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EC number: 293-048-9 | CAS number: 91051-00-2
- 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
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Toxicity to reproduction
Administrative data
- Endpoint:
- one-generation reproductive toxicity
- Remarks:
- based on generations indicated in Effect levels (migrated information)
- 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
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:
- 1 986
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Males rats were fed diet supplemented with the test material for specific period and then mated with normal females. Males were sacrificed after mating and effect on sperm motility/viability and zinc concentration in reproductive organs observed. Females were allowed to have full term gestation and effect on conception and litter viability were determined.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Zinc sulphate
- EC Number:
- 231-793-3
- EC Name:
- Zinc sulphate
- Cas Number:
- 7733-02-0
- Molecular formula:
- H2O4S.Zn
- IUPAC Name:
- zinc sulfate
- Details on test material:
- - Name of test material (as cited in study report): Anhydrous zinc sulphate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Charles-Foster
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: (P) Males: 162 g
- Diet: Crushed rat feed of Hindustan Lever (India); ad libitum
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- DIET PREPARATION
- Mixing appropriate amounts with (Type of food): Crushed rat feed - Details on mating procedure:
- - M/F ratio per cage: 1:1
- Length of cohabitation: 1 d
- Proof of pregnancy: Sperm in vaginal smear (mating performed only once irrespective of results) - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- 30-32 d before mating to males only
- Frequency of treatment:
- Daily, ad libitum
- Details on study schedule:
- Following the day of mating, males were sacrificed and sperm was immediately collected from epididymis for motility and viability studies. Reproductive organs were dissected out for estimation of zinc. Mated females were allowed to have full term gestation.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
4,000 ppm zinc as zinc sulphate
Basis:
nominal in diet
- No. of animals per sex per dose:
- Control group: 15
Treatment group: 18 - Control animals:
- yes, plain diet
- Details on study design:
- None
- Positive control:
- None
Examinations
- Parental animals: Observations and examinations:
- No data
- Oestrous cyclicity (parental animals):
- No data
- Sperm parameters (parental animals):
- Parameters examined in male parents:
Sperm motility and viability - Litter observations:
- PARAMETERS EXAMINED
The following parameters were examined in F1 offspring:
Number of pups, stillbirths, live births and malformation
- Postmortem examinations (parental animals):
- - Male animals: All animals sacrificed following the day of mating and reproductive organs (testis, epididymis, seminal vesicle and prostate) were dissected out for estimation of zinc
- Maternal animals: Not sacrificed - Postmortem examinations (offspring):
- No data
- Statistics:
- Fischer's one sided T test
- Reproductive indices:
- None
- Offspring viability indices:
- None
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- effects observed, treatment-related
- Reproductive performance:
- effects observed, treatment-related
Details on results (P0)
REPRODUCTIVE PERFORMANCE (PARENTAL ANIMALS): Mating by zinc treated males caused significant lowering of incidence of conception and number of live births per mated female. Only 11 females conceived out of 18 mated by zinc treated males whereas all females mated with control rats conceived. (See Table 1 for details)
OTHER FINDINGS (PARENTAL ANIMALS): Zinc content was significantly increased only in the testis (25 %) and sperm (18 %) of the zinc treated rats. (See Table 2 for details)
Effect levels (P0)
open allclose all
- Dose descriptor:
- dose level: 4,000 ppm zinc
- Sex:
- male
- Basis for effect level:
- other: overall effects sperm characterization; other: zinc concentration in reproductive organs
- Remarks on result:
- not measured/tested
- Remarks:
- Effect level not specified (migrated information)
- Dose descriptor:
- other: Not treated but mated with males fed 4,000 ppm zinc
- Sex:
- female
- Basis for effect level:
- other: Overall effects incidence of conception
- Remarks on result:
- not measured/tested
- Remarks:
- Effect level not specified (migrated information)
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
Details on results (F1)
OTHER FINDINGS (OFFSPRING): No malformed litter in any of the groups
Effect levels (F1)
- Dose descriptor:
- other: Offsprings of 4,000 ppm zinc treated males
- Generation:
- F1
- Sex:
- male/female
- Basis for effect level:
- other: overall effects live births; offspring malformation
- Remarks on result:
- not measured/tested
- Remarks:
- Effect level not specified (migrated information)
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Table 1: Outcome of mating by zinc treated male rats
|
Mating males |
|
|
Control |
Experimental |
Number of females mated |
15 |
18 |
Number of females conceived |
15 |
11 |
Normal live litter |
||
Total number |
101 |
61 |
Number / mated female |
6.73 |
3.38* |
*Difference was significant at 5% level
Table 2: Zinc content of the reproductive tissues of zinc treated male rats
|
Control |
Experimental |
Testis |
28.1± 1.63 (15) |
35.3 ± 2.13 (18)* |
Epididymis |
58.3 ± 3.46 (10) |
61.4 ± 6.63 (10) |
Seminal vesicle |
24.4 ± 3.25 (10 |
33.8 ± 5.96 (10) |
Prostate (whole) |
48.8 ± 6.90 (10) |
51.7 ± 6.36 (10) |
Sperm |
559 ± 14.8 (10) |
658 ± 24.7 (10)* |
Results expressed as Mean ± SEM in µg/g, except for sperm in µg/g dw, for the number of
rats shown in parentheses.
* P < 0.02
Table 3: Motility and viability of the sperm of zinc treated rats
|
Control (15) |
Experimental (18) |
Motility (Emmen's unit) |
|
|
30 min |
25.9 ± 0.57 |
23.7 ± 0.47* |
2 hours |
23.7 ± 0.58 |
17.7 ± 1.15** |
4 hours |
17.2 ± 1.10 |
12.2 ± 1.42* |
% viable at 4 hours |
55.7 ± 4.80 |
49.0 ± 4.60 |
Values expressed as Mean ± SEM for the number of rats shown in parentheses.
* P < 0.01
**P < 0.001
Applicant's summary and conclusion
- Conclusions:
- Dietary zinc supplementation at 4,000 ppm reduced male fertility in rats under the conditions of the study.
- Executive summary:
A study was conducted to determine the effects of dietary zinc supplementation on male fertility in Charles-Foster rats.
4,000 ppm zinc as zinc sulphate was fed to 18 test males in diet for 30 -32 d. 15 control males were fed normal diet for the same duration. All animals mated with individual normal females once between Day 30 and 32. After mating, males were sacrificed for sperm characterization and zinc concentration analysis in different reproductive organs. Mated females were allowed to have full term gestation.
Mating by treated males caused significant lowering of incidence of conception and number of live births per mated female. However, no stillbirth or malformed litter was observed. Motility of the sperm was significantly reduced in the treated rats but viability was unaffected. Zinc content was significantly increased only in the testis and sperm of the treated rats.
The results indicate that dietary zinc supplementation at 4,000 ppm reduced male fertility in rats under the conditions of the study.
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