Registration Dossier
Registration Dossier
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EC number: 223-267-7 | CAS number: 3794-83-0
Additional toxicological data
Administrative data
- Endpoint:
- additional toxicological information
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Publication available for review, reasonably well documented study, supports established effects of disodium HEDP on bone.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
Materials and methods
- Type of study / information:
- Type: other: effects on bone
Test material
- Reference substance name:
- Disodium dihydrogen (1-hydroxyethylidene)bisphosphonate
- EC Number:
- 231-025-7
- EC Name:
- Disodium dihydrogen (1-hydroxyethylidene)bisphosphonate
- Cas Number:
- 7414-83-7
- Molecular formula:
- C2H8O7P2.2Na
- IUPAC Name:
- disodium dihydrogen (1-hydroxyethane-1,1-diyl)bis(phosphonate)
- Test material form:
- not specified
Constituent 1
Results and discussion
Any other information on results incl. tables
Body weight was decreased 50-60% in animals given 40 mg/kg
bwt by s.c. injection. Calcium absorption by the small
intestine was significantly decreased (both sexes)while
total plasma calcium was slightly but significantly elevated
in females only. The rate of longitudinal bone growth could
not be determined since disodium HEDP interfered with
tetracycline binding in bone. The proximal tibial epiphyseal
plates were enlarged in both sexes, and the amount of
mineralised tissue present in the proximal tibial metaphyses
increased. There were mineralisation arrest lines in the
metaphyseal spongiosa, which possibly corresponded with the
daily s.c. injections of disodium HEDP.
Body weight was significantly decreased 30-40% in animals
given 360 mg disodium HEDP/kg bwt/d for 28 days. Calcium
absorption by the small intestine was decreased
significantly in both sexes (plasma calcium not reported),
with significant increases in growth plate thickness and the
percentage of mineralised tissue present in the proximal
tibial metaphyses.
Applicant's summary and conclusion
- Conclusions:
- Repeated oral administration or subcutaneous injection of
disodium HEDP resulted in marked changes in osseous tissues
and calcium parameters in male and female rats.
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