Fatty acids, tallow, zinc salts

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

other information

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study well documented, meets generally accepted scientific principles, acceptable for assessment, reference in EU risk assessment for zinc oxide 2004

Data source

Reference

Reference Type:

publication

Title:

Intake and distribution of zinc in rat organisms after zinc oxide inhalation in male and female animals.

Author:

Pistorius D, Rosmanith J & Breining H

Year:

1976

Bibliographic source:

Beitr Silikose Forsch (Pneumokon) 28: 92-101

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The invesitgation of zinc cations retention in lung after inhalation exposure

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Zinc oxide

EC Number:

215-222-5

EC Name:

Zinc oxide

Cas Number:

1314-13-2

IUPAC Name:

oxozinc

Details on test material:

see reference

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

see reference

Administration / exposure

Route of administration:

inhalation: dust

Vehicle:

not specified

Details on exposure:

particle size <1micrometer

Duration and frequency of treatment / exposure:

4 hours/day, 5 days/week for 1 day or for 2 weeks, 4 weeks, 8 weeks

Doses / concentrations

Remarks:

Doses / Concentrations:
15 mg ZnOdust/m3

No. of animals per sex per dose / concentration:

48 per sex exposed to 15 mg ZnOdust/m3

Control animals:

not specified

Positive control reference chemical:

no data

Details on study design:

see reference

Details on dosing and sampling:

see reference

Statistics:

see reference

Results and discussion

Preliminary studies:

no data

Toxicokinetic / pharmacokinetic studies

Details on absorption:

see reference

Details on distribution in tissues:

see reference

Details on excretion:

no information

Metabolite characterisation studies

Metabolites identified:

not specified

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): low bioaccumulation potential based on study results
The pulmonary zinc level did not rise throughout the study it can be assumed that pulmonary deposition is very low and/or that pulmonary clearance is very high.

Executive summary:

Male and female rats were exposed to 15 mg ZnO dust/m³(particle size < 1mm) for 4 hours/day, 5 days/week during 1 day or for 2, 4 or 8 weeks. Animals were killed 24 hours after the last exposure and the zinc content of the lungs, liver, kidneys, tibia and femur was measured. After 1 day of exposure the total zinc content of the lung in males and females was about 46 and 49mg, respectively. In lung, liver, kidney and bone only minimal differences in tissue zinc content was seen during the experiment. As tissue zinc levels in non-treated animals were not studied, it is not clear whether tissue zinc comes from the experimental or from dietary exposure. However, as the pulmonary zinc level did not rise throughout the study it can be assumed that pulmonary deposition is very low and/or that pulmonary clearance is very high.