Registration Dossier
Registration Dossier
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EC number: 701-238-4 | CAS number: -
Additional toxicological data
Administrative data
- Endpoint:
- additional toxicological information
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- No data
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Effect of sodium etidronate in adult cats
- Author:
- Jowsey, J, Holley, KE and Linman, JW
- Year:
- 1 970
- Bibliographic source:
- J Lab Clin Invest 76, 126 - 133
Materials and methods
- Type of study / information:
- Effects on bone.
Test guideline
- Qualifier:
- no guideline followed
- GLP compliance:
- no
- Remarks:
- pre-GLP
Test material
- Reference substance name:
- Sodium Salts of (1-Hydroxyethylidene)bisphosphonic acid (2-3 Na:1)
- EC Number:
- 701-238-4
- Cas Number:
- 29329-71-3
- Molecular formula:
- HEDP-2Na C2H6Na2O7P2 HEDP-3Na C2H5Na3O7P2
- IUPAC Name:
- Sodium Salts of (1-Hydroxyethylidene)bisphosphonic acid (2-3 Na:1)
- Test material form:
- not specified
- Details on test material:
- CAS No. 7414-83-7
Described as sodium etidronate, presumed disodiumethane-1-hydroxy-1,1-diphosphonate, source and purity not stated.
No further information.
Constituent 1
Results and discussion
Any other information on results incl. tables
Six of seven cats given 500 mg/kg sodium HEDP (nominal) died
following 4 week treatment. Increased serum creatinine noted
in most decedents.
Histopathological examination of the kidney from cats given 50
or 500 mg/kg bw/day (nominal) for 6 weeks showed acute and
chronic inflammatory changes affecting both interstitial and
tubular elements (no further details). No renal changes were
noted in cats given 25 mg/kg bw/day (nominal) for 6 months.
Bone sections demonstrated a significant (P<0.01) increase
in osteoid tissue width in cats given 500 (2.4-fold) or 50
(1.7-fold) mg/kg bw/day (nominal) for 6 weeks. Similar increases
(reported as 2) were present in cats given 1 - 25 mg/kg
bw/day (nominal) for 6 months.
The authors note that the effect of sodium HEDP on one
appears to be minimal at doses 25 mg/kg bw/day (nominal)
for 6 months, however (based upon the limited evidence presented
in this paper) a comparable effect also appeared to be
present in the low dose animals. Overall, therefore, these
results suggest that 1 mg/kg bw/day (nominal) over 6 months is a
LOAEL for increased osteoid activity in the cat, however, the
reliability of the underlying data is considered low.
Applicant's summary and conclusion
- Conclusions:
- In a study investigating the effects on bone (reliability score 4), not conducted according to any OECD Test Guideline and pre-GLP, a LOAEL of 1 mg/kg bw/day was determined based on increased osteoid activity in the cat.
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