Registration Dossier
Registration Dossier
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EC number: 238-692-3 | CAS number: 14643-87-9
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- Not reported
- 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:
- Unnamed
- Year:
- 1 983
Materials and methods
- Objective of study:
- distribution
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Distribution of zinc to different organs measured for up to 14 d after single oral administration of radiolabelled zinc chloride to male Wistar rats.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Zinc chloride
- EC Number:
- 231-592-0
- EC Name:
- Zinc chloride
- Cas Number:
- 7646-85-7
- Molecular formula:
- Cl2Zn
- IUPAC Name:
- zinc dichloride
- Details on test material:
- - Name of test material (as cited in study report): Zinc chloride
- Locations of the label (if radiolabelling): Zn
Constituent 1
- Radiolabelling:
- yes
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 240 g
- Diet: Granulated feed supplied by Bacutil and supplemented with white bred, milk and carrot.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Duration and frequency of treatment / exposure:
- Single administration
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.1 µCi (3.7 kBq) of Zn (65)
- No. of animals per sex per dose / concentration:
- 30
- Control animals:
- other: not applicable
- Positive control reference chemical:
- Not applicable
- Details on study design:
- No data
- Details on dosing and sampling:
- PHARMACOKINETIC STUDY (Distribution)
- Tissues and body fluids sampled: Stomach, small intestine, large intestine without its contents, liver, kidneys, lungs, spleen, testicle, prostate, brain, blood, heart, thigh muscles and hairs.
- Time and frequency of sampling: After 6 and 24 h and after 2, 4, 7, 14 d from the administration of radioisotope.
- Other: To avoid any losses of Zn (65), radioactivity of 1 g of each sample (1 mL of blood , whole heart, spleen and prostate) was immediately measured.
- Statistics:
- Student's t test
Results and discussion
- Preliminary studies:
- Not performed
Main ADME results
- Type:
- distribution
- Results:
- Highest accumulation in small intestine, liver, kidneys and large intestine; smaller amount in lungs and spleen; smallest amounts at nearly same level in brain, prostate, heart, blood, skin, hairs and gonads.
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Not measured
- Details on distribution in tissues:
- Highest accumulation in small intestine, liver, kidneys and large intestine; smaller amount in lungs and spleen; smallest amounts at nearly same level in brain, prostate, heart, blood, skin, hairs and gonads.
- Details on excretion:
- Not measured
Metabolite characterisation studies
- Metabolites identified:
- not measured
- Details on metabolites:
- Not applicable
Applicant's summary and conclusion
- Conclusions:
- In conclusion, zinc was mainly accumulated in small intestine, liver, kidneys and large intestine after single oral administration of zinc chloride to male Wistar rats.
- Executive summary:
A study was conducted to determine the distribution of zinc to different organs after oral administration of zinc chloride in rats.
30 male Wistar rats were intubated with 0.1 µCi (3.7 kBq) 65Zn as zinc chloride. Animals were sacrificed after 6 and 24 h and after 2, 4, 7, 14 d of administration and various organs viz. stomach, small intestine, large intestine without its contents, liver, kidneys, spleen, testicle, prostate, brain, blood, heart, thigh muscles and hairs were analysed for zinc concentration.
Zinc was accumulated in the highest amount within the small intestine, liver, kidneys and large intestine and in smaller amounts in lungs and spleen. The smallest amounts were found at nearly same level in brain, prostate, heart, blood, skin, hairs and gonads.
In conclusion, zinc was mainly accumulated in small intestine, liver, kidneys and large intestine after single oral administration of zinc chloride (Kossakowski, 1983).
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