Registration Dossier
Registration Dossier
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EC number: 220-552-8 | CAS number: 2809-21-4
Health surveillance data
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:
- 1 986
- 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
- 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)
- Reference substance name:
- to follow
- IUPAC Name:
- to follow
- Details on test material:
- 14C-HEDP.
No further details.
Constituent 1
Constituent 2
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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