA with p value < 0.05 was considered significant.
- Reproductive indices:
- 6 to 8 pups/litter
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- not examined
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Body weight and weight changes:
- not examined
- 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:
- effects observed, treatment-related
- Description (incidence and severity):
- "The hematocrit values were slightly reduced in the groups that received 1000 mg/l both after 21 and 42 days."
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- "The concentration of Zn remained constant over the first 21 days,increasing significantly during the post-weaning period. An increasing tendency was observed in the treated mice at 42 days of age, the period in which thymic involution is observed in the controls."
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- effects observed, non-treatment-related
- Description (incidence and severity):
- "A similar reproductive index was observed between the treated animals and the control group."
"The excess of zinc did not seem to alter the viability, the offspring number, or neonatal mortality."
Effect levels (P0)
open allclose all
- Dose descriptor:
- conc. level: see 'Remarks'
- Remarks:
- test concentration
- Effect level:
- 500 mg/L drinking water
- Based on:
- element
- Sex:
- female
- Basis for effect level:
- haematology
- clinical biochemistry
- reproductive performance
- other: immunological findings
- Dose descriptor:
- conc. level: see 'Remarks'
- Remarks:
- test concentration
- Effect level:
- 1 000 mg/L drinking water
- Based on:
- element
- Sex:
- female
- Basis for effect level:
- haematology
- clinical biochemistry
- reproductive performance
- other: immunological findings
- Dose descriptor:
- conc. level: see 'Remarks'
- Remarks:
- test concentration
- Effect level:
- 28.57 mg/kg bw/day
- Based on:
- element
- Sex:
- female
- Basis for effect level:
- haematology
- clinical biochemistry
- reproductive performance
- other: immunological findings
- Remarks on result:
- other: converted to mg/kg bw/day (please refer to 'Any other information on results incl. tables'
- Dose descriptor:
- conc. level: see 'Remarks'
- Remarks:
- test concentration
- Effect level:
- 57 mg/kg bw/day
- Based on:
- element
- Sex:
- female
- Basis for effect level:
- haematology
- clinical biochemistry
- reproductive performance
- other: immunological findings
- Remarks on result:
- other: converted to mg/kg bw/day (please refer to 'Any other information on results incl. tables'
Results: P1 (second parental generation)
Effect levels (P1)
- Remarks on result:
- not measured/tested
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not examined
- Dermal irritation (if dermal study):
- not examined
- Mortality / viability:
- no mortality observed
- Description (incidence and severity):
- "The excess of zinc did not seem to alter the viability, the offspring number, or neonatal mortality."
- Body weight and weight changes:
- not examined
- 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
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Histopathological findings:
- not examined
- Other effects:
- no effects observed
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not examined
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- effects observed, treatment-related
- Description (incidence and severity):
- "Indirect plaque forming cells (IgG) did not show any significant response to Zn treatment."
"A significant increase in lymphocytes proliferation from mice treated with doses of 500 mg/l and 1000 mg/l with respect to control mice at the end of lactancy (21 days) (p<0.05).A significant reduction in the proliferation was also observed in mice 42 days old, treated with 500 and 1000 mg/l doses."
Effect levels (F1)
open allclose all
- Dose descriptor:
- conc. level: see 'Remarks'
- Remarks:
- test concentration
- Generation:
- F1
- Effect level:
- 500 mg/L drinking water
- Based on:
- element
- Sex:
- male/female
- Basis for effect level:
- viability
- mortality
- developmental immunotoxicity
- Dose descriptor:
- conc. level: see 'Remarks'
- Remarks:
- test concentration
- Generation:
- F1
- Effect level:
- 1 000 mg/L drinking water
- Based on:
- element
- Sex:
- male/female
- Basis for effect level:
- viability
- mortality
- developmental immunotoxicity
- Dose descriptor:
- conc. level: see 'Remarks'
- Remarks:
- test concentration
- Generation:
- F1
- Effect level:
- 28.57 mg/kg bw/day
- Based on:
- element
- Sex:
- male/female
- Basis for effect level:
- viability
- mortality
- developmental immunotoxicity
- Remarks on result:
- other: converted to mg/kg bw/day (please refer to 'Any other information on results incl. tables')
- Dose descriptor:
- conc. level: see 'Remarks'
- Remarks:
- test concentration
- Generation:
- F1
- Effect level:
- 57 mg/kg bw/day
- Based on:
- element
- Sex:
- male/female
- Basis for effect level:
- viability
- mortality
- developmental immunotoxicity
- Remarks on result:
- other: converted to mg/kg bw/day (Please refer to 'Any other information on results incl. tables')
Target system / organ toxicity (F1)
- Critical effects observed:
- no
Results: F2 generation
Effect levels (F2)
- Remarks on result:
- not measured/tested
Overall reproductive toxicity
- Reproductive effects observed:
- no
Any other information on results incl. tables
Dose calculation
500 mg/L Zn in drinking water/day = 0.5 g Zn/g water
default values for dose calculation for female rats (according to Golde et al., 1984 and Paulussen et al., 1998, cited in ECHA Guidance R.8)
water consumption per day (female rat) = 20 mL
body weight (female rat) = 0.35 kg
Zn intake per rat per day
0.5 mg Zn/g water/day x 20 g = 10 mg Zn/day
Zn intake per body weight/day
(10 mg Zn/day) / 0.35 kg = 28.57 mg/kg bw/day
conversion factor = 0.057
Applicant's summary and conclusion
- Conclusions:
- No changes were observed in the general appearance, growth curves, hematocrit or signs of achromotrichia between treated and control animals. Group II and III showed a significant increase in 3H-thymidine-determined splenic lymphoproliferation, while groups V and VI exhibited an important decrease. A significant increase in plaque - forming cell response (IgM) was observed after the period of lactation in groups II and III as well as in groups V and VI. Zinc concentrations determined by atomic absorption in liver and thymus were significantly higher in all treated mice 42 days after birth. Results suggest that for carefully monitored periods and doses, oral zinc supplements might have a beneficial effect over some immune responses in the perinatal stages.
- Executive summary:
In this study mice received zinc acetate in drinking water at concentrations of 500 and 1000 mg/I during the periods of gestation, lactation and post-weaning. The sequence employed in this study was (gestation/lactation/post-weaning): (I) 0/0 (II) 500/500 (III) 1000/1000 (IV) 0/0/0 (V) 500/500/500 and (VI) 1000/1000/1000 with their respective controls. Each group consists of 30 animals. No changes were observed in the general appearance, growth curves, hematocrit or signs of achromotrichia between treated and control animals. Group II and III showed a significant increase in 3H-thymidine-determined splenic lymphoproliferation, while groups V and VI exhibited an important decrease. A significant increase in plaque - forming cell response (IgM) was observed after the period of lactation in groups II and III as well as in groups V and VI. Zinc concentrations determined by atomic absorption in liver and thymus were significantly higher in all treated mice 42 days after birth. Results suggest that for carefully monitored periods and doses, oral zinc supplements might have a beneficial effect over some immune responses in the perinatal stages.
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.