Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
experimental study
Adequacy of study:
disregarded due to major methodological deficiencies
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: no test guideline stated, GLP compliance

Data source

Reference
Reference Type:
other: inquiry result from ECHA
Title:
Unnamed
Year:
2013

Materials and methods

Objective of study:
other: see field "Details on study design"
Test guideline
Qualifier:
according to guideline
Guideline:
other: No specific reference to the test guideline has been given.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
425-320-1
EC Name:
-
Cas Number:
690-39-1
Molecular formula:
C3H2F6
IUPAC Name:
1,1,1,3,3,3-hexafluoropropane
Radiolabelling:
no

Test animals

Species:
other: rats

Administration / exposure

Route of administration:
inhalation
Vehicle:
other: None
Details on exposure:
Method of administration or exposure: Closed chamber recirculating gas uptake system
Duration and frequency of treatment / exposure:
Duration of exposure per day: 6 hours
No. of animals per sex per dose / concentration:
Male: 3 animals at 100 mg/kg
Male: 3 animals at 530 mg/kg
Male: 3 animals at 2350 mg/kg
Male: 3 animals at 7300 mg/kg
Male: 3 animals at 18000 mg/kg
Details on study design:
Objective of study: The aim of the studies was to measure tissue:air partition
coefficients and to describe the kinetics of the substance,
via recirculating gas uptake exposure methods, and to look
for and identify potential metabolities in blood and urine
after inhalation exposure to the substance.

Results and discussion

Any other information on results incl. tables

- The PBPK model could no adequately describe the disappearance of the substance from the chamber atmosphere during gas uptake experiments with the assumption that metabolism was the cause of chemical disappearance. The pattern of loss was, in fact, inconsistent with either first-order or saturable metabolism.

- Possible cause of the unexplained loss may be associated with carbon dioxide exhalation during the exposure although final confirmation would require further investigation.

- The substance had low solubility (partition) in blood and tissues and had minimal, if any, enzymatic metabolism in rats

- Explicit analyses for potential metabolities in blood, urine, and feces failed to detect anything but the substance

itself.

Applicant's summary and conclusion

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