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Diss Factsheets

Toxicological information

Basic toxicokinetics

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Administrative data

Endpoint:
basic toxicokinetics in vivo
Type of information:
experimental study
Adequacy of study:
key study
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:
Biological fate of a representative lipophilic metal compound (ferrocene) deposited by inhalation in the respiratory tract of rats
Author:
Dahl AR, Briner TJ
Year:
1980
Bibliographic source:
Toxicol Appl Pharmacol 1980; 56: 232-9

Materials and methods

Objective of study:
absorption
distribution
Principles of method if other than guideline:
In a peer reviewed study groups of male and female Fischer 344 rats were exposed (nose-only) to ferrocene vapour labelled with 59Fe and tritium.
The exposure duration was 17 minutes and the average ferrocene concentration was 88 mg/m3
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Ferrocene
EC Number:
203-039-3
EC Name:
Ferrocene
Cas Number:
102-54-5
Molecular formula:
C10H10Fe
IUPAC Name:
iron(2+) dicyclopenta-2,4-dienide
Radiolabelling:
yes
Remarks:
59Fe and tritium

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female
Details on test animals or test system and environmental conditions:
23 male and 22 female rats

Administration / exposure

Route of administration:
inhalation: vapour
Vehicle:
unchanged (no vehicle)
Duration and frequency of treatment / exposure:
17 minutes
Doses / concentrations
Dose / conc.:
88 mg/m³ air (nominal)
Control animals:
yes

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on absorption:
Internal deposition was 61.4 ± 3.7 μg per rat, corresponding to 36.6 ± 2.2% of the total inhaled vapour. Estimated ingestion was 5-25 micrograms. The fate of ingested ferrocene is that it sequests in the liver after passage throught the mucosal barrier of the gastrointestinal tract
Details on distribution in tissues:
At the earliest sacrifice time (0hr), 55% of the internally deposited ferrocene was in the nasopharyngeal region, and 30% was in the bronchopulmonary region. The remaining 15% was associated with the gastrointestinal tract or other organs.

Over 75% of the tritium label was excreted within the first day but the 59Fe label largely remained in the bronchopulmonary and nasopharyngeal regions over the duration of the experiment. The remaining 10% of the iron was primarily associated with the liver.

There was a protracted clearance of ferrocene-introduced iron (FII) from the respiratory tract, particulary in the lungs. For the FII remaining after 14 days, half times for clearance of 200 and 70 days can be estimated for the bronohopulmonary and nasopharyngeal regions respectively.

8% of the initially deposited FII was swallowed during or quickly after exposure (fur licking may have contributed to the GI tract FII. Estimated ingestion was 5-25 micrograms. The fate of ingested ferrocene is that it sequests in the liver after passage throught the mucosal barrier of the gastrointestinal tract.
Details on excretion:
Of the total initial tritium burden, 75% was excreted in the urine, about 9% was excreted in volatile components and 2% faeces all within 24 hours.

Only 7% of the Fe59 burden was excreted in the urine within the first 48hr. Overall only 15% of Fe59 was excreted by all routes in this period

Metabolite characterisation studies

Metabolites identified:
not measured
Details on metabolites:
The chemical form of the retained iron was not determined. It was not Ferrocene however as 75% of the tritium label (and correspondingly Cyclopentadiene) was rapidly separated from the ferrocene (24hours)

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): no bioaccumulation potential based on study results For the FII remaining after 14days, half times for clearance of 200 and 70 days can be estimated for the bronohopulmonary and nasopharyngeal regions respectively.

Internal deposition was 61.4 ± 3.7 μg per rat, corresponding to 36.6 ± 2.2% of the total inhaled vapour. Estimated ingestion was 5-25micrograms. The fate of ingested ferrocene is that it sequests in the liver after passage throught the mucosal barrier of the gastrointestinal tract.

At the earliest sacrifice time (0hr), 55% of the internally deposited ferrocene was in the nasopharyngeal region, and 30% was in the bronchopulmonary region. The remaining 15% was associated with the gastrointestinal tract or other organs.

Over 75% of the tritium label was excreted within the first day but the 59Fe label largely remained in the bronchopulmonary and nasopharyngeal regions over the duration of the experiment. The remaining 10% of the iron was primarily associated with the liver.

There was a protracted clearance of ferrocene-introduced iron (FII) from the respiratory tract, particulary in the lungs. For the FII remaining after 14days, half times for clearance of 200 and 70 days can be estimated for the bronohopulmonary and nasopharyngeal regions respectively.