Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
health surveillance data
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
No data
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only a summary report was available for review.

Data source

Reference
Reference Type:
secondary source
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Study type:
other: Human absorption study.
Endpoint addressed:
basic toxicokinetics
Test guideline
Qualifier:
no guideline available
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Etidronic acid
EC Number:
220-552-8
EC Name:
Etidronic acid
Cas Number:
2809-21-4
Molecular formula:
C2H8O7P2
IUPAC Name:
(1-hydroxyethane-1,1-diyl)bis(phosphonic acid)
Constituent 2
Reference substance name:
to follow
IUPAC Name:
to follow
Details on test material:
14C-HEDP.
No further details.

Method

Details on study design:
A single oral dose of 0.3 mg/kg bw 14C-HEDP was administered to eight volunteers. Group A (n=5) received HEDP after breakfast, and Group B (n=3) before breakfast. Absorption was determined by measuring the activity excreted with urine and faeces.

Results and discussion

Results:
The activity excreted with urine was 0.082% (Group A) and 0.532% (Group B) of the applied dose.

Applicant's summary and conclusion

Conclusions:
In a summary of a human oral absorption study (reliability score 4) a single oral dose of 0.3 mg/kg bw 14C-HEDP was administered to eight volunteers. Group A (n=5) received HEDP after breakfast, and Group B (n=3) before breakfast. Absorption was determined by measuring the activity excreted with urine and faeces. The activity excreted with urine was 0.082% (Group A) and 0.532% (Group B) of the applied dose.
Executive summary:

In a summary of a human oral absorption study (reliability score 4) a single oral dose of 0.3 mg/kg bw 14C-HEDP was administered to eight volunteers. Group A (n=5) received HEDP after breakfast, and Group B (n=3) before breakfast. Absorption was determined by measuring the activity excreted with urine and faeces. The activity excreted with urine was 0.082% (Group A) and 0.532% (Group B) of the applied dose. This result was comparable that of a similar study in rats (see Section 7.1.1.).

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